इंटरनेट मानक

Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to
information for citizens to secure access to information under the control of public authorities,
in order to promote transparency and accountability in the working of every public authority,
and whereas the attached publication of the Bureau of Indian Standards is of particular interest
to the public, particularly disadvantaged communities and those engaged in the pursuit of
education and knowledge, the attached public safety standard is made available to promote the
timely dissemination of this information in an accurate manner to the public.

“जान1 का अ+धकार, जी1 का अ+धकार” “प0रा1 को छोड न' 5 तरफ”

Mazdoor Kisan Shakti Sangathan Jawaharlal Nehru
“The Right to Information, The Right to Live” “Step Out From the Old to the New”

IS/ISO 9170-1 (2008): Terminal units for medical gas

pipeline systems, Part 1: Terminal units for use with
compressed medical gases and vacuum [MHD 11: Anaesthetic,
Resuscitation and Allied Equipment]

“!ान $ एक न' भारत का +नम-ण”

Satyanarayan Gangaram Pitroda
“Invent a New India Using Knowledge”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता ह”

है”
ह
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”
 IS/ISO 9170-1 : 2008

Hkkjrh; ekud
fpfdRlk xSl ikbiykbu ra=k osQ fy, VfeZuy bdkb;k¡
Hkkx 1 laihfMr fpfdRlk xSl vkSj fuokZr esa ç;ksx osQ fy, VfeZuy bdkb;k¡

Indian Standard
TERMINAL UNITS FOR
MEDICAL GAS PIPELINE SYSTEMS
PART 1 TERMINAL UNITS FOR USE WITH COMPRESSED
MEDICAL GASES AND VACUUM

ICS 11.040.10

© BIS 2011
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002

August 2011 Price Group 9

Anaesthetic, Resuscitation and Allied Equipment Sectional Committee, MHD 11

NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical with ISO 9170-1 : 2008 ‘Terminal units for medical
gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum’
issued by the International Organization for Standardization (ISO) was adopted by the Bureau of
Indian Standards on the recommendation of the Anaesthetic, Resuscitation and Allied Equipment
Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

Terminal units are the points on the medical gas pipeline system where the operator makes connections
and disconnections for the supply of specified medical gases to anaesthetic machines, lung ventilators
or other items of medical equipment. A wrong connection can create a hazard to the patient or
operator. It is important that terminal units and their components be designed, manufactured, installed
and maintained in such a way as to meet the basic requirements specified in this standard.

This standard pays particular attention to suitability of materials, gas specificity, cleanliness, testing,
identification and information supplied.

This standard specifies the provision of information for the installation and subsequent testing of
terminal units prior to use. Testing of terminal units prior to use is critical to patient safety, and it is
essential that terminal units are not used until full testing has been completed.

This standard is also intended especially to ensure the gas-specific assembly of terminal units and
to prevent their interchange between different gases and services. It specifies requirements for terminal
units for supply and disposal of nitrogen or air for driving surgical tools and also specifies requirements
for probes intended to be connected to the gas-specific connection point which is part of the terminal
unit.

Annex A contains rationale statements for some of the requirements of this standard. The clauses
and subclauses marked with an asterisk(*) after their number have corresponding rationale contained
in Annex A, included to provide additional insight into the reasoning that led to the requirements and
recommendations that have been incorporated in this standard. It is considered that knowledge of
the reasons for the requirements will not only facilitate the proper application of this standard, but will
expedite any subsequent revisions.

This standard is published in two parts. The other part of this standard is:

Part 2 Terminal units for anaesthetic gas scavenging systems

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without
deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention
is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be
read as ‘Indian Standard’.
b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice
is to use a point (.) as the decimal marker.

(Continued on third cover)

 IS/ISO 9170-1 : 2008

Indian Standard
TERMINAL UNITS FOR
MEDICAL GAS PIPELINE SYSTEMS
PART 1 TERMINAL UNITS FOR USE WITH COMPRESSED
MEDICAL GASES AND VACUUM

1 Scope
1.1 This part of ISO 9170 applies to:

a) terminal units intended for use in medical gas pipeline systems in accordance with ISO 7396-1, for use
with the following medical gases:

⎯ oxygen;

⎯ nitrous oxide;

⎯ medical air;

⎯ carbon dioxide;

⎯ oxygen/nitrous oxide mixture [50 %/50 % (by volume)];

b) terminal units intended for use in medical gas pipeline systems in accordance with ISO 7396-1, for use
with the following gases and services:

⎯ oxygen-enriched air;

⎯ air for driving surgical tools;

⎯ nitrogen for driving surgical tools;

⎯ vacuum.

NOTE 1 Different names or symbols are used for air for driving surgical tools, such as instrument air, surgical air, air
motor, air-700 and air-800.

NOTE 2 The requirements of this part of ISO 9170 can be used as guidelines for terminal units for other gases. These
other gases will be considered for inclusion in this part of ISO 9170 when they come into general use.

It is intended especially to ensure the gas-specific assembly of terminal units and to prevent their interchange
between different gases and services.

1.2 This part of ISO 9170 specifies requirements for terminal units for supply and disposal of nitrogen or air
for driving surgical tools.

1.3 This part of ISO 9170 specifies requirements for probes intended to be connected to the gas-specific
connection point which is part of the terminal unit.

