IECEE

OD-2020-Ed.1.7
OPERATIONAL & RULING DOCUMENTS

TRF – Development,
maintenance and use

OD-2020-Ed.1.7 IEC - IECEE 2010 - Copyright

2010-01-15 All rights reserved

Except for IECEE members and mandated persons, no part of this publication may be reproduced or utilized in any form or by any
means, electronic or mechanical, including photocopying and microfilm, without permission writing from the publisher

IECEE Secretariat, 3, rue de Varembé, Geneva, Switzerland, Telefax : +41 22 919 0300, e-mail : [email protected]
 Worldwide System for Conformity Testing and Certification
of Electrical Equipment and Components (IECEE)

TRF – Development,
maintenance and use
This TRF Manual has been prepared by the IECEE CMC TRF Working
Group and approved by the Certification Management Committee (CMC)
of the IECEE

CONTENTS Page

Part 1 General introduction to the TRF procedures 3

Part 2 Assignment and distribution process 4
Part 3 Guidelines on how to prepare new TRFs 6
Part 4 Guidelines on how to fill in the TRFs 16
Part 5 Guidelines on how to prepare Amendment Reports 19
Part 6 Requests for modifications to TRFs 21
Annex A Helpful hints for TRF Originators 23
Annex B Checklist for TRF Originators 26
Annex C Example of Test Report and National Differences Forms 28
Annex D Example of a TRF page in landscape orientation 39
Annex E Instructions on how to complete Test Report pages 41
Annex F Example of Amendment to the original Test Report 56
Annex G TRF flowchart for Originators/Administrator/Users 62
Annex H Distribution of TRFs 63
Annex I Request form for TRF modifications 64
Annex J TRF templates and list of available TRFs 65

OD-2020-Ed.1.7 2/65
2010-01-15 © IECEE 2001-2010 - Copyright – all rights reserved
Except for IECEE members and mandated persons, no part of this publication
may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission writing
from the publisher

IECEE Secretariat, 3, rue de Varembé, Geneva, Switzerland, Telefax : +41 22 919 0300, e-mail : [email protected]
 Worldwide System for Conformity Testing and Certification of
Electrical Equipment and Components (IECEE)

Part 1
General introduction to the TRF procedures

1.1 Scope

This Operational Document (OD) addresses various stages of Test Report Form (TRF) development,
distribution, maintenances and use. It also includes various examples to illustrate the requirements.

1.2 Purpose

For the most part, this OD has been prepared to address the needs of TRF originators, TRF users and
TRF administrators. The purpose of this OD is to guide all parties involved in the TRF procedures and to
address the certification, data exchange and other IECEE community needs, as appropriate.

1.3 Definitions

Test Report Form (TRF) – A blank form prepared by the TRF originator according to Part 3 of OD CB
2020 and published according to Annexes G and H of this Operational Document.

TRF Originator – An NCB appointed by IECEE to develop a specific Test Report Form.

CB Test Report – A filled out Test Report Form (TRF), containing results of product investigation,
measured test data and attachments per the list of attachments referring to supporting documents. (See
Annex E for instructions).

1.4 Structure of OD CB 2020

The OD consists of six Parts and ten Annexes, which compliment each other and together describe the
complete TRF process. Individual Parts may be used to serve a specific purpose, for example, Parts 4
and 5 address the needs of CB Test Report compilers.

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Part 2

Assignment and distribution process

2.1 Request for a TRF

The request for a TRF is basically made by an IECEE member, which has presumably received an
application for testing and certification of product(s) falling under a determined standard. The request
shall be addressed to the IECEE Secretariat in writing to the following email address: [email protected]
Upon receipt, the IECEE Secretariat checks whether the requested TRF is:
- Already available;
- Available but requiring updates;
- In process of being originated/updated by an assigned IECEE member;
- Not available.

2.1.1. If the requested TRF is already available or in process of being originated/updated, the
requesting IECEE member is notified by the Secretariat.

2.1.2. If TRF is not available or an update is needed but not available:

a). In case the requested TRF is an update and has been previously assigned to or prepared
by other member, the IECEE Secretariat will consult with that member prior to making
any additional inquires among participating NCBs.

b). In case the originator is not able to update the TRF within a defined time frame, or there
is no assigned originator for the TRF, the requesting IECEE member will be asked to
originate the relevant TRF. However, as a pre-condition, the requesting member must
have been accepted to issue CB Test Certificates based on the relevant IEC standard.

c). If the requesting member is not prepared to develop the TRF, the IECEE Secretariat
immediately starts a formal consultation among other members seeking an NCB willing to
originate the missing TRF.

Note: It is assumed that the NCB, which has got the application for certification purpose,
will undertake the responsibility of originating the TRF, should the consultation made by
the IECEE Secretariat among the IECEE members lead to a no-offer. In case no
originator can be found, the requesting member is expected to drop the TRF request.

2.2 Appointment of TRF Originator

The IECEE Secretariat will formally appoint an IECEE member as a TRF Originator according to a), b) or
c) above, as appropriate.

The originator will develop the assigned TRF following the requirements in Part 3.

2.3 TRF Distribution of new and modified TRFs

Once the appointed originator completed the TRF, the originator forwards the relevant TRF in MS Word
format to the IECEE Secretariat via email. See Annex H.

The TRF originator shall advise the IECEE Secretariat whether the TRF should be distributed via regular
or via simplified procedure (See Annex G and clause 6.3 for details).

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2.4 TRF Trial and Comment Period

New TRFs that are not distributed via simplified procedure can be used on a trial bases for three to six
months. IECEE distributes the TRF to members and publishes on the IECEE Website as a provisional
TRF.
During the trial and comment period, users are expected to provide feedback to the IECEE Secretariat
(See Part 6). IECEE Secretariat informs the TRF originator about the findings and requests that
comments be addressed, when appropriate.

For new or updated TRFs, the IECEE Secretariat will verify the correct Test Report Reference Number,
layout, editing, etc prior to publishing the TRF in the relevant areas of both, the IECEE Web Site for the
members and the IEC Web Store for outsiders, or return to the originator for corrections.

The IECEE Secretariat informs the IECEE members about the publication through e-mails each time a
new TRF(s) are posted on the IECEE Web Site and IEC Web Store.

Part 6 of this OD describes the process addressing users’ requests for modifications to the content of a
TRF, as well as, administrative changes.
Annexes G and H describe the procedure for TRF modification requests and distribution.

2.5 Simplified procedure for TRF distribution

The simplified procedure for TRF distribution is described in Clause 6.4 and in Annex G.

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Part 3
Guidelines on how to prepare new TRFs

3.1 General rules

The originator shall always use the latest TRF template available on the IECEE Website.
(http://www.iecee.org/cbscheme/html/cbtrep.htm). This applies to the TRF itself and to the National
Differences TRFs.

3.1.1. As a basic rule, one TRF covering IEC requirements shall be developed. For the EN
standard an EN Annex covering EN Differences shall be attached to the IEC TRF. If a separate
TRF according to the EN standard is necessary due to a considerable number of EN Differences,
this shall be agreed with the IECEE Secretariat.

3.1.2. The EN Annexes and in specific situations, EN TRFs respectively, shall be prepared by the
originator located within EU countries, which might result in a different originator for the IEC Test
Report Form and for the Annex with EN Differences.
The originator shall always use the latest EN Differences and National Differences templates
available from the IECEE Website.

3.1.3. In general, a separate TRF shall be prepared for Part 1 and for each Part 2 standard.
However, the originators may choose to prepare a TRF for a combined Part 1 and one or more
Part 2 standards (Example: IEC 60335 and IEC 60598 Series). For uniformity of all TRFs in a
particular series of standards, the originator shall always start with the approved Part 1 TRF,
when available, and incorporate into it Part 2 requirements (See Clause 3.7.3).

3.2 Formatting requirements

The following formatting and identification instructions shall be taken into account when preparing new or
modifying old test report forms (TRF):

File format: MS Word format "97-2002 + 6.0/95 - RTF" or "97-2003 + 6.0/95 - RTF"

Font: Normal text: Arial 10 pt (True Type)

Special characters (e.g. , ): Symbol (True Type)
Paper size: A4 (210 x 297 mm)

Margins: Top 2 cm, Bottom 2 cm, Left 3 cm, Right 1 cm (standard margins)
Optional: Left 2 cm, Right 2 cm (CBTL using double sided printing may modify the margins)

Language: English (UK)

3.3 Identification of the IEC Standard, TRF number and Master TRF

The TRF standard shall be identified on the front page as follows:

Standard: IEC 6xxxx - x-xx: YEAR (xx Edition)

For Part 2 TRF the above shall be followed by the reference to the correct Part 1.

Examples:
• IEC 60601-2-2:2006 (Fourth Ed.) for use in conjunction with IEC 60601-1 (1988), Amts 1 (1991)
and 2 (1995)
• IEC 60601-2-22: 2007 (Third Ed.) for use in conjunction with IEC 60601-1: 2005 (Third Edition)
• IEC 60335-2-4:2002 (5th Ed.) and IEC 60335-2-7:2002 (6th Ed.) for use in conjunction with
IEC 60335-1:2001 +A1:2004

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Test Report Form Number:

The TRF Number providing reference to the IEC standard shall be identified on the front page. A
letter code shall be added to the number to identify the TRF version.

The format of the TRF identification shall include the following elements:
IEC6xxxx_x_xxx followed by suffix letter

Examples:
• IEC60950_1F: means a TRF for IEC 60950-1, TRF version “F”
• IEC60601_2_22C means a TRF for IEC 60601-2-22, TRF version “C”
• IEC60335_2_4&7D: means a TRF for IEC 60 335-2-4 and IEC 60 335-2-7, TRF version “D”
• IEC60335_2_23B_delta: means a TRF for IEC 60 335-2-23 covering differences between
version “A” and version “B” (See Clause 3.7.1).
• IEC60950_1&IEC60601_1A: means a TRF covering two different standards IEC 60950-1 and
IEC 60601-1, TRF version “A” (see Clause 3.7.2).
• EU_GD_IEC60335_2_14F means a TRF covering European Group Differences for
IEC60335-2-14 version “F” (see Clause 3.4.5)
• US_ND_IEC60065_7th.ed.am.1 means a TRF covering US National Differences for
IEC60065, 7th ed. with am.1 (see Clause 3.4.5)
• MY_ND_IEC60065_7th.ed means a TRF covering Malaysian National Differences for
IEC60065 TRF, 7th ed.

Note: The suffix letter in the TRF identification number is reserved for a version and is added by
the TRF Originator. (In case of doubt, the IECEE Secretariat acting as the TRF Administrator will
verify the correctness of the TRF number).

Master TRF: The date of Master TRF shall be the date of TRF publication. See also Clause
6.3.7.

3.4 TRF structure

A Test Report Form must be easy to fill in and shall not include macros, except for the Test Report
Number and the page numbers. Check boxes may be used as allowed by the TRF template. The
originator may add protected fields but only if necessary. See instructions in Annex A.

