SIST EN ISO 9170-1:2020

SLOVENSKI STANDARD
SIST EN ISO 9170-1:2020
01-september-2020
Nadomešča:
SIST EN ISO 9170-1:2008
Končni deli napeljav za medicinske pline - 1. del: Končni deli za stisnjene
medicinske pline in podtlak (ISO 9170-1:2017)
Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with
compressed medical gases and vacuum (ISO 9170-1:2017)
Entnahmestellen für Rohrleitungssysteme für medizinische Gase - Teil 1:
Entnahmestellen für medizinische Druckgase und Vakuum (ISO 9170-1:2017)
Prises murales pour systèmes de distribution de gaz médicaux - Partie 1: Prises murales
pour les gaz médicaux comprimés et le vide (ISO 9170-1:2017)
Ta slovenski standard je istoveten z: EN ISO 9170-1:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9170-1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9170-1:2020

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SIST EN ISO 9170-1:2020


EN ISO 9170-1
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2020
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 9170-1:2008
English Version

Terminal units for medical gas pipeline systems - Part 1:
Terminal units for use with compressed medical gases and
vacuum (ISO 9170-1:2017)
Prises murales pour systèmes de distribution de gaz Entnahmestellen für Rohrleitungssysteme für
médicaux - Partie 1: Prises murales pour les gaz medizinische Gase - Teil 1: Entnahmestellen für
médicaux comprimés et le vide (ISO 9170-1:2017) medizinische Druckgase und Vakuum (ISO 9170-
1:2017)
This European Standard was approved by CEN on 15 April 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9170-1:2020 E
worldwide for CEN national Members.

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SIST EN ISO 9170-1:2020
EN ISO 9170-1:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 9170-1:2020
EN ISO 9170-1:2020 (E)
European foreword
This document (EN ISO 9170-1:2020) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2020, and conflicting national standards
shall be withdrawn at the latest by June 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9170-1:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 9170-1:2017 has been approved by CEN as EN ISO 9170-1:2020 without any
modification.


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SIST EN ISO 9170-1:2020

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SIST EN ISO 9170-1:2020
INTERNATIONAL ISO
STANDARD 9170-1
Third edition
2017-07
Terminal units for medical gas
pipeline systems —
Part 1:
Terminal units for use with
compressed medical gases and vacuum
Prises murales pour systèmes de distribution de gaz médicaux —
Partie 1: Prises murales pour les gaz médicaux comprimés et le vide
Reference number
ISO 9170-1:2017(E)
©
ISO 2017

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SIST EN ISO 9170-1:2020
ISO 9170-1:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

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SIST EN ISO 9170-1:2020
ISO 9170-1:2017(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 *Normative references . 2
3 Terms and definitions . 2
4 General requirements . 7
4.1 Safety . 7
4.2 *Alternative construction . 7
4.3 Materials . 7
5 Design requirements . 8
5.1 Medical gas supply . 8
5.2 Terminal units for different pressures . 9
5.3 Retention of gas specificity . 9
5.4 Gas-specific connection point . 9
5.5 Terminal unit check valve . 9
5.6 Terminal unit maintenance valve . 9
5.7 Connection of terminal units to the pipeline (see also 9.2) .10
5.8 Socket .10
5.9 Compliance .10
5.10 Endurance (connection/release) .10
5.10.1 Socket .10
5.10.2 Probe .10
5.11 *Pressure drop .10
5.12 Connection force and torque .11
5.13 Disconnection force and torque .11
5.14 Mechanical strength .11
5.15 Leakage .12
5.16 Gas specificity .12
5.17 Effective connection of probes .12
5.18 Electrical requirements .12
6 Constructional requirements .12
6.1 Cleaning .12
6.2 Lubricants .12
7 Test methods .12
7.1 General .12
7.2 Test for endurance .13
7.3 Test for pressure drop .13
7.4 Test for connection force and torque .15
7.5 Test for disconnection force and torque .15
7.6 Test for mechanical strength .16
7.7 Test for leakage .16
7.8 Test for gas specificity .17
7.9 Test for effective connection of probe .17
7.10 Test for durability of markings and colour coding .17
8 Marking, colour coding and packaging .17
8.1 Marking .17
8.2 Colour coding .17
8.3 Packaging .18
9 Information to be supplied by the manufacturer .18
9.1 Technical description .18
9.2 Instructions .18
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SIST EN ISO 9170-1:2020
ISO 9170-1:2017(E)

Annex A (informative) Rationale .19
Annex B (informative) Environmental aspects .20
Annex C (informative) Special national and regional conditions for electrical installations .22
Bibliography .24
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SIST EN ISO 9170-1:2020
ISO 9170-1:2017(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 on the voluntary nature of standards, the meaning of ISO specific terms and
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 the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC6, Medical gas systems.
This third edition cancels and replaces the second edition (ISO 9170-1:2008), which has been technically
revised.
This edition includes the following significant changes with respect to the previous edition:
a) oxygen 93, detailing marking and colour coding, was introduced;
b) figures for test conditions were clarified.
A list of all parts in the ISO 9170 series can be found on the ISO website.
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SIST EN ISO 9170-1:2020
ISO 9170-1:2017(E)