1
IS/ISO 9170-1 : 2008

1.4 This part of ISO 9170 does not specify the dimensions of probes or of the gas-specific connection
points of the terminal units.

NOTE Certain regional or national standards specifying dimensions of probes and gas-specific connection points are
given in the Bibliography.

1.5 This part of ISO 9170 does not specify the dimensions of NIST connectors, which are defined in
ISO 5359.

1.6 This part of ISO 9170 does not specify the dimensions of DISS connectors, which are defined in
CGA V-51) [12].

1.7 This part of ISO 9170 does not specify the requirements for terminal units for anaesthetic gas
scavenging systems (AGSS), which are covered in ISO 9170-2.

2 * Normative references
The following referenced documents are indispensable for the application 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.

ISO 32:1977, Gas cylinders for medical use — Marking for identification of content

ISO 5359:—2), Low-pressure hose assemblies for use with medical gases

ISO 6506-1:2005, Metallic materials — Brinell hardness test — Part 1: Test method

ISO 7396-1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum

ISO 11114-3:1997, Transportable gas cylinders — Compatibility of cylinder and valve materials with gas
contents — Part 3: Autogenous ignition test in oxygen atmosphere

ISO 14971:2007, Medical devices — Application of risk management to medical devices

ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

NOTE A diagram of a typical terminal unit and probe, with an example of terminology, is shown in Figure 1.

3.1
diameter-index safety system connector
DISS connector
any of a range of male and female components intended to maintain gas-specificity by allocation of a set of
different diameters to the mating connectors for each particular gas

3.2
gas-specific
having characteristics which prevent connections between different gas services

1) CGA = Compressed Gas Association.

2) To be published. (Revision of ISO 5359:2000)

2
 IS/ISO 9170-1 : 2008

3.3
gas-specific connection point
that part of the socket which is the receptor for a gas-specific probe

3.4
gas-specific connector
connector with dimensional characteristics that prevent connections between different gas services

NOTE Examples of gas-specific connectors are quick connectors, screw-threaded connectors, diameter-index safety
system (DISS) connectors or non-interchangeable screw-threaded (NIST) connectors.

3.5
low-pressure hose assembly
assembly that consists of a flexible hose with permanently attached gas-specific inlet and outlet connectors,
and which is designed to conduct a medical gas at pressures less than 1 400 kPa

3.6
medical gas
any gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic
purposes, or for surgical tool application(s)

3.7
medical gas pipeline system
complete system which comprises a supply system, a monitoring and alarm system and a pipeline distribution
system with terminal units at the points where medical gases or vacuum may be required

3.8
medical gas supply system
either

a) a medical gas pipeline system or

b) an installation having no permanent pipeline system but employing a medical gas supply source complete
with pressure regulator(s)

3.9
nominal distribution pressure
pressure which the medical gas pipeline system is intended to deliver at the terminal units

NOTE Unless otherwise specified, pressures in this part of ISO 9170 are expressed as gauge pressures
(i.e. atmospheric pressure is defined as 0).

3.10
non-interchangeable screw-threaded connector
NIST connector
range of male and female components intended to maintain gas specificity by the allocation of a set of
different diameters and a left- or right-hand screw thread to the mating components for each particular gas

3.11
probe
gas-specific male component designed for acceptance by and retention in the socket

3.12
quick connector
pair of non-threaded gas-specific components which can be easily and rapidly joined together by a single
action of one or both hands without the use of tools

3
IS/ISO 9170-1 : 2008

3.13
single-fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a single
external abnormal condition is present

3.14
socket
female part of a terminal unit which is either integral or attached to the terminal unit base block by a gas-
specific interface and which contains the gas-specific connection point

3.15
terminal unit
outlet assembly (inlet for vacuum) in a medical gas supply system at which the operator makes connections
and disconnections

3.16
terminal unit base block
that part of a terminal unit which is attached to the pipeline distribution system

3.17
terminal unit check valve
valve which remains closed until opened by insertion of an appropriate probe and which then permits flow in
either direction

3.18
terminal unit maintenance valve
valve that permits maintenance of the terminal unit without shutting down the pipeline system to other terminal
units

3.19
terminal unit for supply and disposal of nitrogen or air for driving surgical tools
combination of an outlet assembly (for supply) and an inlet assembly (for disposal) which are connected to a
medical gas pipeline system and to a gas disposal system respectively and at which the operator makes
connections and disconnections by means of a combined probe

4
 IS/ISO 9170-1 : 2008

Key
1 NIST or DISS body
2 hose insert
3 point for brazed connection
4 base block
5 maintenance valve
6 check valve
7 gas-specific interface
8 socket
9 gas-specific connection point
10 probe

Figure 1 — Typical components of a terminal unit and probe

5
IS/ISO 9170-1 : 2008

4 General requirements

4.1 Safety

Terminal units shall, when transported, stored, installed, operated in normal use and maintained according to
the instructions of the manufacturer, present no risks that are not reduced to an acceptable level using risk
management procedures in accordance with ISO 14971 and which are connected with their intended
application, in normal condition and in single fault condition.

NOTE Maintenance of equipment is considered a normal condition.

4.2 * Alternative construction

Terminal units and components, or parts thereof, which use materials or have forms of construction different
from those detailed in this clause, shall be presumed to be in compliance with the safety objectives of this part
of ISO 9170 if it can be demonstrated that an equivalent degree of safety is obtained (i.e. compliance with
requirements presumes that risks have been mitigated to acceptable levels) unless objective evidence to the
contrary becomes available.