A blank Test Report consists of four sections as specified below. The Testing Laboratory always
completes the first four sections including the critical components (section four). (See Annex E).
If National Differences are included during product investigation (see clause 3.4.4) then an attachment
covering National Differences shall also be completed.

3.4.1. General information section (Section 1 of the TRF)

The first section is a cover page – applicable to all Test Reports - that contains the general
information, such as names and addresses of Testing Laboratory and Applicant/Client, Report
reference number, standard used, TRF number, product name and product rating, trademark
and other information.
An example of the first page of TRF is shown in Annex C.

Pages that follow the cover page (normally three or more pages) contain specific information
related to testing procedure and testing locations, list of attachments, product under testing,
investigated National Differences, general tests and samples information.
An example of information pages can be found in Annex C.

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3.4.2. Compliance checklist (Section 2 of the TRF)

This section of the TRF is a standardized section consisting of a checklist, referencing clause by
clause the requirements of a particular IEC standard.
Note 1: Sub-clauses that are explanatory notes do not need to be detailed in the checklist.

The compliance checklist section is formatted into 4 columns. For practical reasons each
column heading (below) appears as a table heading on each page of this section, e.g. the whole
section may be one table and the table heading is repeated at the beginning of each page.
When this is not practical, the table may be split into several smaller tables, however, the
headers are repeated on each page.

Cl. Requirement - Test Result Verdict

In order to fully utilize the available space on each page, the typical width of each cell in the test
case section shall be as follows: 2 cm, 8.3 cm, 5 cm and 1.6 cm. (Note: A4 page width is 21
cm, margins 4 cm and about 0.1 is left for lines width).

Cl./Clause: a reference to the standard’s clause or sub-clause

Note 2: Identical clause numbers of subsequent test cases are not repeated (printed) in the
compliance checklist table.

Requirement – Test: a summary of the requirement and/or an abbreviated description of a test.

Different test case types may be presented in one of the following ways (each type is followed
by an example).

3.4.2.1. Test case types

Heading

Cl. Requirement - Test Result Verdict

30 CONSTRUCTION

Sub-heading

Cl. Requirement - Test Result Verdict

10.5 Markings for Class II appliances Pass

Regular test case

Cl. Requirement - Test Result Verdict

21.1.1 Marking on main part Pass

When regular test case requires a specific result or comment in addition to the verdict, it
needs to be identified by a dotted leader as in the example below:

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Cl. Requirement - Test Result Verdict

20.5 Length  10 m .........................................: 12,5 Pass

Auxiliary test case, not requiring a verdict but additional information only, needs to be
identified by a shaded verdict field (shading is12.5% gray):

Cl. Requirement - Test Result Verdict

3.2.1 Test temperature (°C).............................: 23,5 —

3.4.2.2. Results and verdicts

Result: Any information that results from column 2, such as a measured value, a
remark or an explanation, if applicable.

Verdict: A judgment resulting from analysis of columns 2 and 3. Allowed verdict

choices are:
Pass
Fail
N/A (Not applicable)

3.4.3. Measurement section (Section 3 of the TRF)

This section contains tables with the measured values, specific test conditions,
test remarks and additional testing information.
All measurement tables shall have supplementary information field at the bottom of the table to
provide room for clarification of test parameters.
An example of a measuring section is shown in Annex C and Annex E.

3.4.4. Critical components and/or materials section (Section 4 of the TRF)

A table describing critical components and/or materials is an integral part of each TRF.
The Critical Components and Materials table shall be the last section after the measurement
section to assist in prompt identification of component information in the Test Report. This table
has only the title and no number. It can have two styles of rows. The first style has six
columns:

a). Object / part No. => name of component or identifier, for example mains switch, T10, C3, F1
(ID of the components on schematics, wiring diagrams, and similar), main enclosure, bottom
plate, terminal pins….

b). Manufacturer/trademark => the manufacturer’s name shall be specified, except for some
materials (for example metal plate, heat sink, terminal pins) or for generic components
specified in CTL Decisions, such as PWB.

c). Type / model => When applicable, a designation that allows identification of the component

d). Technical data => relevant ratings and/or characteristics for components that are critical for
compliance with the standard (for example the following may apply but is not limited to
electrical component ratings, material thickness, flammability rating and similar)

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e). Standard => Applicable IEC or National harmonized component standard, or product
standard if investigated as part of the product

f). Mark(s) of conformity => Provided evidence ensuring the agreed level of compliance. See
OD-2039.

The second row style is to allow more space for additional information. This row consists of two
columns: “Description” and a free text field.

A typical component table has the following layout:

TABLE: List of critical components

Object/part Manufacturer/ Type/model Technical data Standard Mark(s) of
No. trademark (Edition / year) conformity1)

- Description:

Supplementary information:
1) Provided evidence ensures the agreed level of compliance. See OD-2039.

Note: The free text field provides additional space for information that may not fit in the
standard cell format. The use of this row is optional, and when used, it is always in conjunction
with the object/part number specified in the row above it.
A completed table is provided in Annex E.

3.5 Standardized attachments

3.5.1 National Differences (when applicable)

a). This attachment is used for National Differences requirements. The National Differences
Test Report Forms are structured as described in Clause 3.4.2 except a unique cover page is
used for National Differences TRFs. A measurement section may also be included (as in clause
3.4.3) when needed to record specific measurements.

Note: By National Differences it is meant National Differences, Group Differences and Special
National Conditions. Normally, the National Differences TRFs are provided by Member Bodies
at the time of the Acceptance of Standards used in the IECEE CB Scheme as the basis for the
national certification or are prepared by the originator appointed by IECEE Secretariat.

b). Countries listed in the “Summary of compliance with National Differences” field may only
include those countries for which either a completed National Differences TRF is attached or
those countries that declared no National Differences.

c). When the investigation covers more than one edition of the standard, a TRF that includes the
requirements from more than one standard edition may be used (see clause 3.7). In this case
the attached National Differences TRFs may also address National Differences to more than
one edition of the standard as applicable for the target countries requested by the Applicant.

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d). Individual National Differences TRFs may be combined into one attachment with all pages
numbered sequentially or each National Differences TRF might be placed one after the other,
however, the list of attachments must include the list of all National Differences TRFs attached.
A separate National Differences TRF for Part 1 and Part 2 Standards may also be combined
into one attachment with all pages numbered sequentially.

Examples of TRFs for National Differences are shown in Annex C and in Annex E.

3.5.2. List of Test Equipment (when applicable)

The CB Test Reports generated under Manufacturer’s Testing Programs, TMP and WMT shall
contain an attachment, listing test equipment utilized during the testing. The equipment list is
optional for SMT and RMT programs.

Note: Annex C and E include an example of the required attachment for testing conducted
under the manufacturer testing programs, TMP and WMT. The form is optional for SMT and
RMT programs. Other forms with a different layout but containing corresponding information
are also acceptable.

3.6 Instructions for TRF originators

3.6.1. The “Requirement – Test” column in the TRF is a summary of the requirement. The full
text of the standard shall not be repeated.

3.6.2. All pages of the Test Report Form shall be numbered continuously with the total number
of pages indicated.

3.6.3. The TRF is a part of the conformity assessment, therefore, the wording used in the
“Requirement – Test” column needs to be simple and needs to prompt for a clear “Pass”, “Fail”
or “N/A” verdict. (Acceptable verdicts are also repeated in the TRF template).

3.6.4. Words such as “shall” and “should” are normally reserved for requirements and
recommendations in the standard, respectively. Since the Test Report requires a confirming
verdict for each clause, it is necessary to use indicative rather than imperative phrases when
abbreviating the requirements.

(Example:
Instead of: “Time-delay fuse shall be used”, the correct wording in the TRF states “Use of time-
delay fuse”.)

3.6.5. Sub-header style in the TRF should be used when many regular test cases apply to the
same header. However, the use of too many sub-headers in a sequence without any regular
test case entries that follow the sub-headers should be avoided when possible. It makes the
TRF too lengthy, difficult to handle and computerize.

3.6.6. Special care must be taken to avoid situations in which a “Fail” verdict in the Test Report
could be acceptable in overall product compliance.

Example:
Provided example is based on the IEC 60950, Third Edition.
The standard calls for a flammability test and allows repeating that test or running an alternate
test in case of a failure. Therefore, the “Fail” verdict would be entered in the TRF for the first
test, in which the failure occurred. In order to avoid this situation, the TRF originator must
design the report form in such a way as to avoid the negative results. This could be
accomplished by any of the methods presented below or similar, equally effective.

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3.6.6.1. TRF may provide instructions for CBTL in the “Remarks” column:

A.6 Flammability tests for classifying materials V-0, V-1 or V-2 Pass
A.6.1 Samples, material.................................... : Material designation FR-556 
Wall thickness (mm) ................................ : 0.5 
A.6.5 Flammability test compliance criteria Note: This clause is not N/A
applicable if test per A.6.6 was
conducted
A.6.6 Permitted re-test All samples of the second set Pass
met the relevant criteria.

3.6.6.2. TRF may combine both tests in one clause and a comment can clarify the testing.

A.6 Flammability tests for classifying materials V-0, V-1 or V-2 Pass

A.6.1 Samples, material.................................... : Material designation FR-556 

Wall thickness (mm) ................................ : 0.5 

A.6.5 Compliance criteria and permitted re-testing All samples passed the Pass
A.6.6 permitted re-testing.

3.6.6.3. TRF may utilize "type 3 verdict" (Auxiliary test case, requiring additional information but
not a verdict):

A.6 Flammability tests for classifying materials V-0, V-1 or V-2 Pass
A.6.1 Samples, material.................................... : Material designation FR-556 
Wall thickness (mm) ................................ : 0.5 
A.6.5 Flammability test ..................................... : Add comment as appropriate 
A.6.6 Permitted re-test...................................... : Add comment as appropriate 
Compliance criteria for flammability tests Pass
and re-tests

3.7 TRF Originator’s responsibility before submitting Test Report Form to IECEE

3.7.1 Care must be taken to avoid common TRF mistakes before submitting the TRF to
IECEE for distribution to members.
3.7.2 The originators are expected to validate the TRF using the checklist for TRF
Originators (See Annex B).

3.8 Special case TRFs

Special case TRFs are only developed when IECEE members have identified market needs. They are
not applicable and /or practical for all product categories.

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3.8.1 Generating integrated TRFs covering different editions of the same standard

Note: Model 3 TRF described in Document IECEE CMC/509/RCMC.

3.8.1.1 In order to efficiently cope with situations where manufacturers target the worldwide
market and wish to seek a CB Test Certificate that covers more than one edition of a particular
standard (e.g. IEC 60950-1, First edition and IEC 60950, Third edition and IEC 60950, Second
edition with Amendments 1-4), a TRF that includes the requirements from more than one
standard edition may be developed.

a) The structure of the TRF (shown here based on the example of IEC 60950) shall be as
follows:

b) Full TRF is based on the latest standard edition

c) Delta TRFs include the requirements from the previous edition(s).

