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Preview - ISO 8655 1 2022

This document provides terminology, general requirements, and user recommendations for piston-operated volumetric apparatus such as pipettes, burettes, dilutors, dispensers, and syringes. It specifies the frequency of required calibrations and tests, how to report measurement errors, requirements for exchangeable parts and metrological confirmation. The document also provides recommendations on product information, factors affecting choice of apparatus, and marking requirements.

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0% found this document useful (0 votes)
68 views10 pages

Preview - ISO 8655 1 2022

This document provides terminology, general requirements, and user recommendations for piston-operated volumetric apparatus such as pipettes, burettes, dilutors, dispensers, and syringes. It specifies the frequency of required calibrations and tests, how to report measurement errors, requirements for exchangeable parts and metrological confirmation. The document also provides recommendations on product information, factors affecting choice of apparatus, and marking requirements.

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s7631040
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INTERNATIONAL ISO

STANDARD 8655-1

Second edition
2022-04

Piston-operated volumetric
apparatus —
Part 1:
Terminology, general requirements
and user recommendations
iTeh STANDARD
Appareils volumétriquesPREVIEW
à piston —
Partie 1: Définitions, exigences générales et recommandations pour
(standards.iteh.ai)
l'utilisateur

ISO 8655-1:2022
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8655-1-2022

Reference number
ISO 8655-1:2022(E)

© ISO 2022
ISO 8655-1:2022(E)

iTeh STANDARD PREVIEW


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ISO 8655-1:2022
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8655-1-2022

COPYRIGHT PROTECTED DOCUMENT


© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland

ii  © ISO 2022 – All rights reserved



ISO 8655-1:2022(E)

Contents Page

Foreword......................................................................................................................................................................................................................................... iv
Introduction..................................................................................................................................................................................................................................v
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references...................................................................................................................................................................................... 1
3 Terms and definitions..................................................................................................................................................................................... 1
4 Abbreviated terms.............................................................................................................................................................................................. 6
5 Types of piston-operated volumetric apparatus................................................................................................................ 6
5.1 General............................................................................................................................................................................................................ 6
5.2 Pipettes.......................................................................................................................................................................................................... 6
5.3 Burettes......................................................................................................................................................................................................... 7
5.4 Dilutors........................................................................................................................................................................................................... 7
5.5 Dispensers................................................................................................................................................................................................... 7
5.6 Syringes......................................................................................................................................................................................................... 7
6 General requirements..................................................................................................................................................................................... 7
6.1 Frequency of calibrations and tests..................................................................................................................................... 7
6.2 Reporting measurement errors............................................................................................................................................... 7
6.3 Exchangeable Parts............................................................................................................................................................................. 7
6.4 Metrological confirmation ........................................................................................................................................................... 8
6.5 iTeh STANDARD PREVIEW
Routine testing........................................................................................................................................................................................ 8
6.6 Maintenance and repair.................................................................................................................................................................. 8
6.7
6.8
(standards.iteh.ai)
Suitability to give statements on performance.......................................................................................................... 8
Determination of pass/fail status........................................................................................................................................... 9
7 Product information......................................................................................................................................................................................... 9
7.1
ISO 8655-1:2022
User information.................................................................................................................................................................................... 9
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7.2 Decontamination and sterilisation........................................................................................................................................ 9
7.3 8655-1-2022
Chemical resistance............................................................................................................................................................................ 9
8 Factors affecting choice of piston-operated volumetric apparatus............................................................... 9
8.1 Interaction with liquids................................................................................................................................................................... 9
8.2 Use of air displacement pipettes........................................................................................................................................... 10
9 Marking........................................................................................................................................................................................................................ 10
Bibliography.............................................................................................................................................................................................................................. 11

© ISO 2022 – All rights reserved  iii


ISO 8655-1:2022(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
iTeh STANDARD PREVIEW
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
(standards.iteh.ai)
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 48, Laboratory equipment, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 332, Laboratory
ISO 8655-1:2022
equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
https://standards.iteh.ai/catalog/standards/sist/97fcd5e3-9c42-4c81-9179-08e285b90d3d/iso-
Agreement).
8655-1-2022
This second edition cancels and replaces the first edition (ISO 8655‐1:2002), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 8655‐1:2002/Cor.1:2008.
The main changes are as follows:
— ISO 8655-7, ISO 8655-8, and ISO 8655-9 have been added as normative references;
— abbreviated terms have been introduced as Clause 4;
— terms and definitions have been revised and some new ones included;
— general requirements for frequency of calibration, reporting measurement errors, exchangeable
parts, metrological confirmation, routine testing, and maintenance and repair, suitability of
statements on performance and determination of pass/fail status have been added in Clause 6.
A list of all parts in the ISO 8655 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv  © ISO 2022 – All rights reserved