Evidence of an equivalent degree of safety shall be provided by the manufacturer upon request.

NOTE 1 Objective evidence can be obtained by postmarket surveillance.

NOTE 2 Regional or national regulations might require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.

4.3 Materials

4.3.1 Materials in contact with the gases listed in 1.1, during normal use shall be resistant to corrosion and
compatible with oxygen, the other gases and their mixtures in the temperature range specified in 4.3.2.

NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials.

NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials that burn in air burn
violently in pure oxygen. Many materials that do not burn in air will do so in pure oxygen, particularly under pressure.
Similarly, materials that can be ignited in air require lower ignition energies in oxygen. Many such materials can be ignited
by friction at a valve seat or by adiabatic compression produced when oxygen at high pressure is rapidly introduced into a
system initially at low pressure.

NOTE 3 ISO 15001 contains information on selection of metallic and non-metallic materials and other aspects of
compatibility of equipment with oxygen.

NOTE 4 Regional or national regulations may require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.

4.3.2 The materials shall permit the terminal units and their components to meet the requirements of 4.4 in
the temperature range of −20 °C to +60 °C.

4.3.3 Terminal units shall meet the requirements of 4.4 after being exposed, while packed for transport and
storage, to environmental conditions as specified by the manufacturer.

4.3.4 Springs, highly strained components and parts liable to wear which come in contact with the gas shall
not be plated.

NOTE Plating could come off.

6
 IS/ISO 9170-1 : 2008

4.3.5 For terminal units for all gases, the autoignition temperature of the non-metallic components in contact
with the gas, including the sealing materials and lubricants (if used), shall not be lower than 160 °C.

The determination of the autoignition temperature shall be carried out in accordance with ISO 11114-3.

NOTE The maximum permitted operating temperature of tested material is 100 °C lower than the autoignition
temperature at the corresponding oxygen pressure. This safety margin is necessary because it covers both an unforeseen
increase in the operating temperature and the fact that the autoignition temperature is not a constant. Values of the
autoignition temperature always depend on the test method used, which may not exactly simulate all possible operating
conditions.

4.3.6 Evidence of conformity with the requirements of 4.3.1 to 4.3.5 shall be provided by the manufacturer
upon request.

NOTE Regional or national regulations may require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.

4.4 Design requirements

4.4.1 Medical gas supply pressure

4.4.1.1 Terminal units for oxygen, oxygen-enriched air, nitrous oxide, medical air, carbon dioxide and
oxygen/nitrous oxide mixture (50 %/50 % by volume) shall operate and meet the requirements of this part of
ISO 9170 for a medical gas supply having a pressure range from 320 kPa to 600 kPa.

4.4.1.2 Terminal units for oxygen, oxygen-enriched air, nitrous oxide, medical air, carbon dioxide and
oxygen/nitrous oxide mixture (50 %/50 % by volume) shall not create a hazard at an inlet pressure of
1 200 kPa.

4.4.1.3 Terminal units for oxygen, oxygen-enriched air, nitrous oxide, medical air, carbon dioxide and
oxygen/nitrous oxide mixture (50 %/50 % by volume) shall meet the requirements of 4.4.1.1 following
exposure to an inlet pressure of 1 200 kPa for 5 min.

4.4.1.4 Terminal units for nitrogen or air for driving surgical tools shall operate and meet the requirements
of this part of ISO 9170 for a medical gas supply having a pressure range from 560 kPa to 1 200 kPa.

4.4.1.5 Terminal units for nitrogen or air for driving surgical tools shall not create a hazard at an inlet
pressure of 2 400 kPa.

4.4.1.6 Terminal units for nitrogen or air for driving surgical tools shall meet the requirements of 4.4.1.4
following exposure to an inlet pressure of 2 400 kPa for 5 min.

4.4.1.7 Terminal units for vacuum shall operate and meet the requirements of this part of ISO 9170 for a
vacuum supply having a pressure range from 10 kPa to 60 kPa absolute.

4.4.1.8 * Terminal units for vacuum shall not create a hazard at a test pressure of 500 kPa applied to the
base block.

4.4.1.9 * Terminal units for vacuum shall meet the requirements of 4.4.1.7 following exposure to a test
pressure of 500 kPa applied for 5 min to the base block.

4.4.1.10 Evidence of conformity with the requirements of 4.4.1.1 to 4.4.1.9 shall be provided by the
manufacturer upon request.

NOTE Regional or national regulations may require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.

7
IS/ISO 9170-1 : 2008

4.4.2 Terminal units for different pressures

Terminal units for the same gas at different nominal distribution pressures (e.g. medical air and air for driving
surgical tools) shall have gas-specific connection points for each pressure.

4.4.3 Retention of gas specificity

If any gas-specific component is removed from the terminal unit, the gas specificity of the terminal unit shall be
retained, or the terminal unit shall be rendered inoperable. If the terminal unit can be dismantled, it shall not be
possible to re-assemble the components in such a way that the fully-assembled terminal unit is no longer gas-
specific.

4.4.4 Gas-specific connection point

Each terminal unit shall include a gas-specific connection point that shall accept the appropriate gas-specific
probe only. This connection point shall be included in a socket.