3.8.1.2 Rules for the preparation of Delta TRFs:

a) If the latest edition has more stringent requirements, the Delta TRF does not need to list
these requirements
b) If an alternate or new test method is in the latest edition, the old test method needs to be
included in the Delta TRF
c) The Delta TRF shall always contain more stringent requirements not existing in the latest
edition.

Note: If there are conflicting requirements in the previous and the new edition, or when the
product cannot meet the more stringent requirements in the new edition, the NCB must use the
TRF for the previous edition of the standard. The use of Delta TRFs is not allowed in this case.

3.8.1.3 Proposed wording when completing Delta TRFs:

In case the TRF originator feels that for the clarity of the overall Report, the Delta TRF should
contain clauses that are already included in the new edition TRF, the following wording may be
used when completing the Delta TRF:
”Compliance with Clause XX of the new edition of the standard fulfils the requirements of this
Clause.”

3.8.1.4 TRF identification:

The Delta TRF is identified by suffix “delta” added to the TRF reference number according to
Clause 3.3.

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Example: The suffix “delta” added to the “B” version means a TRF, which covers differences
between version “A” and version “B” of the corresponding editions of the IEC standard.

3.8.2. Generating integrated TRFs covering two different standards

3.8.2.1 This type of product combination TRF benefits particular segments of some industries
where there is a need to have the identical device complying with more then one IEC standards.

Note: An example within the medical industry includes power supplies, which often need to
comply with two safety standards, IEC 60601-1 for Medical products and IEC 60950-1 for IT
products. Typically, these are IT equipment and associated power supplies that will need to
additionally comply with IEC 60601-1 either due to a specific application or in consideration of
the manufacturer’s desire for broader market access.

3.8.2.2 Product combination TRFs are supplements to the existing TRFs based on a product
and not on a single IEC standard; they may be developed across various categories.

3.8.2.3 When creating a product combination TRF, one standard is selected as the main
standard. The selected main standard shall cover the majority of the required tests.

Example: IEC 60950-1 selected as main standard and supplement TRF for combination with
IEC 60065, or IEC 60601-1, or IEC 61010-1.

3.8.2.4 TRF Originator shall identify the most severe requirements in all applied standards
and eliminate Clauses that are not applicable to the investigated product.

3.8.2.5 The originator shall identify common requirements to avoid duplication in the
supplementary TRF.

3.8.2.5 Any additional requirements that address the use (for example: outdoor use, high
altitude use, hospital environment or other application considerations) are to be identified and
included in the combination TRF.

3.8.2.6 The combination TRFs shall be so designed that the supplemental Annex can only be
used for a specific product it has been prepared for and together with the main standard TRF.

3.8.2.7 Cross references as in the example below are acceptable.

In a supplement TRF developed to include IEC 60601-1 requirements for product investigated
according to IEC 60950-1:

Clause Requirement + Test Result - Remark Verdict

1.1.1 Test name (for example input test) See Test Report for IEC60950-1 Pass

3.8.2.8 To ensure the acceptance of product combination TRFs by Receiving NCBs, the
appointment of TRF originator and the distribution of TRF shall follow the OD CB 2020. Only
the approved and officially published product combination TRFs shall be used.

3.8.2.9 The NCBs have an option of using the approved, complete TRFs for the product in
question instead of the product combination TRFs.

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3.8.3. Generating TRFs combining several Part 2 standards

3.8.3.1 This type of combination TRF may benefit particular segments of the industry where
there is a need for a report addressing products combining several features into one appliance
within the same product category.

Note: Examples of such TRFs within the HOUS category are

- a washing machine with a spin extractor and tumble dryer (IEC60335_2_4&7&11)
- stationary cooking ranges, hobs, ovens and deep fat fryers or frying pans (IEC60335_2_6&13)
- a room heater and clothes dryer/towel rail IEC60335_2_30&43.

3.9 An example of a Test Report Form

For an example of a TRF see Annex C.

Note: The selected example is from the TRF for IEC 60601 Part 2 and contains a statement:
“This Test Report Form is intended for the investigation of …. in accordance with IEC 60601-2-
xx. It can only be used together with the IEC 60601-1 Test Report.”
For TRFs that combine Part 1 and Part 2 requirements into a one Test Report Form, this
statement is not applicable.

3.10 Use of landscape oriented pages in the TRF

The Test Measurement section of TRF may contain large tables. If it is not practical to continue the
table using the “portrait” orientation due to the large size, the table may be designed and printed in
the landscape format. An example of a TRF page in landscape orientation is shown in Annex D.

In case of the landscape orientation the margins shall be as follows:

3 cm from the top of the table and 2 cm from the bottom, and
2 cm left and right margin from the table.

3.11 Use of abbreviations used in the report TRF

When abbreviations are used throughout the report, they shall be clarified. See an example in
Annex F, Page 60.

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Part 4
Guidelines on how to fill in TRFs

The following shall be taken into account when completing a test report form (TRF):

Examples of completed Test Report pages and instructions on how to complete Test Report page are in
Annex E.

4.1. Modifications to the TRFs

The Test Report Forms shall not be modified. However, to help preserve the environment, when
compiling the Test Report, whole clauses of the TR may be omitted as specified in Annex E if they are not
applicable to specific product.

4.2. Completing TRFs

When completing each sub-clause of the TRF, comments indicating why the particular item passed, failed
or is not applicable should be included as necessary for clarity. The Report shall provide sound, sufficient
information to grant the certification without the necessity to conduct additional evaluation or testing.

Note: Therefore, whenever possible the Test Report should also be accompanied by additional
information, such as schematics, insulation diagram, detailed component information and report
on compliance with National Differences.

4.3. A blank Test Report consists of four sections.

Testing Laboratories shall complete, as a minimum, these four sections. The Test Report shall include
photos (see clause 4.10.1). The Report may also contain additional attachments, such as for example,
National Differences TRF(s).

4.4. First section of the TRF

The first section (general information) includes a cover page that contains the general information,
such as names and addresses of Testing Laboratory and Applicant/Client, testing location,
standard used, product name, model(s) and rating(s). This page shall be always completed.
4.4.1 In case of the LTR program use, the following cases may apply:

- When LTR is associated only with the NCB:

CB Testing Laboratory .................. : N/A – LTR program used under the supervision of the NCB

- When a CBTL is appointed for the supervision of the LTR:

CB Testing Laboratory .................. : The name and address of the appointed CBTL

4.4.2 Pages behind the cover page contain signature page, testing laboratory information, factory
list, specific information related to the product under test, marking details, and other general
testing and report information.

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4.5. Second section of the TRF

4.5.1. The compliance checklist is the second section of the Test Report formatted into 4 columns.
The first two columns titled: “Clause” and “Requirement-Test” are provided for reference only and
shall not be modified by the Testing Laboratory. For the complete text of the requirement, testing
engineers shall refer to the standard. In case of any discrepancy between the standard and the
TRF, the standard text shall prevail.

4.5.2. The next column, called “Result”, needs to be completed as part of the investigation. In this
column a measured value or an explanation shall be typed; anything that results from the
requirement in column two. The fourth column confirms the compliance, states non-compliance or
declares the particular clause as not applicable. The verdicts can be “Pass” (“P”), “Fail” (“F”) or
“N/A”. See also TRF template.

4.5.3. Since there are different test case types in a TRF, the Testing Laboratory shall pay special
attention to the type of the clause in order to correctly complete the TRF.

4.6. Third section of the TRF

4.6.1. The third section contains tables and may contain special remarks.
Tables are provided to record the actual measurements taken during the test. It is not allowed to
use statements such as “OK”, “meets the standard”, “more than”, “less than”, or similar instead of
the measured value, unless otherwise specified by CTL.

4.6.2. Tables also provide room for information about test conditions (supplementary information
field). When completing measurement tables, traceability of measurement must be ensured. When
necessary table rows can be multiplied, however, adding new tables or removing tables is not
allowed.

Note: Examples of measurement tables containing test data for more than one model or part are
shown in Annex E.

4.7. Fourth section of the TRF

4.7.1. The fourth section contains a table describing critical components and/or materials.

4.7.2. The information to be included in the critical components and materials table shall be based
on the following:

a). The CTL clarification: “A safety critical component can only be determined upon a
preliminary examination/evaluation of the electrical diagram/design/construction. When the
design of the product is such that a determined component, in case of failure, can
compromise the safety aspect, this component is defined as “safety critical”.
b). Components, which have specific requirements in the end product standards.
c). Components, which have requirements in the National Standards included in the
evaluation
d). Materials, which are critical to maintain compliance with the standard (such as corrosion
requirements, flammability)
e). Professional judgment of the CBTL/NCB.
Note: Additional information can be provided in the free text field of a Description row. An example
is shown in Annex E.

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4.8. Attachments to the CB Test Reports

4.8.1. A complete Test Report shall contain an attachment with photos of the product taken
according to CTL-OP 107, Guide on Use of Photographs in CB Test Reports.

4.8.2. An attachment addressing National Differences may be completed when requested by the
Applicant. This attachment may be a merge of selected National and Group Differences TRFs into
one document. The National Differences attachment shall have its own numbering of pages with a
total number of pages indicated. An example of a completed ND TRF is provided in Annex E.
The “Summary of compliance with National Differences” field shall only contain the list of countries for
which National and/or Group Differences have been addressed.

Optional compliance statement referring to the national or regional standard may also be used:

The product fulfils the requirements of _________ (insert standard number and edition and delete the
text in parenthesis).

4.8.3. Completed list of used test equipment shall be provided as an attachment to the Test Reports
when a Manufacturer Testing Laboratory TMP or WMT has been utilized. (Optional for SMTL and
RMTL where quality system verified by the NCB ensures appropriate document control system in
place). See Annex E for example of the equipment table.

4.8.4. According to IECEE 02, Clause 4.2.2, Test Reports may contain additional attachments, such
as product description and other information necessary for identification of the product, additional test
data, schematics, component licenses, and similar

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Part 5
Guidelines on how to prepare Amendment Reports
5.1. General
An Amendment Report can only be issued to the original CB Test Report. The Amendment shall state
that it is not valid without the original CB Test Report. The original Test Report reference number shall be
clearly identified in the Amendment to allow for logical tracking of product changes.

Amendment Reports to the original CB Test Report can be issued to correct and/or include the following:

· applicant name/address changes;

· manufacturer name/address change;
· factory location name/address changes;
· changes in model/type designation;
· addition of the similar new models/types; - (if none or limited testing is required)
· changes/corrections to electrical rating; - (if none or limited testing is required)
· product modifications; - (if none or only limited testing is required)
· new/alternate components added; - (if none or only limited testing is required).

Note 1: There are two main reasons for issuing an Amendment Report, technical modifications to the
originally tested products (See IECEE 02, Clause 4.2.4) and corrections.