ISO 8655-1:2022(E)

Introduction
The ISO 8655 series addresses the needs of:
— manufacturers, as a basis for quality control including, where appropriate, the issuance of
manufacturer’s declarations;
— calibration laboratories, test houses, users of the equipment and other bodies as a basis for
independent calibration, testing, verification and routine tests.
The tests specified in the ISO 8655 series are intended to be carried out by trained personnel.

iTeh STANDARD PREVIEW


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ISO 8655-1:2022
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© ISO 2022 – All rights reserved  v


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8655-1-2022
INTERNATIONAL STANDARD ISO 8655-1:2022(E)

Piston-operated volumetric apparatus —


Part 1:
Terminology, general requirements and user
recommendations

1 Scope
This document specifies general requirements for piston-operated volumetric apparatus (POVA). It
is applicable to pipettes, burettes, dilutors, dispensers and manually operated precision laboratory
syringes. It furthermore defines terms for the use of piston-operated volumetric apparatus and gives
user recommendations.
This document does not apply to medical products intended for use on humans, e.g. for medical syringes.

2 Normative references

iTeh STANDARD PREVIEW


The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
(standards.iteh.ai)
ISO 8655-2, Piston-operated volumetric apparatus — Part 2: Pipettes
ISO 8655-3, Piston-operated volumetric ISO
apparatus — Part 3: Burettes
8655-1:2022
ISOhttps://standards.iteh.ai/catalog/standards/sist/97fcd5e3-9c42-4c81-9179-08e285b90d3d/iso-
8655-4, Piston-operated volumetric apparatus — Part 4: Dilutors
8655-1-2022
ISO 8655-5, Piston-operated volumetric apparatus — Part 5: Dispensers
ISO 8655-6, Piston-operated volumetric apparatus — Part 6: Gravimetric reference measurement
procedure for the determination of volume
ISO 8655-7, Piston-operated volumetric apparatus — Part 7: Alternative measurement procedures for the
determination of volume
ISO 8655-8, Piston-operated volumetric apparatus — Part 8: Photometric reference measurement
procedure for the determination of volume
ISO 8655-9, Piston-operated volumetric apparatus — Part 9: Manually operated precision laboratory
syringes

3 Terms and definitions


For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://​w ww​.iso​.org/​obp
— IEC Electropedia: available at https://​w ww​.electropedia​.org/​

© ISO 2022 – All rights reserved  1


ISO 8655-1:2022(E)

3.1
adjustment
〈POVA〉 set of operations carried out so that the delivered volume more closely corresponds to the
nominal or selected volume
Note 1 to entry: Information about the correct adjustment method can be found in the manufacturer’s instruction
manual. Some devices have more than one adjustment method. Some have none at all.

3.2
balance
〈POVA〉 device used to determine the mass of a delivered volume
3.3
bandpass filter
optical filter used to selectively transmit a band of wavelengths from the total spectrum while rejecting
shorter and longer wavelengths than those within the transmission band
3.4
calibration
〈POVA〉 set of operations that establish the relationship between the delivered volume and the
corresponding selected volume of the apparatus with associated measurement uncertainties
Note 1 to entry: Calibration requires no operation which permanently modifies the apparatus and does not
require adjustment of the device.

3.5
coefficient of variation iTeh STANDARD PREVIEW
random error expressed as a percentage of the mean delivered volume
3.6
(standards.iteh.ai)
correction
ISO 8655-1:2022
mathematical compensation of a systematic effect
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Note 1 to entry: In the context of this document, a systematic error can be mathematically compensated by
subtracting it from the selected volume. 8655-1-2022

Note 2 to entry: The correction is applied when the user is setting the indication to deliver the corrected intended
volume.

3.7
chromophore
compound which absorbs photons of a specific energy
3.8
dead air volume
headspace
captive air volume
air cushion
〈air displacement pipettes〉 air volume between the piston and the surface of the liquid in the tip
3.9
dead volume
〈POVA〉 amount of liquid that does not belong to the delivered volume and which is contained during
operation in aspiration or expelling tubes, valves and within the cylinder
3.10
evaporation trap
accessory used in a balance that minimizes evaporation of test liquid from the weighing vessel
3.11
immersion depth
〈piston pipette〉 depth of the tip orifice of the piston pipette below the liquid surface

2  © ISO 2022 – All rights reserved



ISO 8655-1:2022(E)

3.12
liquid handling process tolerance
user-specified tolerance defining the maximum acceptable uncertainty in use of the delivered volume
Note 1 to entry: A POVA is fit for its intended purpose if its uncertainty in use is smaller than or equal to the liquid
handling process tolerance.