4.4.5 Terminal unit check valve

Each terminal unit shall include a check valve that shall open the gas supply when the probe is connected and
shall shut off automatically when the probe is disconnected. The check valve shall be a component or
assembly separate from the maintenance valve specified in 4.4.6.

4.4.6 Terminal unit maintenance valve

Except for vacuum services, each terminal unit shall be equipped with a maintenance valve, that may be
manual or automatic. The maintenance valve shall be a separate component or assembly from the check
valve specified in 4.4.5.

4.4.7 Connection of terminal units to the pipeline (see also 7.2)

4.4.7.1 Except for connection to a disposal system for nitrogen or air for driving surgical tools, the base
block of a terminal unit shall be designed and manufactured for either permanent (e.g. by brazing or welding)
or gas-specific (e.g. by means of an NIST or DISS body) connection to a pipeline distribution system. The
connection shall comply with ISO 7396-1.

4.4.7.2 Connection to a low-pressure hose shall be either by direct ferruling on to a hose insert or by
means of an NIST or DISS body and shall comply with ISO 5359. (See Figure 1.)

4.4.8 Socket

The attachment of a socket to its base block for a particular service shall be gas-specific.

4.4.9 Compliance

Compliance with 4.4.2 to 4.4.8 shall be tested by visual inspection, functional testing and/or measurement.

4.4.10 Endurance (connection/release)

4.4.10.1 Socket

The socket shall retain gas specificity and meet the requirements given in 4.4.11 to 4.4.17 after testing in
accordance with 5.2.1.

4.4.10.2 Probe

The probe shall retain gas specificity and meet the requirements given in 4.4.11 to 4.4.17 after testing in
accordance with 5.2.2.

8
 IS/ISO 9170-1 : 2008

4.4.11 * Pressure drop

The pressure drop across the terminal unit and its probe, measured at the test pressures and with the test
flows given in Table 1, shall not exceed the values given in Table 1.

For terminal units for supply and disposal of nitrogen or air for driving surgical tools, the pressure drop across
the outlet assembly shall not exceed the value given in Table 1; the pressure drop across the inlet assembly
shall not exceed 25 kPa with a back pressure not exceeding 15 kPa.

The test for pressure drop is given in 5.3.

Table 1 — Requirements for flow and pressure drop across terminal units with probe inserted

Terminal unit nominal Test pressure Test flow Maximum pressure drop
distribution pressure across a terminal unit
kPa kPa l/min kPa
400 to 500 320 40 15
400 to 500 320 200 70
700 to 1 000 560 350 70
Vacuum 40 a 25 15
a Absolute pressure.

NOTE The values in Table 1 are in accordance with the requirements in 7.2.1, 7.2.2, 7.2.3, 7.2.4 and Table 2 of
ISO 7396-1:2007 and 4.4.14 of ISO 5359:—.

4.4.12 Connection force and torque

The force and the torque required to insert and lock the probe into the terminal unit shall be:

a) an axial force not exceeding 100 N and/or

b) a torque not exceeding 1 N⋅m.

The test for connection force and torque is given in 5.4.

4.4.13 Disconnection force and torque

4.4.13.1 The force and the torque required to release the locking mechanism shall be:

a) a push or pull of not more than 110 N and not less than 20 N and/or

b) a torque of not more than 1 N⋅m and not less than 0,1 N⋅m.

4.4.13.2 When all locking provisions have been released, according to the manufacturer’s instructions,
disconnection of the probe from the terminal unit shall require a force of not more than 100 N.

4.4.13.3 The test for disconnection force and torque is given in 5.5.

NOTE Danger to personnel can arise as a result of the rapid expulsion of probes from terminal units. The design
should prevent this from occurring.

4.4.14 Mechanical strength

The terminal unit shall withstand the application of a steady axial tensile force of not less than 500 N.

The test for mechanical strength is given in 5.6.

9
IS/ISO 9170-1 : 2008

4.4.15 Leakage

4.4.15.1 The leakage from a terminal unit with and without the probe inserted shall not exceed
0,296 ml/min (which is equivalent to 0,03 kPa⋅l/min).

The test for leakage is given in 5.7.1 and 5.7.2.

4.4.15.2 The leakage from a terminal unit with the probe inserted and with a side force applied shall not
exceed 0,296 ml/min (which is equivalent to 0,03 kPa⋅l/min).

The test for leakage is given in 5.7.3.

4.4.16 Gas specificity

The terminal unit shall only accept the probe for the gas for which it is intended.

The test for gas specificity is given in 5.8.

4.4.17 Effective connection of probes

A tactile and/or audible indication of locking shall be perceived on retention of the gas-specific probe.

The test for effective connection of probes is given in 5.9.

4.4.18 Electrical requirements

If required by regional or national regulations, terminal units shall be fitted with means for connection to an
equipotential bonding installation.

NOTE 1 Regional or national regulations which apply to electrical installations in medical locations might exist.

NOTE 2 Annex C lists some regional and national regulations for electrical installations.

4.5 Constructional requirements

4.5.1 Cleaning

Terminal units for all services shall be cleaned to meet the requirements of ISO 15001.

Evidence shall be provided by the manufacturer upon request.

NOTE Regional or national regulations might require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.

4.5.2 Lubricants

If lubricants are used, they shall be compatible with oxygen, the other medical gases and their mixtures in the
temperature range specified in 4.3.2.

Evidence shall be provided by the manufacturer upon request.

NOTE Regional or national regulations might require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.