Note 2: Misprints and typo errors are treated as corrections. They are not considered a technical
modification to the product. Once corrections are processed client/applicant may simply replace the
affected pages in the original Test Report. (In order to be traceable, the corrections should have the date
of correction typed on the corrected page). There is no limit on the number of allowed corrections.

5.2. Number of changes allowed to the CB Test Report

5.2.1 It may be necessary to modify the information contained in a CB Test Report several times.
However, if these modifications are due to technical changes to the certified product(s) they are
limited to three, after which a new CB Test Report (and CB Test Certificate) shall be issued. This
shall not preclude issuing a new CB Test Reports and Certificates for every technical modification, if
the Member NCBs and the Applicant wish to do so.
Note: It is recommended, however, that for extensive product modifications requiring testing, a new
CB Test Report be issued, even if less than three technical modifications were previously processed.

5.2.2. Engineering judgment should be used regarding the issue of a new CB Test Report versus an
Amendment Report, however, upgrading a CB Test Certificate and Report from an old edition of the
standard to a newer edition of the standard requires issuing a new CB Test Certificate and a new CB
Test Report. The appropriate TRF, matching the new edition of the standard, shall be used. An
Amendment Report is not allowed in this case.

5.3. Identification of changes to CB Test Reports:

5.3.1. When a product is subject to technical modifications, both, the CB Test Certificate (under
"Additional Information") and CB Test Report (under “General product information”) shall clearly
identify the nature of such modifications, as applicable.

5.3.2. The following rules apply when issuing an Amendment to the original CB Test Report:

5.3.2.1. The reason for the issued Amendment Report shall be explained. All changes made
to the original Test Report shall be explained and conducted tests identified.

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Note: For example, if new models are being added, explain the differences and similarities
between models and indicate tests that were performed or why tests were not performed.

5.3.2.2. All clauses and/or sub-clauses of the original Test Report that are affected by the
changes should be appropriately revised. All pages included in the Amendment Report shall
be marked with the correct identifier (e.g. Report Ref. number and the date when the changes
to the original Test Report were made).

5.3.2.3. For illustration purposes, a few completed pages from an Amendment Report are
shown in Annex F. The example shows Amendment No. 2 Report issued due to the technical
modification to the product (critical components were added) with limited testing. However, the
original Test Report was already modified once by Amendment 1 Report, which has been
issued because new models were added. In this case, after engineering review of the
differences and similarities between originally tested models and new models, no tests were
considered necessary. In the provided example, the history of all changes and the reasons
why the Amendment Reports have been issued are clearly documented.
After one more technical modification to the product a new CB Test Report shell be issued.
The reissued Test Reports, construction review and the necessary testing shall be completed
(see also IECEE 02, Clause 6.3.4).

5.3.2.4 Each Amendment Report shall contain its own “General information section”, which
shall be reproduced from the original Report with the necessary changes. If applicable,
additional pages containing, revised clauses/sub-clauses and modified test tables for
conducted tests, and/or other pages (such as photos, schematics, manuals) that are affected
by the product modifications shall be appended.

5.4. Issuing a CBTC and CBTR over another CBTC

5.4.1. When issuing a CBTC over another CBTC (originally issued by NCB “1”)the following
conditions of recognition by the NCB “2” shall be followed and documented in the Test Report:
For NCB “2” to accept the CBTR/CBTC issued by NCB “1” for its own CB Certification, the Applicant
shall provide all relevant details obtained from NCB “1” for the CBTR/CBTC in question. The NCB “2”
shall arrange for:
• Obtaining a sample(s) and performing a construction review
• Performing any additional required testing, which will cover any new requirements (e.g. new edition
of a standard, national differences, etc.) or address and evaluate changes made to the product.
• Recording the necessary information in the new CB Test Report. The source of the original test
data from NCB “1” shall be identified in the new CB Test Report prepared under the
responsibility of NCB “2” (Based on ISO/IEC 17025, Sub-clause 4.13.2, “Technical records,”).

5.4.2. The information about the source of the original test data shall be provided in the section
“Summary of testing.” The date when sample was received for construction review shall be recorded
in the “Date of receipt of test item” field. Additional clarification may also be provided in the “General
Product Information section.”

Note 1: The extent of retesting or further partial testing, such as selected clauses of the relevant
standard(s), should be up to the professional judgment of NCB “2” as there can be various cases and
each case may require a particular approach.
Note 2: As a minimum, the product is required to go through a construction review and any further
partial testing deemed appropriate in the judgment of NCB “B” to fully cover any modifications to the
product or according to a new edition of a standard, National Differences, etc.
Note 3: Since some tests may influence the tests that follow, the sequence of tests must always be
considered.

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Part 6
Requests for modifications to TRFs

6.1. General

The use of the most recent TRF template is compulsory for all newly developed TRFs. Previously
prepared TRFs for standards that are frequently used by the CB Scheme shall also be updated using the
new template, however; there is no need for an immediate update of those TRFs that are infrequently
used, unless specifically requested by members.

6.2. Modifications required due to an updated TRF Template

6.2.1. Most of template modifications are administrative in nature and simply reflect new CMC
decisions. When the TRF template is modified, the IECEE Secretariat shall request the originators
of TRFs to incorporate these modifications within the specified time frame. If this is not practical,
the IECEE Secretariat shall allow non-originators to make the updates based on template changes
(See clause 6.2.3). In either case, the TRFs need to be formally re-distributed to members.

Note: The updates of TRFs may also be used by the IECEE Secretariat to remove from the list of
TRFs those forms that are obsolete and no longer in use. (See also clause 6.4).

6.2.2. When the originator is not able to provide the updated TRF in the a time frame requested by
the Secretariat, and there is an urgent need for the updated TRF, another member appointed by
the Secretariat can make the updates, however, the process shall be as follows:
- IECEE Secretariat always sends request to the originator after a new template is approved
by the CMC and specifies the time frame for completion of the updates
- If the originator is not able to make that update, the IECEE Secretariat follows clause
6.2.3 and the administrative update path in Annex G.

6.2.3. Rules for administrative TRF changes:

- No reimbursement for administrative modifications to the TRFs
- The originator remains the same, since this is an administrative update only unless
otherwise agreed with the IECEE Secretariat
- No technical changes to the TRF allowed when update is based on a new template
- New TRF version (suffix letter) is assigned
- Distribution according to Annex G (all correspondence with a copy to the originator)

Note: - In special cases, administrative changes may be combined with technical changes when
agreed with the TRF originator and the IECEE Secretariat. For the correct procedure see
clause 6.3.

6.3. Requests for technical modifications to published TRFs

Request for technical modifications shall be according to the flowchart in Annex G.

6.3.1. After a new TRF has been developed, the TRF is published on the IECEE website and
considered “under comments”.

6.3.2. The comment period is maximum 6 months depending on the complexity of the TRF and
based on originator’s recommendation. All comments are to be sent to the IECEE Secretariat
using Annex I modification form.

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6.3.3. During the comment period all members can use the TRF without restrictions, however; all
users shall be prepared to replace the TRF in their system, should the TRF be modified due to
comments received from members and incorporated in the TRF.

6.3.4. Following the 6-months comment period, the originator shall incorporate received comments
in the TRF. In case the provided comments cannot be included, the originator informs members
and provides an explanation. In case of a disagreement, members can appeal to WG 9 and ETF,
as appropriate. See flowchart in Annex G for details.

Note: TRF modification request form is not required when only minor and obvious corrections are
needed. The use of the form is recommended when many changes are necessary. However, in all
cases, the form helps tracking the implementation of modification requests.

6.3.5. After the modifications/comments provided by members have been incorporated in the TRF,
the TRF is considered a “final form.” Normally, no additional changes are allowed at this stage
(exception: only critical issues accidentally overlooked during the 6 months comment period can be
processed).

6.3.6. CB Test Certificates issued in conjunction with Test Reports based on the preliminary
version of TRFs shall be accepted as equivalent to the certificates provided with the final version of
the TRFs.

6.3.7. The “Master TRF date” shall be the TRF publication date. The publication date will be
different for the TRFs published on the IECEE website “under comments” and the final version
TRFs. Once the TRF is finalized, the publication date is replaced with the new date, which
designates the final version.

6.4. Simplified procedure for TRF distribution

The simplified TRF distribution procedure is used when either only the administrative changes to
the TRF are made or when TRF updates are due to a simple Amendment to IEC standard. The
main difference between the regular and simplified distribution procedure is the 6-months trail and
comment period. In case of the simplified TRF distribution procedure, the TRF is immediately
published as the final TRF. The TRF originator shall advise the IECEE Secretariat whether the
simplified TRF distribution process is applicable. See also Annex G.

6.5. Updates of the IECEE list of TRFs

Only TRFs that are based on standard editions currently in the scope of the CB Scheme shall
remain on the IECEE list of TRFs.

Old versions of the TRFs shall be identified as archived on the IECEE Website. Allowing access to
old versions of TRFs is for reference only (due to previously issued CB Test Reports that may be
still valid in some countries). The archived TRFs shall not be used to generate new Test Reports.

TRFs shall be moved to the archives according to the rule that if there are less than three (3)
members using the old edition of the standard, the IEC standard is no longer operational in the CB
Scheme.

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Annex A
Helpful hints for TRF originators:

1. In order to add an automatic update for all fields containing the same information, for example
the Report Ref. Number, follow these instructions:
Select View, Toolbars, Forms

Move cursor into the space for Report Reference No. on the first page of the Test Report.
Then click on Text Form Field icon (ab). Select shading for easier identification of this new field.

Double click on the newly created Text Form Field to open the Text Form Field screen:

Type Bookmark name CP1 (use name CP1 for the Report Reference No. for consistency).
Type Report Ref. No. in the “default text field” and click OK.

Move cursor to any space where normally the Report Reference No. should be typed (normally
in the header).

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Annex A

Select Insert, Field, Links and References and Ref. Then type CP1 and click OK.
If you have several sections with different headers and page layout in the TRF you may need to
repeat these steps for each section.

To use the update field feature go to the Text Form Field. Double click on the field, type the
information (such as Report Ref. No.) in the “default text field” and click OK.

On each page of the printed document MS Word will automatically enter the text from the
“default text field” into the selected locations with the REF CP1 identification.

2. In order to add a dotted leader for test cases requiring a specific result or comment in
addition to the verdict, follow these instructions:

Cl. Requirement - Test Result Verdict

20.5 Length  10 m .........................................: 12,5 Pass

Move cursor to the second cell (“Requirement – Test”) and click Format then select Tabs.

In the “Tab stop position” type 6.7 cm (or as appropriate for the size of the table).
Set the alignment on “left”. Select the leader No. 2. Click on “Set” and then OK.

While still in the second cell, move cursor to the end of text in this cell and press “Control” +
“Tab”. Add the “:” symbol.