Note 2 to entry: The liquid handling process tolerance is typically expressed as a percentage of the nominal or
selected volume.

3.13
maximum permissible systematic error
permitted extreme value for the deviation of the mean delivered volume from the nominal volume or
selected volume
Note 1 to entry: The maximum permissible systematic errors of piston-operated volumetric apparatus are
specified in ISO 8655-2 to ISO 8655-5, and ISO 8655-9.

3.14
maximum permissible random error
permitted extreme value for the variation of the delivered volumes around the mean of the delivered
volumes
Note 1 to entry: The maximum permissible random errors of piston-operated volumetric apparatus are specified
in ISO 8655-2 to ISO 8655-5 and ISO 8655-9.

3.15 iTeh STANDARD PREVIEW


mean delivered volume
(standards.iteh.ai)
arithmetic mean of multiple replicate delivered volumes obtained by the measurement method
3.16
measurement ISO 8655-1:2022
process of experimentally obtaining one or more quantity values that can be reasonably attributed to a
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quantity
8655-1-2022
3.17
measurement accuracy
accuracy
〈POVA〉 closeness of agreement between delivered volume and the nominal volume or selected volume
Note 1 to entry: The concept ‘measurement accuracy’ is not given as a numerical value. A measurement is said to
be more accurate when it offers a smaller measurement error.

Note 2 to entry: The term ‘measurement accuracy’ is not the same as ‘measurement trueness’ or ‘measurement
precision'.

3.18
measurement repeatability
measurement precision under a set of repeatability conditions of measurement
3.19
measurement uncertainty
〈volume as delivered by a POVA〉 non-negative parameter, associated with the delivered volume, that
characterizes the dispersion of the volumes that could reasonably be attributed to the delivered volume
based on the information used
Note 1 to entry: When POVA are calibrated according to one of the procedures in ISO 8655-6, ISO 8655-7, or
ISO 8655-8, the uncertainty of the mean delivered volume is usually estimated and reported.

Note 2 to entry: When POVA are used in the laboratory the uncertainty in use of a single delivered volume can be
estimated and is discussed further in ISO 8655-10. This uncertainty is likely to be larger than the uncertainty of
the mean delivered volume.

© ISO 2022 – All rights reserved  3



ISO 8655-1:2022(E)

Note 3 to entry: ISO/TR 20461 and ISO/TR 16153 provide examples of the estimation of the uncertainty of the
mean delivered volume and the uncertainty in use of a single delivered volume.

3.20
measuring system
set of one or more measuring instruments, and often other devices, including any reagents and supplies,
assembled and adapted to give information used to generate measured volumes within specified
intervals for quantities of specified kinds
[SOURCE: ISO/IEC Guide 99:2007, 3.2, modified — Note to entry was deleted, and definition has been
modified for the purpose of the POVA standard]
3.21
measuring system uncertainty
value related to the method used for the determination of volume, which does not include the
uncertainty of the POVA under test or the operator effect
3.22
metrological confirmation
set of operations required to ensure that the POVA conforms to the requirements for its intended use
Note 1 to entry: Metrological confirmation generally includes calibration and verification, and any necessary
adjustment or repair, and subsequent recalibration, comparison with the metrological requirements for the
intended use of the POVA, as well as any required sealing and labelling.

iTeh STANDARD PREVIEW


Note 2 to entry: The requirements for intended use include such considerations as range, resolution, and
maximum permissible errors.

(standards.iteh.ai)
Note 3 to entry: Metrological requirements are usually distinct from, and are not specified in, product
requirements.

[SOURCE: ISO 9000:2015, 3.5.6, modified — definition and Note 1 to entry have been modified for the
ISO 8655-1:2022
purpose of the POVA standard, Note 2 to entry has been deleted and following notes to entries were
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renumbered.]
8655-1-2022
3.23
metrological traceability
property of a measurement result whereby the result can be related to a reference through a
documented unbroken chain of calibrations, each contributing to the measurement uncertainty
[SOURCE: ISO/IEC Guide 99:2007, 2.41, modified — Notes to entry have been deleted.]
3.24
nominal volume
〈POVA〉 upper limit of the usable volume range as specified by the manufacturer
Note 1 to entry: For specific piston-operated volumetric apparatus, this definition is further qualified in the
applicable parts of ISO 8655.

3.25
photometric repeatability
standard deviation of at least 10 absorbance measurements at a specific wavelength using a glass filter
calibration standard
3.26
precision
〈POVA〉 closeness of agreement between replicate delivered volumes obtained under repeatability
conditions
Note 1 to entry: The error characterizing precision is the random error (3.27).

4  © ISO 2022 – All rights reserved




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