10
 IS/ISO 9170-1 : 2008

5 Test methods

5.1 General

These are type tests.

5.1.1 Ambient conditions

Except where otherwise stated, tests shall be carried out at ambient conditions.

5.1.2 Test gas

All positive pressure tests shall be carried out with clean, oil-free, dry air or nitrogen. Tests shall be carried out
with dry gas with a maximum moisture content of 50 µg/g corresponding to a dew point of −48 °C at
atmospheric pressure.

Tests for the pressure drop across terminal units for vacuum using the apparatus shown in Figure 3 shall use
ambient air.

5.1.3 Reference conditions

Flowrates shall be corrected to 23 °C and 101,3 kPa.

5.2 Test for endurance

5.2.1 Socket

Fix the terminal unit to be tested to a horizontal or vertical surface, as appropriate, using the procedure
recommended by the manufacturer. Apply a test pressure at the inlet to the base block of the terminal unit.
Use a test pressure of 1 200 kPa for terminal units for nitrogen or air for driving surgical tools, a test pressure
of 600 kPa for all other terminal units for compressed gases or a test pressure of 60 kPa absolute for vacuum.

Using a test probe made of corrosion-resistant steel of minimum chromium content of 17 % and a surface
Brinell hardness of 210 HBW 1/30 (in accordance with ISO 6506-1), connect and release the probe
10 000 times at a frequency of not more than 10 operations per minute, with the seals being changed every
1 000 operations or according to the manufacturer’s instructions, whichever is the greater interval.

Test the socket for compliance with 4.4.11 to 4.4.17.

5.2.2 Probe

Fix a terminal unit complying with this part of ISO 9170 to a horizontal or vertical surface, as appropriate,
using the procedure recommended by the manufacturer. Apply a test pressure at the inlet to the base block of
the terminal unit. Use a test pressure of 1 200 kPa for terminal units for nitrogen or air for driving surgical tools,
a test pressure of 600 kPa for all other terminal units for compressed gases or a test pressure of 60 kPa
absolute for vacuum.

Connect and release the probe 10 000 times at a frequency of not more than 10 operations per minute, with
the seals being changed every 1 000 operations or according to the manufacturer’s instructions, whichever is
the greater interval.

Test the probe for compliance with 4.4.11 to 4.4.17.

11
IS/ISO 9170-1 : 2008

5.3 Test for pressure drop

Using an apparatus of typical configuration as shown in Figure 2 for terminal units for compressed medical
gases, Figure 3 for terminal units for vacuum or Figure 4 for terminal units for supply and disposal of nitrogen
or air for driving surgical tools, set the test pressure and flow at the inlet of the terminal unit to the appropriate
values given in Table 1 and in 4.4.11.

Measure the pressure drop across the terminal unit with the probe inserted.

For terminal units for the supply and disposal of nitrogen or air for driving surgical tools, measure the pressure
drops across the outlet and inlet assemblies simultaneously.

Key
1 pressure-differential measuring device 5 terminal unit with probe inserted
2 pressure gauge 6 flow control valve
3 pressure regulator 7 pressure supply
4 flowmeter

Figure 2 — Typical apparatus for measuring pressure drop across a terminal unit
for compressed medical gases

Key
1 pressure-differential measuring device 5 terminal unit with probe inserted
2 pressure gauge 6 flow control valve
3 vacuum regulator 7 vacuum supply
4 flowmeter

Figure 3 — Typical apparatus for measuring pressure drop across a terminal unit for vacuum

12
 IS/ISO 9170-1 : 2008

Key
1 pressure-differential measuring device
2 pressure gauge
3 pressure regulator
4 flowmeter
5 inlet assembly of terminal unit with probe inserted
6 flow control valve
7 pressure supply
8 outlet assembly of terminal unit with probe inserted
9 connection between supply and disposal sides of probe

Figure 4 — Typical apparatus for measuring pressure drop across a terminal unit for supply
and disposal of nitrogen or air for driving surgical tools

5.4 Test for connection force and torque

Adapt a probe to accommodate a suitable measuring device. Fix the terminal unit to a horizontal or vertical
surface, as appropriate, using the procedure recommended by the manufacturer.

Apply a test pressure at the inlet to the base block of the terminal unit. Use a test pressure of 1 200 kPa for
terminal units for nitrogen or air for driving surgical tools, a test pressure of 600 kPa for all other terminal units
for compressed gases or a test pressure of 60 kPa absolute for vacuum.

In accordance with the manufacturer’s instructions, insert the adapted probe into the terminal unit and record
the force and/or torque required to insert and lock the probe.

13
IS/ISO 9170-1 : 2008

5.5 Test for disconnection force and torque

Adapt a probe to accommodate a suitable measuring device.

Fix the terminal unit to a horizontal or vertical surface, as appropriate, using the procedure recommended by
the manufacturer.

Apply a test pressure at the inlet to the base block of the terminal unit. Use a test pressure of 640 kPa for
terminal units for nitrogen or air for driving surgical tools, a test pressure of 320 kPa for all other terminal units
for compressed gases or a test pressure of 40 kPa absolute for vacuum.

Insert the adapted probe into the terminal unit in accordance with the manufacturer's instructions and ensure
that it is fully engaged.

Release the locking mechanism and disconnect the probe in accordance with the manufacturer's instructions
and record the force and/or torque required to release each locking mechanism. If the recommended
disconnection method involves applying, for example, a compressive force to reduce the effort required to
disengage the locking mechanism, measure each separate force/torque involved.