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Annex A

3. In order to add shading in the cell, place cursor in that cell; select Format, Borders and
Shading. Click on the “Shading” tab and choose the top square for the 12.5% Grey.
You may also select Patterns, Style and 12.5% for the shading. This method appears to work
better during the conversion from MS Word 6.0 to higher versions of MS Word (the shading is
not lost).

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Annex B

Checklist for TRF Originators

No. Requirem ent Result

1 Forma tting of the TRF
1a Was the latest TRF template used? Was the IECEE Website consulted?
1b Are margins set as Top 2 cm, Bottom 2 cm, Left 3 cm, Right 1 cm and paper
size set to A4 (210 x 297 mm)?
1c Are normal text Arial 10 pt (True Type) font, special characters (e.g. °, β, Ω)
and Symbol (True Type) used?
1d Is MS Word format "97-2002 + 6.0/95 - RTF" used?
1e Is full name of the TRF originator provided?
1f Is correct copyright text and current year entered on the first page?
1g Does the TR form include no macros, except for the Test Report Ref. Number
and the page numbers?
2 TRF structure
2a Is the IEC standards number and edition entered correctly?
2b Is correct TRF number entered the footer of each TRF section?
2c Is correct standard number entered in the header?
2d Does the section titled “Test items particulars” provide information about the
product, which is necessary to establish the correct test program (such as
special features and characteristics of the product)?
2e Does the TRF include all required TRF sections?
2f Is Component Table placed at the end of the TRF?
2g Is section covering National Differences included, when available?
2h Are the different test case types properly used in the TRF?
2i Are all pages of each section in the Test Report provided with page number
and with the total of pages indicated? Is the page numbering macro working
properly?
2j Is the number of sub-headers in a sequence (sub-headers following each other
without any regular test case entries in-between) avoided and kept to
minimum?
3 Com ments and verdicts
3a Is the column titled “Requirement – Test” a summary of the requirement and
not a repeated full text of the standard?
3b Are indicative rather than imperative phrases used when abbreviating the
requirements?
3c Are words such as “shall” and “should” avoided in the TRF?

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3d Is each requirement in the “Requirement – Test” column worded in such a way

that it prompts for a clear “Pass”, “Fail” or “N/A” verdict?
3e Are regular test cases requiring a specific result or comment in addition to the
verdict indicated by a dotted leader?
3f Are shaded verdict field identifying only the auxiliary test cases, which do not
require a verdict but only additional information?
3g For measured values to be recorded in the tables and the main part of the TRF
are units of measurement indicated?
4G eneral
4a Was spelling checked?
4b Was correct language set?
4c Was the use of simplified distribution procedure (Annex G) considered?

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Annex C

Example of a blank Test Report Form

and National Differences Form

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Test Report issued under the responsibility of:

TEST REPORT
IEC 60601–2–33
Medical electrical equipment
Part 2: Particular requirements for the safety of magnetic resonance equipment for medical
diagnosis

Report Reference No..................... :

Date of issue ................................... :
Total number of pages .................... :

CB Testing Laboratory.................. :
Address........................................... :

Applicant’s name .......................... :

Address........................................... :

Test specification:
Standard ......................................... : IEC 60601-2-33: 2007 (Second Edition) + A 1: 2005 + A 2: 2007
for use with IEC 60601-1:1988 + A1:1991 + A2: 1995
Test procedure ................................ : CB Scheme
Non-standard test method…………..: N/A
Test Report Form No..................... : IEC60601_2_33F
Test Report Form(s) Originator ....... : Underwriters Laboratories Inc.
Master TRF ..................................... : Dated 2009-05
Copyright © 2009 IEC System for Conformity Testing and Certification of Electrical Equipment
(IECEE), Geneva, Switzerland. All rights reserved.
This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as
copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from
the reader's interpretation of the reproduced material due to its placement and context.
If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo and the reference to the CB
Scheme procedure shall be removed.
This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory
and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02.
Test item description .................... :
Trade Mark...................................... :
Manufacturer ................................... :
Model/Type reference ..................... :
Ratings............................................ :

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Page 2 of 7 Report No. ___

Testing procedure and testing location:

CB/CCA Testing Laboratory:
Testing location/ address ......................:

Associated CB Laboratory:
Testing location/ address ......................:

Tested by (name + signature) .....:

Approved by (name + signature) .:
Testing procedure: TMP
Tested by (name + signature) .....:
Approved by (name + signature) ..:
Testing location/ address ......................:

Testing procedure: WMT

Tested by (name + signature) .....:
Witnessed by (name + signature).:
Approved by (name + signature) .:
Testing location/ address ......................:

Testing procedure: SMT

Tested by (name + signature) .....:
Approved by (name + signature) ..:
Supervised by (name + signature):
Testing location/ address ..................... :

Testing procedure: RMT

Tested by (name + signature) .....:
Approved by (name + signature) ..:
Supervised by (name + signature):
Testing location/ address ......................:

TRF No.: IEC60601_2_33F

Note 1: In the example above, the Testing Laboratory marked testing procedure and location as CBTL
and TMP. In this case only the signature fields that are relevant for testing at the CBTL and TMP are
required.

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Page 3 of 7 Report No. ___

List of Attachments (including a total number of pages in each attachment):

Summary of testing:

Tests performed (name of test and test clause): Testing location:

Summary of compliance with National Differences

List of countries addressed:

The product fulfils the requirements of _________ (insert standard number and edition and delete the
text in parenthesis or delete the whole sentence if not applicable).

Copy of marking plate:

“The artwork below may be only a draft. The use of certification marks on a product must be authorized by
the respective NCBs that own these marks”

TRF No.: IEC60601_2_33F

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Test item particulars................................................. :

FIRST LEVEL CONTROLLED OPERATING MODE capability :
SECOND LEVEL CONTROLLED OPERATING MODE
capability.................................................................. :
Equipped with superconducting magnets ................ :
Equipped with resistive magnets.............................. :
Type of gradient system .......................................... :
Options included ...................................................... :
.................................................................................... :
Possible test case verdicts:
- test case does not apply to the test object ................ : N/A
- test object does meet the requirement ...................... : P (Pass)
- test object does not meet the requirement ................ : F (Fail)
Testing ........................................................................ :
Date of receipt of test item........................................... :
Date (s) of performance of tests .................................. :

General remarks:
The test results presented in this report relate only to the object tested.
This report shall not be reproduced, except in full, without the written approval of the Issuing testing
laboratory.
"(see Enclosure #)" refers to additional information appended to the report.
"(See appended table)" refers to a table appended to the report.

Throughout this report, a point (comma) is used as the decimal separator.

This Test Report Form is intended for the investigation of magnetic resonance equipment for medical
diagnosis in accordance with IEC 60601-2-33. It can only be used together with IEC 60601-1 Report.
Throughout this report a comma / point is used as the decimal separator.

Manufacturer’s Declaration per Sub-clause 6.2.5 of IECEE 02:

The application for obtaining a CB Test Certificate Yes/Not applicable
includes more than one factory location and a
declaration from the Manufacturer stating that the
sample(s) submitted for evaluation is (are)
representative of the products from each factory has
been provided .............................................................. :

When differences exist; they shall be identified in the General Product Information section.
Name and address of factory (ies) ......................... :

General product information:

TRF No.: IEC60601_2_33F

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IEC 60601-2-33
Clause Requirement + Test Result - Remark Verdict

6 IDENTIFICATION, MARKING AND DOCUMENTS

6.8.1 ACCOMPANYING DOCUMENTS provide sufficient
information to the USER
6.8.2 aa) INSTRUCTIONS FOR USE provide recommendations See Attachment #
for and indicate the need for a pre-screening
program to identify PATIENTS and MR WORKERS at risk
- provide recommendations to adequately safeguard
PATIENTS and MR WORKERS from injury taking into
consideration risk due to past professional activity
which might have caused accidental implantation of
ferromagnetic materials for MR WORKER
All three specific classes of PATIENTS are mentioned
in the INSTRUCTIONS FOR USE
bb) INSTRUCTIONS FOR USE provide clear
recommendations to the USER to establish a program
for the supervision appropriate to the classes of
PATIENTS described in 6.8.2 aa) and to the controlled
mass of operation of the MR EQUIPMENT
Note: Remaining sub-clauses from Clause 6 were removed to save space in this OD.

26 VIBRATION AND NOISE

The MR EQUIPMENT does not produce noise having See appended Table 26
an unweighted peak sound pressure level (Lp) higher
than 140 dB referenced to 20 Pa in any accessible
area........................................................................... :

36 ELECTROMAGNETIC COMPATIBILITY
Outside the CONTROLLED ACCESS AREA the magnetic
stray field is smaller than 0.5 mT and the
electromagnetic interference level complies with
Collateral Standard IEC 60601-1-2
Inside the CONTROLLED ACCESS AREA the
requirements as stated in 6.8.2 ee) were applicable

45 PRESSURE VESSELS AND PARTS SUBJECT TO PRESSURE

45.101 The helium vessel is designed as a pressure vessel
and was tested in compliance with clause 45 of
IEC 60601-1, or with national regulations................. :

TRF No.: IEC60601_2_33F

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49 INTERRUPTION OF THE POWER SUPPLY

49.101 The MR EQUIPMENT comprises a superconducting
magnet or resistive magnet and is provided with an
EMERGENCY SHUT DOWN UNIT

49.102 The equipment is provided with a facility to allow the

OPERATOR to immediately stop a scan by interrupting
the power to the gradient system and that to the RF
transmit coil as required

51 PROTECTION AGAINST HAZARDOUS OUTPUT

51.101 Operating modes
51.101.1 The MR EQUIPMENT complies with the requirements in
sub-clauses from a) to c):
a) Means are provided in order to ensure, that the
limit(s) of the selected operating mode cannot be
exceeded. This control is independent of OPERATOR
input or is checked by the MR EQUIPMENT in order to
detect any OPERATOR input error
b) A reset to the NORMAL OPERATING MODE with
respect to SAR and dB/dt is performed automatically
with change of the PATIENT
c) The MR EQUIPMENT provides information upon
request about the relevant SAR and relevant
GRADIENT OUTPUT ...................................................... :

Note: Remaining sub-clauses from Clause 51 were removed to save space in this OD.

52 ABNORMAL OPERATION AND FAULT CONDITIONS

52.1 Safety of the MR EQUIPMENT was assessed against
the requirements of clause 52 in the Collateral
Standard IEC 60601-1-4
All relevant information regarding residual risk is
included in the INSTRUCTIONS FOR USE
Means are provided to secure the software and
firmware control programs against unauthorised
access or modification

59 CONSTRUCTION AND LAYOUT

59.101 MR equipment equipped with a superconducting
magnet, has means to monitor the cryogen level(s)

TRF No.: IEC60601_2_33F

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Clause Requirement + Test Result - Remark Verdict

26 TABLE: measurements of acoustic noise

Location of the microphone..................................................................... :
MR EQUIPMET mode producing the worst case situation acoustically...... :
Accessible area Measured unweighted Measure A-weighted Remarks
peak sound pressure r.m.s. sound pressure
level Lp (dB) level LAeq, 1 h (dB)

Supplementary information:

51.105.2 TABLE: measurements of maximum GRADIENT OUTPUT for PATIENT

Dimensions of the compliance volume (m)…….….………………..:
Coordinates the compliance volume boundaries (m)……………...:
MAXIMUM GRADIENT SLEW RATE per GRADIENT UNIT (mT/m/ms)……:
SEARCH COIL sensitivity factor S………………………………………:
GRADIENT Max. Max. Ramp Coordinates Peak value GRADIENT Remarks
UNIT GRADIENT GRADIENT time of location Vout of OUTPUT
strength G+,max strength G-,max (ms) (m) SEARCH COIL dB/dt (T/s)
(mT/m) (mT/m) voltage (V)

Supplementary information:

TRF No.: IEC60601_2_33F

Note 2: This is an example and only selected pages from the TRF were copied.

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ATTACHMENT No. _____ Page 1 of 1 Report No. ___

List of test equipment used at the TMP Laboratory

Clause Measurement / Testing / measuring Range used Last Calibration Calibration

testing equipment / material used date due date
(Equipment ID)

Note 3: The TMP procedure was used and the list of test equipment is required.

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IEC60601_2_22C - ATTACHMENT
Clause Requirement + Test Result - Remark Verdict

ATTACHMENT TO TEST REPORT IEC 60601-2-22

EUROPEAN GROUP DIFFERENCES AND NATIONAL DIFFERENCES
(Medical electrical equipment, diagnostic and therapeutic laser equipment)
Differences according to............... : IEC 60601-2-22: 2007 (Third Edition) for use in conjunction with
IEC 60601-1: 2005 (Third Edition)
Attachment Form No..................... : EU_GD_IEC60601_2_22C
Attachment Originator .................. : Name of originator
Master Attachment ........................ : date
Copyright © 2008 IEC System for Conformity Testing and Certification of Electrical Equipment
(IECEE), Geneva, Switzerland. All rights reserved.

CENELEC COMMON MODIFICATIONS (EN 60601-2-22)

ZB ANNEX ZB, SPECIAL NATIONAL CONDITIONS (EN 60601-2-22)

ZC ANNEX ZC, NATIONAL DEVIATIONS (EN 60601-2-22)

Note 4: This is an example only, not an actual TRF for National Differences.

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Page 1 of x Report No.:

IEC60601_2_22C - ATTACHMENT
Clause Requirement + Test Result - Remark Verdict

ATTACHMENT TO TEST REPORT IEC 60601-2-22

US NATIONAL DIFFERENCES
Medical electrical equipment
Part 22: Particular requirements for safety of diagnostic and therapeutic laser equipment
Differences according to............... : IEC 60601-2-22
Attachment Form No..................... : US_ND _IEC60601_2_22C
Attachment Originator .................. : Name of originator
Master Attachment ........................ : date
Copyright © 2008 IEC System for Conformity Testing and Certification of Electrical Equipment
(IECEE), Geneva, Switzerland. All rights reserved.

National Differences

Special national conditions (if any)

Note 5: This is an example only, not an actual TRF for National Differences.

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Annex D

Example of a TRF page in landscape orientation

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Annex D
Page 30 of 35 Report No.

IEC 60xxx-2-1
Clause Requirement - Test Result - Remark Verdict

10A TABLE: flammability test for classifying materials 5V

Sample test bars test plaques
No./ref. thickness (mm) flaming time (s) burning distance (mm) thickness (mm) position flaming & glowing time (s) burning distance (mm)

Supplementary information:

TRF No.: IEC60xxxA

Note: This is an example only, not an actual TRF.

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Annex E

Instructions on how to complete Test Report pages

Annex E comprise the following subsections:

CONTENTS Page

TRF Cover Page 42

Testing procedure and testing location 44
List of attachments 45
Summary of testing 45
Summary of compliance with National Differences 45
Copy of marking plate 45
Test items particulars 45
Possible test case verdicts 46
Testing dates 46
General remarks 46
Manufacturer’s Declaration 46
Name and address of factory(ies) 46
General product information 47

Different test cases & clause types require different type of input 48
Component Information 50
Test Measurement section 51
National Differences 53
Additional Options 54
List of test equipment used 55

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Annex E

TRF Cover Page

Note1: Cover page example based on TRF for IEC 60601-1-6
_________________________________________________________________________________

IEC 60601 - 1- 6
Medical electrical equipment
Part 1-6: General requirements for safety - Collateral Standard: Usability

Report Reference No: Type Test Report reference number

Date of issue: Type Test Report issue date
Total number of pages: Macro or type number of pages

CB Testing Laboratory: Type name of responsible Testing Laboratory

Address: Type address of Testing Laboratory

Applicant’s name: Type name of Applicant

Address: Type Applicant’s address

Test specification: Do not modify standard(s) identified by the TRF Originator

Make sure to select the TRF corresponding to the edition of the standard (including Amendments)
that was used for the investigation of the product.
Standard : IEC 60601 1-6: 2006, Second Edition
Test procedure : CB Scheme
(Remove reference to the CB Scheme if not issuing a CB Test Certificate according to IECEE 02).
Non-standard test method: N/A
Describe any non-standard test methods used or type N/A.

Note 2: When it is necessary to use methods not covered by standard methods, these shall be
documented according to ISO/IEC 17025:2005, Clause 5.4.4..

Test Report Form No. : IEC60601_1_6B (Not to be modified)

Test Report Form Originator : Not to be modified
Master TRF : Dated 2008-01 (Not to be modified)
Copyright © 2008 Worldwide System for Conformity Testing and Certification of Electrotechnical
Equipment and Components (IECEE), Geneva, Switzerland. All rights reserved.
This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as
copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from
the reader's interpretation of the reproduced material due to its placement and context.

If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo and the reference to the CB
Scheme procedure shall be removed.
This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory
and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02.

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Annex E

Note 3: The copyright text and additional information is a standard text and shall not be modified or
removed from the TRF.)

Test item description : Describe the product (computer, modem, hand-held lamp,
electric oven, …...)
Trademark : Describe or paste a copy of the trademark used

Manufacturer : Type name and address of the manufacturer

(See IECEE 02, Clause 3.7)
Model/type reference : Type, model, type reference as it appears on the marking plate

Rating(s) : Provide rating values corresponding to the ratings on which

the testing has been based and as identified on the marking
plate.

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Annex E
Testing procedure and testing location:

Select applicable program and identify testing location.

CB Testing Laboratory : Type name of the Main Testing Laboratory

Testing location/ address : Type address of the Main Testing Laboratory

Associated Laboratory : Type name of ACB Testing Laboratory

Testing location/ address : Type address of Associated Laboratory
Tested by (name + signature) : Type name Sign here
Approved by (name + signature) : Type name Sign here

Note 4: An Associated CB Testing Laboratory is a testing facility that has a limited testing capability within its
recognized scope of specific Product Categories or standards, and may need to rely upon the Main CBTL, with which
it is associated, to handle tests outside its limited capabilities. A qualified staff of the Main CBTL is responsible for
carrying out a review of test reports and/or partial test reports prepared by the Associated CB Testing Laboratory for
which it is responsible. See OD-2015, Clauses 2.2 and 3.2.
________________________________________________________________
When TPM Procedure used:
Testing procedure: TMP : Type name of TMP Laboratory
Tested by (name + signature) : Type name (CBTL) Sign here
Approved by (name + signature) : Type name (CBTL or NCB) Sign here
Testing location/ address : Type address of TMP Laboratory
________________________________________________________________
When WMT Procedure used:
Testing procedure: WMT : Type name of WMT Laboratory
Tested by (name + signature) : Type name (WMT) Sign here
Witnessed by (name + signature) : Type name (CBTL or NCB) Sign here
Approved by (name + signature) : Type name (CBTL or NCB) Sign here
Testing location/ address : Type address of WMT Laboratory
________________________________________________________________
When SMT Procedure used:
Testing procedure: SMT : Type name of SMT Laboratory
Tested by (name + signature) : Type name (SMT) Sign here
Approved by (name + signature) : Type name (SMT) Sign here
Supervised by (name + signature): Type name (CBTL or NCB) Sign here
Testing location/ address : Type address of SMT Laboratory
________________________________________________________________
When RMT Procedure used:
Testing procedure: RMT : Type name of RMT Laboratory
Tested by (name + signature) : Type name (RMT) Sign here
Approved by (name + signature) : Type name (RMT) Sign here
Supervised by (name + signature) Type name (NCB) Sign here
Testing location/ address : Type address of RMT Laboratory
________________________________________________________________

Note 5: All blank Test Report Forms contain all programs and signature fields for:
(1) “Tested by”; (2) “: Supervised by”; (3) “Witnessed by”; and (4) “Approved by” as required by the CB Operational
Documents (OD-2027, -2028, -2029, -2030, -2031).

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Annex E
List of attachments:
The list below includes typical examples of attachments:
a) Photo (x pages) - required
b) National Differences (xx pages) – when applicable
c) List of test equipment (xx pages) – required when TMP or WMT programs are used
d) Other attachments as needed
List of Attachments shall include a total number of pages in each attachment.

Summary of testing:
Provide list of tests performed (name of the test and test clause number), as applicable.
Provide information on testing location.
The “Summary of testing” field shall contain the list of all tests conducted by the CBTL or MTL
according to the testing program agreed with the responsible NCB.

The reason why any of the normally applicable tests were not conducted shall be explained in the
“General product information“ field.
It is important to clarify the differences between models covered by the Report when testing a family
(series) of products.
Summary of compliance with National Differences:
Provide list of countries, for which compliance with National Differences has been verified. Include
any additional relevant information in the National Differences TRF included in the CB Test Report.
Copy of marking plate:
Include a copy of the marking plate showing model designation, rating, manufacturer, and other
information, as appropriate and/or required by the standard.

If the marking plate artwork contains certification marks, the use of these certification marks on the
actual product must be authorized by the respective NCBs. The following statement shall be included
in the “Copy of marking plate” field of the Test Report:
“The artwork below may be only a draft. The use of certification marks on a product must be
authorized by the respective NCBs that own these marks”
Test items particulars:
Provide information about the product needed to establish a correct test program, such as product
mobility, type of power connections, and similar.
Select information applicable to the product, add values provided in technical documentation.
Example:

Test item particulars................................................. :

Classification of installation and use........................... : See IEC 60601-1 Test Report
Mode of operation....................................................... : Intermediate
Surface temperature of APPLIED PART ......................... : 40ºC

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Annex E
Possible test case verdicts:

Test case does not apply to the test object: N/A

Test item does meet the requirement: Pass (P)
Test item does not meet the requirement: Fail (F)

Note 6: The verdict may be spelled out (Pass, Fail) or abbreviated (P, F).