5.6 Test for mechanical strength

Adapt a blanked probe in order to apply tensile force.

Fix the terminal unit to a suitable surface using the procedure recommended by the manufacturer.

Apply a test pressure at the inlet to the base block of the terminal unit. Use a test pressure of 1 200 kPa for
terminal units for nitrogen or air for driving surgical tools, a test pressure of 600 kPa for all other terminal units
for compressed gases or a test pressure of 60 kPa absolute for vacuum.

Insert the adapted probe.

Apply a tensile force of 500 N and hold it for 1 min.

Remove the tensile force, check that the terminal unit is completely functional and the leakage is in
accordance with 4.4.15.

Dismantle the terminal unit and check that no damage or distortion has occurred to either the terminal unit
components or the probe.

5.7 Test for leakage

5.7.1 Fix the terminal unit to a horizontal or vertical surface, as appropriate, using the procedure
recommended by the manufacturer.

Apply a test pressure at the inlet of the base block of the terminal unit. Use the following test pressures:

a) 320 kPa and 600 kPa for terminal units for compressed medical gases;

b) 560 kPa and 1 200 kPa for terminal units for nitrogen or air for driving surgical tools;

c) 10 kPa and 60 kPa absolute for vacuum.

Measure the leakage under the conditions of maximum test pressure and minimum test pressure.

5.7.2 Keep the terminal unit pressurized as described in 5.7.1 and insert a gas-specific blanked probe.
Measure the leakage under the conditions of maximum and minimum test pressures.

5.7.3 Apply a force of 20 N perpendicular to the long axis of the probe, 50 mm from the outermost surface
of the terminal unit. Measure the leakage whilst the force is applied to the probe under the conditions of
maximum and minimum test pressures.

14
 IS/ISO 9170-1 : 2008

5.8 Test for gas specificity

Carry out the test by attempting to connect gas-specific test probes for all other medical gases, in turn, to the
gas-specific connection point of each socket.

5.9 Test for effective connection of probes

Carry out the test by inserting the gas-specific probe and checking that a tactile and/or audible indication of
locking is perceived.

5.10 Test for durability of markings and colour coding

Rub the markings and colour coding by hand, without undue pressure, first for 15 s with a cloth rag soaked
with distilled water, then for 15 s with a cloth rag soaked with ethanol and then for 15 s with a cloth rag soaked
with isopropanol. Carry out this test at ambient temperature. Verify that the markings required in 6.1 and 6.2
are still legible.

6 Marking, colour coding and packaging

6.1 Marking

6.1.1 Terminal units, probes and their gas-specific components shall be durably and legibly marked with the
symbol of the relevant gas in accordance with Table 2.

The test for the durability of markings is given in 5.10.

NOTE In addition to the symbol, the name of the gas can be used.

6.1.2 The height of the lettering shall be at least 2,5 mm.

6.1.3 Terminal units and probes shall be marked with the manufacturer’s name or identification mark and, if
applicable, with additional means to ensure traceability such as type, batch or serial number or year of
manufacture.

Table 2 — Symbols and colour coding for medical gases

Medical gas or mixture Symbol Colour coding a, b

Oxygen O2 White
Oxygen-enriched air
Nitrous oxide N2O Blue
Medical air Air c Black-White
Air for driving surgical tools Air – 800 c Black-White
Air for driving surgical tools (with disposal) Air motor c Black-White
Nitrogen for driving surgical tools N2 – 800 Black
Carbon dioxide CO2 Grey
Oxygen/nitrous oxide mixture 50 %/50 %
O2/N2O White-blue
(by volume)
Vacuum Vac c Yellow
a According to ISO 32, except vacuum.
b An example of yellow is given by NCS 0060Y in SS 01 92 02.
c National languages may be used for air and vacuum.

15
IS/ISO 9170-1 : 2008

6.2 Colour coding

6.2.1 If colour coding is used, it shall be in accordance with Table 2 or the appropriate regional or national
standard.

6.2.2 Colour coding shall be durable.

The test for the durability of colour coding is given in 5.10.

6.3 Packaging

6.3.1 Terminal units, gas-specific probes and spare parts shall be sealed to protect against particulate
contamination and packaged to prevent damage during storage and transportation.

6.3.2 Packages shall provide a means of identification of the contents.

7 Information to be supplied by the manufacturer

7.1 Terminal units shall be accompanied by a technical description; instructions for use, storage and
transportation; and an address to which the operator can refer.

7.2 The manufacturer shall provide instructions for installation and a reference to the testing procedures for
terminal units given in ISO 7396-1.

7.3 Instructions for use shall include information necessary for the operation of the terminal unit in
accordance with its specification and shall include a description of the procedure for connection and
disconnection of probes. Instructions for use shall give detailed instructions for cleaning, inspection and
preventive maintenance to be performed by the operator or by authorized persons, and shall recommend the
frequency of such activities. A list of recommended spare parts shall be provided.

7.4 Particular attention shall be given to the following safety-related items:

⎯ the danger of fire or explosion due to the use of lubricants not recommended by the manufacturer;

⎯ the range of operating pressures;

⎯ the hazard due to the use of improper probes.

16
 IS/ISO 9170-1 : 2008

Annex A
(informative)

Rationale

This annex provides a rationale for some requirements of this part of ISO 9170 and is intended for those who
are familiar with the subject of this document but who have not participated in its development. An
understanding of the rationale underlying these requirements is considered to be essential for their proper
application. Furthermore, as clinical practice and technology change, it is believed that a rationale will facilitate
any revision of this part of ISO 9170 necessitated by those developments.

The following correspond to clauses and subclauses marked with an asterisk (*) in this part of ISO 9170. The
numbering is, therefore, not consecutive.

A.2 Only dated references are used in this part of ISO 9170. As stated in the preamble of the European
Medical Device Directive 93/42/EEC, manufacturers shall take account of technology and practice existing at
the time of design, and of technical and economical considerations compatible with a high level of protection
of health and safety. This is to ensure that a manufacturer does not design against a moving target (i.e. a
standard that is revised after completion of the specification), before the device is placed on the market.
Having only dated references will ensure that design specifications are developed using clearly defined
standards that reflect the generally acknowledged state of the art at the time of design, except for emerging
hazards requiring amendment of existing standards.

SG1 of the Global Harmonization Task Force (GHTF) (www.ghtf.org) is developing a guideline, SG1/N044[13],
which addresses the need to use dated references.

A.4.2 Attention is drawn to ISO 14971 on risk management and to the International Standards under
development by ISO/TC 210 on risk evaluation and risk control.

A.4.3.1 Terminal units for different gases are often made with interchangeable components or
subassemblies. The requirement for compatibility with oxygen should therefore be applied to terminal units for
all gases.

A.4.4.1.8, A.4.4.1.9 The testing of vacuum pipeline systems given in ISO 7396-1 requires exposure of
vacuum terminal units to a positive pressure of 500 kPa for 5 min as a test of mechanical integrity.

A.4.4.11 Lung ventilators can require peak flows of 200 l/min for up to 3 s. Experience shows that such
ventilators can be supplied by terminal units that meet the requirements of 4.4.11.

17
IS/ISO 9170-1 : 2008

Annex B
(informative)

Environmental aspects

Planning and design of products applying to this part of ISO 9170 should consider the environmental impact
from the product during its life cycle. The environmental impact generated by terminal units for use with
compressed medical gases and vacuum is mainly restricted to the following occurrences:

⎯ impact at local environment caused by leakage;

⎯ impact at local environment caused by cross-connection;

⎯ the danger of fire or explosion due to the use of unsuitable materials or lubricants;

⎯ cleaning.

To highlight the importance of reducing the environmental burden, this part of ISO 9170 addresses
requirements or recommendations intended to decrease environmental impact caused by those aspects.

See Table B.1 for a mapping of the life cycle of a terminal unit for use with compressed medical gases and
vacuum to aspects of the environment.

Table B.1 — Environmental aspects addressed by clauses of this part of ISO 9170

Product life cycle

Distribution (including Use

Environmental aspects Production and packaging) End of life
(inputs and outputs) preproduction Stage B Stage C
Stage A Stage D
Addressed in
Addressed in Clause
subclause

1 Resource Use — — — —
2 Energy consumption — — — —
3 Emissions to air 4.4.5
4.4.7
— — —
4.4.15
4.4.17
4 Emissions to water — — — —
5 Waste — — —
6 Noise — — — —
7 Migration of hazardous 4.3
— — —
substances
8 Impacts on soil — — — —
9 Risks to the environment from 6 4.1
accidents or misuse 7 4.2
4.3
4.4.1
— —
4.4.5
4.4.6
4.4.15
4.5

18
 IS/ISO 9170-1 : 2008

Annex C
(informative)

Special national and regional conditions for electrical installations

The following table provides some of the known country- and market-specific electrical installation
requirements. For the countries in which the relevant regional or national condition applies, the provisions
shown below are normative, for other countries they are informative.

Country or region Relevant regulations

Europe IEC 60364-7-710, Ed. 1[14]
Australia AS/NZS 3000[15], AS/NZS 3003[16]
USA National Electric Code
Canada Canadian Electrical Code
Japan Japanese Industrial Standard

19
IS/ISO 9170-1 : 2008

Bibliography

[1] ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary

[2] ISO 9170-2:2008, Terminal units for medical gas pipeline systems — Part 2: Terminal units for
anaesthetic gas scavenging systems

[3] DIN 13260-2:2004, Supply systems for medical gases — Part 2: Dimensions and allocation of probes
and gas-specific connection points for terminal units for compressed medical gases and vacuum

[4] ENV 737-6:2003, Medical gas pipeline systems — Part 6: Dimensions and allocation of probes for
terminal units for compressed medical gases and vacuum

[5] AS 2896-1998, Medical gas systems — Installation and testing of non-flammable medical gas pipeline
systems

[6] AS 2902-2005, Medical gas systems — Low pressure flexible hose assemblies

[7] NFPA 99:2005, Health Care Facilities

[8] UNI 9507:2004 Impianti di distribuzione di gas per uso medico — Unità terminali ed innesti (Medical
gas pipeline systems — Terminal units and connectors)

[9] CAN/CSA-Z9170-1:2005, Terminal units for medical gas pipeline systems — Part 1: Terminal units for
use with compressed medical gases and vacuum

[10] SS 875 24 30:2004, Medical gas pipeline systems — Connectors for medical gases