Testing dates:
Date of receipt of test item : Complete as appropriate (YYYY-MM-DD)
Date(s) of performance of test : Complete as appropriate and when required by
the test procedure used.

Note 7: Date(s) of performance of test may be a time frame from – to or the last day of testing.

General remarks:
The text below shall not be modified, except as noted.

The test results presented in this report relate only to the item(s) tested.
This report shall not be reproduced except in full without the written approval of the testing laboratory.

Clause numbers between brackets refer to clauses in EN 60598-1 (optional remark for EN
standards).
(see remark #)" refers to a remark appended to the report.
"(see Annex #)" refers to an annex appended to the report.
"(see appended table)" refers to a table in the Test Report.

When using a comma or point as the decimal separator in data entered in the Test Report, select as
appropriate:

Throughout this report a comma / point is used as the decimal separator.

Manufacturer’s Declaration (per Sub-clause 6.2.5 of IECEE 02):

When the application for obtaining a CB Test Certificate includes more than one factory location, the
Applicant shall include a declaration from the Manufacturer(s) stating that the sample(s) submitted for
evaluation is (are) representative of the products from each factory (Sub-clause 6.2.5, IECEE 02).

Name and address of factory(ies):

The CB Test Report shall include the name and address of each factory.

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Annex E

General product information:

(Optional)

Provide product information, intended use, explanation of the test program, model differences, and similar
information, as needed.

Provide the rationale for selection of samples for testing, when applicable.

Note 8: It is not necessary to explain sample selection, when sample selection is already addressed by
the standard.

Additional examples of information that may be included in this field:

1. The reason why any of the applicable tests were not conducted shall be explained.

2. Definition of variables used in the type/model designation

For new Test Reports the following may be useful:

Detailed product information;

Type of product;
Intended user (if prior training is necessary);
Intended operating environment (if different from normal/typical as defined by the standard);
Readiness for use (end product, sub-assembly or component);
Accessories;
Modules and interconnection (if equipment under test is of a modular design);
Other aspects as highlighted by the corresponding standard.

For modifications to the existing Test Reports the following may be useful:

Clear explanation of the nature of such modifications as required by clause 5.2;

Identification of product changes, preferably in comparison to the original model tested.

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Annex E

Different test cases and clause types require different type of input:

Types of Clause in a TRF:

Heading:

Cl. Requirement - Test Result Verdict

Verdict
30. CONSTRUCTION optional

Verdict recommended but can be omitted when all verdicts in related sub-clauses are provided.

Sub-heading:

Cl. Requirement - Test Result Verdict

Verdict
10.5 Markings for Class II appliances: required

Test case types:

Regular test cases

Cl. Requirement - Test Result Verdict

Result/comment optional Verdict
21.1.1 Marking on main part required

When regular test case requires a specific result or comment in addition to the verdict, it is indicated by a
dotted leader as in the example below. In this case both, the comment (or measured value) and verdict
are required.

Cl. Requirement - Test Result Verdict

Result/comment required Verdict
20.5 Length  10 m....................................... : required

A shaded verdict field identifies Auxiliary test case, not requiring a verdict but additional information only.
In this case the verdict is not needed only the result shall be provided.

Cl. Requirement - Test Result Verdict

3.2.1 Test temperature (°C) .......................... : Result/comment required 

Note 9: Example of completed clauses from the TRF for IEC 60950-1)

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Annex E

4 PHYSICAL REQUIREMENTS
4.1 Stability Pass
Angle of 10 Test sample did not fall over Pass
Test: force (N)..................................................... : 200 N Pass

4.6 Openings in enclosures Pass

4.6.1 Top and side openings Pass
Dimensions (mm) .............................................. : Openings do not exceed 3 mm 
in any dimension
4.6.2 Bottoms of fire enclosures Pass
Construction of the bottom ................................. : Openings in the bottom are 
protected by a screen
4.6.3 Doors or covers in fire enclosures The door is interlocked Pass
4.6.4 Openings in transportable equipment N/A
4.6.5 Adhesives for constructional purposes N/A
Conditioning temperature (C)/time (weeks) ...... : N/A 

5 ELECTRICAL REQUIREMENTS AND SIMULATED ABNORMAL CONDITIONS

5.1 Touch current and protective conductor current Pass
5.1.1 General Pass
5.1.2 Equipment under test (EUT) Pass
5.1.3 Test circuit Pass
5.1.4 Application of measuring instrument Pass
5.1.5 Test procedure Pass
5.1.6 Test measurements Pass
Test voltage (V) ................................................: 1500 V 
Measured touch current (mA) ...........................: 0.3 mA 
Max. allowed touch current (mA) ......................: 3.5 mA 
Measured protective conductor current (mA) ....: 20 mA 
Max. allowed protective conductor current (mA) : N/A 

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Annex E
Component information:

Note 10: Example of completed Critical Component table

TABLE: Critical components information Pass

Object / part No. Manufacturer/ Type / model Technical data Standard Mark(s) of
trademark conformity1)
AC Inlet Makao Enterprise MA-224 250 V ac, 2.5 A IEC 60320-1 VDE
Ltd. UL Recognized
Fuse (F1) Fusecom Co. F-240S T2A, 250 V IEC 60127-1 VDE
IEC 60127-3 UL Recognized
Fuse Holder Fusehod Co. F-240SAP 10 A, 250 V IEC 60127-6 CSA
UL Recognized
- Description Secured through the double “D” shaped hole in the enclosure by a lock washer and a nut
Enclosure GE Plastics Designated V-1, 105ºC, UL 94 UL
SE1 2.5 mm thick
X-Capacitor Darin Co. Ltd MPX2 0.33μF, 275V, IEC 60384-14 VDE
(CX3) 100ºC
Line Filter (LF1) Wells Industry Ltd HNN-B1 300 V, 130ºC - -
Triple insulation Furukawa Co. TEX-E2 130ºC IEC 60950-1 VDE
wire used in LF1 See license UL
attached
Transformer T1 Wells Industry Ltd HNN-2 300 V, 130ºC IEC 60950-1 TUV Rh
Bobbin of T1 Chang Plastics Co. Designated 7- Nylon, V-0, 150ºC UL 94 UL
37
Switch S1 Astronam Ltd. LPPD-33 300 V, 2.5 A IEC 61058-1 KEMA
- Description Single throw, double pole switch used as main disconnect device
Number of operations 10,000; contact gap 4 mm

Supplementary information:
1)
Provided evidence ensures the agreed level of compliance. See OD-2039.

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Annex E
Test Measurement section
(Tables, specific test conditions, test remarks and additional information)

Measured values shall be recorded in the tables.

2.10.3 and TABLE: Clearance and creepage distance measurements

2.10.4
Clearance (cl) and U peak U r.m.s. Required cl cl Required cr
creepage distance (cr) (V) (V) (mm) (mm) cr (mm) (mm)
at/of/between:
Functional:
350 V 230 V 1.5 2.0 2.5 2.7
Basic/supplementary:

Reinforced:

Supplementary information:

Note 11: It is not allowed to use statements such as “OK”, “meets the standard”, “more than”, “less than”,
or similar instead of the measured value unless otherwise specified by CTL.

5.1 TABLE: temperature rise measurements Pass

Test voltage (V) ................................................ : 190 
t1 (C) ............................................................... : 25 
t2 (C) ............................................................... : 26 
Temperature rise T of part/at: T (K) Allowed T (K)
Fuse holder 55 65
Terminal 30 55

Temperature rise T of winding: R1 () R2 () T (K) Allowed T Insulation

(K) class

Supplementary information:
Heating Test conducted in an enclosure sized 4 by 3 by 12 cm.

Note 12: The supplementary information field is provided for describing any specific test conditions or
testing clarifications.

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19.7 TABLE: Abnormal operation, locked rotor/moving parts

Test voltage (V)........................................................ : 220/120 
Ambient, t1 (°C) ........................................................ : 22/30 
Ambient, t2 (°C) ........................................................ : 24/30 
Temperature of winding R1 (Ω) R2 (Ω) dT (K) T (°C) Max. T (°C)

Winding (1) - Model 234 0.097 0.127 77.34 101.34 105

Winding (1) - Model 4566 0.108 0.153 110.21 140.21 155
Winding (2) - Model 234
Winding (2) - Model 4566

Model 234
Winding (1) 0.142 0.196 80.75 101.75 105
Winding (2)
Model 4566
Winding (1) 0.108 0.153 110.21 140.21 155
Winding (2)

Supplementary information
Motor Model 234 tested at 220 V and in the range of ambient temperature of 22ºC-24ºC
Motor Model 4566 tested at 120 V and at 30ºC

Note 13: Two examples that ensure traceability of measurements when completing a measurement table
for multiple models are shown above.

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Annex E
National Differences
(Section contains information and test results according to declared national differences).

Note 14: Provided example, based on the standard EN 60598-2-10, 2003 Edition, shows
Group/CENELEC Common Differences.

ANNEX TO TEST REPORT IEC 60598-2-10

EUROPEAN GROUP DIFFERENCES AND NATIONAL DIFFERENCES
Luminaries
Part 2: Particular requirements: Section Ten – Portable luminaries for children
Differences according.................... : EN 60598-2-10:2003 used in conjunction with
EN 60598-1:2004+A1:2006
Annex Form No. ............................. : EU_GD_IEC60598_2_10B
Annex Form Originator .................... : Intertek Semko AB
Master Annex Form ......................... : 2007-10
Copyright © 2007 IEC System for Conformity Testing and Certification of Electrical Equipment
(IECEE), Geneva, Switzerland. All rights reserved.

Clause Requirement + Test Result - Remark Verdict

CENELEC COMMON MODIFICATIONS (EN 60598-2-10) Pass

10.5 (3) MARKING Pass
10.5 (3.3.101) Adequate warning on the package Pass
10.10 (5) EXTERNAL AND INTERNAL WIRING Pass
10.10 (5.2.1) Connecting leads Pass
- without a means for connection to the supply N/A
- terminal block specified Pass
- relevant information provided Pass
- compliance with 4.6, 4.7.1, 4.7.2, 4.10.1, 11.2, Pass
12 and 13.2 of Part 1
10.10 (5.2.2) Cables equal to HD21 S2 or HD22 S2 Pass

ZB ANNEX ZB, SPECIAL NATIONAL CONDITIONS (EN) Pass

(3.3) DK: power supply cord with label Pass
IT: warning label on Class 0 luminaries N/A
(4.5.1) DK: socket-outlets Pass
(5.2.1) CY, DK, FI, SE, GB: type of plug Pass

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Annex E
Additional options:

When completing the Test Report for a product for which the whole chapter of the standard is not
applicable due to the nature of the product then, as an option, only the chapter’s header may be printed in
the final Report. (For example, modems and electric pencil sharpeners fall under the scope IEC 60950.
The telecommunication requirements apply to a modem but are irrelevant for electric pencil sharpener.)
________________________________________________________________________________

For pencil sharpener the Test Report may look as in the example below:

IEC 60950
Clause Requirement + Test Result - Remark Verdict

6 CONNECTION TO TELECOMMUNICATION NETWORKS N/A

Note 15: Example based on the TRF for IEC 60950, Third edition. Clauses 6.1 through 6.3 are not
printed.