[11] NF S 90-116, Matériel médico-chirurgical — Prises murales et fiches correspondantes pour fluides
médicaux (Medico-surgical equipment — Terminal units and related probes for medical fluids)

[12] CGA V-5:2005, Diameter index safety system (Non-interchangeable low pressure connections for
medical gas applications)

[13] SG1/N044, Role of Standards in the Assessment of Medical Devices

[14] IEC 60364-7-710:2002, Electrical installations of buildings — Part 7-710: Requirements for special
installations or locations — Medical locations

[15] AS/NZS 3000:2000, Electrical installations (known as the Australian/New Zealand Wiring Rules)

[16] AS/NZS 3003:2003, Electrical installations — Patient treatment areas of hospitals and medical, dental
practices and dialyzing locations

20
 IS/ISO 9170-1 : 2008

NATIONAL ANNEX A
(National Foreword)

A-1 BIS CERTIFICATION MARKING

The product may also be marked with the Standard Mark.

A-1.1 The use of the Standard Mark is governed by the provisions of the Bureau of Indian Standards
Act, 1986 and the Rules and Regulations made thereunder. The details of conditions under which the
licence for the use of the Standard Mark may be granted to manufacturers or producers may be
obtained from the Bureau of Indian Standards.

21
(Continued from second cover)

In this adopted standard, reference appears to certain International Standards for which Indian
Standards also exist. The corresponding Indian Standards which are to be substituted in their respective
places are listed below along with their degree of equivalence for the editions indicated:

International Standard Corresponding Indian Standard Degree of Equivalence

ISO 32 : 1977 Gas cylinders for IS 3933 : 1966 Colour identification Technically Equivalent
medical use — Marking for of gas cylinders and related equip-
identification of content ment intended for medical use
ISO 6506-1 : 2005 Metallic materials IS 1500 : 2005 Method for brinell do
— Brinell hardness test — Part 1: hardness test for metallic materials
Test method (third revision)
ISO 7396-1 : 2007 Medical gas IS/ISO 7396-1 : 2007 Medical gas Identical
pipeline systems — Part 1: Pipelines pipeline systems: Part 1 Pipelines for
for compressed medical gases and compressed medical gases and
vacuum vacuum
ISO 15001 : 2003 Anaesthetic and IS/ISO 15001 : 2003 Anaesthetic and do
respiratory equipment — respiratory equipment — Compatibil-
Compatibility with oxygen ity with oxygen

The technical committee has reviewed the provisions of the following International Standards referred
in this adopted standard and has decided that they are acceptable for use in conjunction with this
standard:
International Standard Title
ISO 5359 : 2008 Low-pressure hose assemblies for use with medical gases
ISO 14971 : 2007 Medical devices — Application of risk management to medical devices

The standard also makes a reference to the BIS Certification Marking of the product, details of which
is given in National Annex A.

For the purpose of deciding whether a particular requirement of this standard is complied with, the
final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in
accordance with IS 2 : 1960 ‘Rules for rounding off numerical values (revised)’. The number of
significant places retained in the rounded off value should be the same as that of the specified value
in this standard.
Bureau of Indian Standards

BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promote
harmonious development of the activities of standardization, marking and quality certification of goods
and attending to connected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of these publications may be reproduced in any form
without the prior permission in writing of BIS. This does not preclude the free use, in course of imple-
menting the standard, of necessary details, such as symbols and sizes, type or grade designations.
Enquiries relating to copyright be addressed to the Director (Publications), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are also
reviewed periodically; a standard along with amendments is reaffirmed when such review indicates that
no changes are needed; if the review indicates that changes are needed, it is taken up for revision. Users
of Indian Standards should ascertain that they are in possession of the latest amendments or edition by
referring to the latest issue of ‘BIS Catalogue’ and ‘Standards: Monthly Additions’.

This Indian Standard has been developed from Doc No.: MHD 11 (0042).

Amendments Issued Since Publication

______________________________________________________________________________________
Amendment No. Date of Issue Text Affected
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________

BUREAU OF INDIAN STANDARDS

Headquarters:
Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi 110002
Telephones: 2323 0131, 2323 3375, 2323 9402 Website: www.bis.org.in

Regional Offices: Telephones

Central : Manak Bhavan, 9 Bahadur Shah Zafar Marg
NEW DELHI 110002 { 2323 7617
2323 3841
Eastern : 1/14, C.I.T. Scheme VII M, V.I.P. Road, Kankurgachi
KOLKATA 700054 { 2337 8499, 2337 8561
2337 8626, 2337 9120
Northern : SCO 335-336, Sector 34-A, CHANDIGARH 160022
{ 260 3843
260 9285
Southern : C.I.T. Campus, IV Cross Road, CHENNAI 600113
{ 2254 1216, 2254 1442
2254 2519, 2254 2315
Western : Manakalaya, E9 MIDC, Marol, Andheri (East)
MUMBAI 400093 { 2832 9295, 2832 7858
2832 7891, 2832 7892

Branches: AHMEDABAD. BANGALORE. BHOPAL. BHUBANESHWAR. COIMBATORE. DEHRADUN.

FARIDABAD. GHAZIABAD. GUWAHATI. HYDERABAD. JAIPUR. KANPUR. LUCKNOW.
NAGPUR. PARWANOO. PATNA. PUNE. RAJKOT. THIRUVANATHAPURAM. VISAKHAPATNAM.
Published by BIS, New Delhi