For additional clarity, the header may also be followed by a supplementary note.

6 CONNECTION TO TELECOMMUNICATION NETWORKS N/A

Telecommunication requirements not applicable to the evaluated product. ―

If this time and paper saving option of compiling the TRF is selected, then the header with the N/A verdict
is always required. This is to indicate that the chapter was considered during the investigation but was
found to be not applicable. The printed header shows that the chapter was not accidentally omitted in the
final Test Report.

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Annex E
List of test equipment used:

A completed list of used test equipment shall be provided in the Test Reports when a Manufacturer
Testing Laboratory according to TMP or WMT procedures has been used.

Note 16: The list of test equipment is optional for SMTL and RMTL where quality system, verified by the
NCB during the assessment, ensures appropriate document control system in place.
Other forms with a different layout but containing corresponding information are also acceptable.

Testing / measuring
Measurement / Last Calibration Calibration
Clause equipment / material used,
testing Range used date due date
(Equipment ID)

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Annex F
Example of Amendment to the original Test Report

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 Annex F

Test Report issued under the responsibility of:

TEST REPORT
IEC 60601 - 2- 49
Medical electrical equipment
Part 2: Particular requirements for the safety of multifunction patient monitoring equipment
Report No.. ..................................... : TR-12345a
(Note: The NCB rules for numbering system shall be used – Original Report Ref.
No may include a suffix or it can be a new number, or it may be unchanged
number as long as the Amendment Report can be link to the Original report
without ambiguity).

Date of issue.................................... : 2005 February 8, Amendment No. 2: 2007 March 16

Total number of pages ...................... Enter number of pages

CB Testing Laboratory .................. : Name of Testing Laboratory (for LTR procedure see Clause 4.4)
Address ........................................... : Testing Laboratory address
Applicant’s name ........................... : Company name
Address ........................................... : Company address
Test specification:
Standard .......................................... : IEC 60601-2-49, First Edition (2001)
Test procedure ................................ : CB Scheme
Non-standard test method…………..: N/A
Test Report Form No. .................... : IEC60601_2_49A
Test Report Form(s) Originator ........ : Underwriters Laboratories Inc.
Master TRF...................................... : Dated April 2003
Copyright © 2006 Worldwide System for Conformity Testing and Certification of Electrical
Equipment and Components (IECEE), Geneva, Switzerland. All rights reserved.
This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as
copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from
the reader's interpretation of the reproduced material due to its placement and context.

If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo and the reference to the CB
Scheme procedure shall be removed.
This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and
appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02.
Test item description ......................: Monitoring System
Trade Mark ...................................... : None
Manufacturer ................................... : Same as Applicant
Model/Type reference...................... : Models ABC-123, AP139 and AP154
Ratings ............................................ : 12 V dc, 500 mA

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Annex F

Testing procedure and testing location:

CB Testing Laboratory: Name of the Main Testing Laboratory

Testing location/ address ......................... : Address of the Main Testing Laboratory

Associated CB Laboratory: Name of Associated Testing Laboratory

Testing location/ address ......................... : Address of Associated Testing Laboratory

Tested by (name + signature) ....... : Name signature

Approved by (name + signature) Name signature
Testing procedure: TMP
Testing location/ address ......................... :

Tested by (name + signature) ...... :

Approved by (name + signature .... :
Testing procedure: WMT
Testing location/ address ......................... :

Tested by (name + signature) ...... :

Witnessed by (name + signature) . :
Approved by (name + signature) .. :
Testing procedure: SMT
Testing location/ address ......................... :

Tested by (name + signature) ...... :

Approved by (name + signature) .. :
Supervised by (name + signature) :
Testing procedure: RMT
Testing location/ address ......................... :

Tested by (name + signature) ...... :

Approved by (name + signature) .. :
Supervised by (name + signature) :

TRF IEC60601_2_49A

Note 1: In the above example, testing was conducted by an ACTL (Satellite CB Testing Laboratory
under the supervision of its Main CBTL. – See OD-2015).

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Annex F

List of Attachments (including a total number of pages in each attachment):

This Amendment to the original Report Ref. No. TR-12345a contains 8 Report Pages and one new
photograph.

Summary of testing:

Tests performed (name of test and test clause): Testing location:

(Provide information about testing conducted for Testing location: ACTL name
this Amendment, as appropriate.)
Input test
Heating test

Summary of compliance with National Differences

List of countries addressed:
Instruction: Provide information about verified/tested to National Differences.
In case of technical modifications to the product, state if modified products still complies with previously
evaluated National Differences.

The product fulfils the requirements of _________ (insert standard number and edition and delete the
text in parenthesis or delete the whole sentence if not applicable).
Copy of marking plate:
“The artwork below may be only a draft. The use of certification marks on a product must be authorized by
the respective NCBs that own these marks”

Instruction: Provide copy of a new marking plate (or artwork) for new models added, or when marking
plate changed due to modified ratings, trademark, and other changes, as applicable.

TRF IEC60601_2_49A

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Annex F

Test item particulars................................................. :

Classification of installation and use........................... : See IEC 60601-1 Test Report
Device type ................................................................ : MULTIFUNCTION PATIENT MONITORING EQUIPMENT
- having more than one APPLIED PART
Contact Surface Temperature (TR) .......................... : 36 ºC
Accessories and detachable parts included .............: N/A
Other options included ..........................................: N/A
Possible test case verdicts:
- test case does not apply to the test object ................ : N/A
- test object does meet the requirement ...................... : Pass (P)
- test object does not meet the requirement ................ : Fail (F)
Testing:
Date of receipt of test items ......................................... : 2007 March 2
Date(s) of performance of tests ................................... : 2007 March 7-9
Abbreviations used in the report:
- normal condition: N.C. - single fault condition: S.F.C.
- operational insulation: OP - basic insulation: BI
- double insulation: DI - supplementary insulation: SI
- basic insulation between - reinforced insulation: RI
parts of opposite polarity: BOP
General remarks:
The test results presented in this report relate only to the object tested.
This report shall not be reproduced, except in full, without the written approval of the Issuing testing
laboratory.
"(see Enclosure #)" refers to additional information appended to the report.
"(see appended table)" refers to a table appended to the report.
List of test equipment must be kept on file and available for review.
This Test Report contains the general safety requirements as related to the usability of Medical
Electrical Equipment. It can only be used together with IEC 60601-1 Test Report.

Throughout this report a comma / point is used as the decimal separator.

Manufacturer’s Declaration per Sub-clause 6.2.5 of IECEE 02:

The application for obtaining a CB Test Certificate Yes
includes more than one factory location and a
declaration from the Manufacturer stating that the
sample(s) submitted for evaluation is (are)
representative of the products from each factory has
been provided .............................................................. :

When differences exist; they shall be identified in the General Product Information section.

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Annex F

Name and address of factory (ies) ......................... : Provide factory information

General product information:

The multifunction patient monitoring equipment consists of a patient control console with two applied parts,
data store module and a serial port adapter. The system serves as a means of transferring data from the
monitoring system console to a PC. The Data Store system is Class III and powered by a direct plug-in power
supply with a 12 V dc, 500 mA, SELV, Limited Power, output. Instructions are provided for choosing a
suitable supply.

Amendment 1 Report:
The original Test Report Ref. No. TR-12345a, dated 2005 February 8 was modified on June 22, 2005 to
include the following changes and/or additions, which were considered technical modifications:
New models added:
The two new Models AP139 and AP154 are multifunction patient monitoring equipment identical to the
previous Model ABC-123, except for minor variations in the SELV circuitry and markings. After review of the
construction, no additional tests were considered necessary.

Amendment 2 Report:
The original Test Report Ref. TR-12345a, dated 2005 February 8 was additionally modified on March 16,
2007 to include the following changes and/or additions, which were considered technical modifications:
New critical component xxx was added
Two tests were considered necessary. See the “Summary of testing”.
A photo of modified printed wiring board with new component layout was added.

TRF IEC60601_2_49A

Note 2: In this example, additional pages (such as pages with test tables for conducted tests,
component table) or pages that are affected by the product modifications should follow pages shown
above. A photo-documentation needs be attached to this Amendment Report.

Note 3: The example shows Amendment 2 Report issued due to the technical modification to the
product (critical components were added) with limited testing. However, the original Test Report was
already modified once by Amendment 1 Report, which has been issued because new models were
added. In this case, after engineering review of the differences and similarities between originally
tested models and new models, no tests were considered necessary. In the provided example, the
history of all changes and the reasons why the Amendment Reports have been issued are clearly
documented.

Note 4: Only one more technical modification to the product is still allowed in the example given above
before a new CB Test Reports shall be issued. (Refer also to IECEE 02, Clause 4.2.4.).

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Annex G
TRF Flowchart for Originators, Administrator and Users

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Annex H

Distribution of TRFs

The IECEE Secretariat maintains a list of completed TRFs and TRFs in preparation, which
includes the expected completion date.

The assigned TRF Originator shall always inform the IECEE Secretariat on completion of the
relevant TRF(s). The completed Master TRF(s) shall be sent by e-mail to the IECEE Secretariat
in Geneva for distribution.

Contact Persons at the IECEE Secretariat are:

Mr. Pierre de Ruvo

IECEE Secretary
3, rue de Varembé
PO Box 131
CH-1211 GENEVA 20
SWITZERLAND
E-mail: [email protected]
Tel: +41 22 919 0207
Fax: +41 22 919 0300

Ms. Sonia Alves-Polidori

3, rue de Varembé
PO Box 131
CH-1211 GENEVA 20
SWITZERLAND
E-mail: [email protected]
Tel: +41 22 919 0223

Suggestions about changes/improvements to the TRF template(s) and Operational Document OD-
2020 shall be communicated to the IECEE Contact Persons identified above.
The IECEE Secretariat shall provide the collected input to the WG 9 (TRFs) Convener for review
and discussion at the next WG meeting, and later report to the CMC, when found appropriate.

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Annex I

Request form for corrections to the published TRF

TRF Ref. No.: Standard: Request date:

TRF Originator: Requesting NCB: Decision date:

Master TRF date: Contact person: Decision taken by:

Sub-clause: Issue to be addressed: Decision:

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Annex J

The originator shall always use the latest TRF template available at the IECEE Website at
http://www.iecee.org/cbscheme/html/cbtrep.htm. This applies to the TRF itself, to the National Differences
templates and standardized attachments.

The list of available Test Report Forms as well as the list of Test Report Forms in preparation (including the
expected completion date) can also be found on the IECEE Website.

Link to the TRF and National Differences templates, and List of available TRFs

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