Introduction
Terminal units are the points on a 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. Terminal units are also used for vacuum pipeline systems. 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
requirements specified in this document.
This document pays particular attention to
— suitability of materials,
— gas-specificity,
— cleanliness,
— testing,
— identification, and
— information supplied.
This document contains information for the installation and 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 in accordance with ISO 7396-1 has been completed.
Annex A contains rationale statements for some of the requirements of this document. 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 document. It is considered that knowledge of the
reasons for the requirements will not only facilitate the proper application of this document, but will
also expedite any subsequent revisions.
Annex B contains environmental aspects that should be considered.
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SIST EN ISO 9170-1:2020
INTERNATIONAL STANDARD ISO 9170-1:2017(E)
Terminal units for medical gas pipeline systems —
Part 1:
Terminal units for use with compressed medical gases
and vacuum
1 Scope
This document is intended especially to ensure the gas-specific assembly, mechanical resistance, flow,
leakage and pressure drop of terminal units and to prevent their interchange between different gases
and services and applies to terminal units:
a) intended for use in medical gas pipeline systems in accordance with ISO 7396-1;
b) used as pressure outlets on pressure regulators in accordance with ISO 10524-1;
c) used as pressure outlets on pressure regulators integrated with cylinder valves (VIPR) in
accordance with ISO 10524-3.
This document applies to terminal units for use with the following gases for administration to patients
or for medical uses (A):
— oxygen (A);
— nitrous oxide (A);
— medical air (A);
— carbon dioxide (A);
— oxygen/nitrous oxide mixture (A);
— helium/oxygen mixtures (A);
— oxygen 93 (A);
— gases and gas mixtures classified as medical device (A);
— gases delivered to medical devices or intended for medical purposes (A);
— gases and gas mixtures for medicinal use not specified above (A).
This document applies to terminal units for use with the following gases (B):
— air for driving surgical tools (B);
— nitrogen for driving surgical tools (B).
This document applies to terminal units for use with vacuum systems (C).
NOTE The requirements of this document can be used as guidelines for terminal units for other gases. These
other gases will be considered for inclusion in this document when they come into general use.
This document specifies requirements for terminal units for supply and disposal of nitrogen and air for
driving surgical tools.
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ISO 9170-1:2017(E)

This document specifies requirements for probes intended to be connected to the gas-specific
connection point.
This document does not specify the dimensions of probes or of the gas-specific connection points.
NOTE Regional or national standards specifying dimensions of probes and gas-specific connection points
are given in the Bibliography.
Other connection systems in national use may be acceptable under this document. Dimensioning for
such connections will be specified by their respective national standards.
This document does not specify the requirements for terminal units for anaesthetic gas scavenging
systems (AGSS), which are specified in ISO 9170-2.
2 *Normative references
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.
ISO 32, Gas cylinders for medical use — Marking for identification of content
ISO 5359:2014, Low-pressure hose assemblies for use with medical gases
ISO 6506-1, Metallic materials — Brinell hardness test — Part 1: Test method
ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
ISO 11114-3, Transportable gas cylinders — Compatibility of cylinder and valve materials with gas contents
— Part 3: Autogenous ignition test in oxygen atmosphere
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
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 or vacuum services
3.3
gas-specific connection point
part of the socket which is the receptor for a gas-specific probe
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ISO 9170-1:2017(E)

3.4
gas-specific connector
connector with dimensional characteristics that prevent connections between different gas services
Note 1 to entry: Examples of gas-specific connectors are quick connectors (3.14), screw-threaded connectors,
diameter-index safety system (DISS) connectors (3.1), non-interchangeable screw-threaded (NIST) connectors (3.11)
or sleeve indexed (SIS) connectors (3.16).
3.5
low-pressure hose assembly
assembly consisting of a flexible hose with permanently attached gas-specific inlet and outlet
connectors and designed to conduct a medical gas (3.7) at pressures less than 1 400 kPa and vacuum
3.6
medical device gas
any gas or mixture of gases intended by the manufacturer to be used for human beings for the purpose of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
Note 1 to entry: In Europe, these gases are classified as a medical device in accordance with Directive 93/42/EC.
3.7
medical gas
any gas or mixture of gases having properties for treating or preventing disease in human beings which
may be used in or administered either with a view to restore, correct or modify physiological functions
by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis
Note 1 to entry: This is also sometimes referred to as medicinal gas.
Note 2 to entry: In Europe, this is classified as a medicinal product in accordance with Directive 2001/83/EC.
3.8
medical gas pipeline system
complete system which comprises a supply system, a monitoring and alarm system and a distribution
system with terminal units at the points where medical gases (3.7) or vacuum may be required
3.9
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 (3.7) supply
source complete with pressure regulator(s)
3.10
nominal distribution pressure
pressure which the medical gas pipeline system (3.8) is intended to deliver at the terminal units
Note 1 to entry: Unless otherwise specified, pressures in this document are expressed as gauge pressures
(i.e. atmospheric pressure is defined as 0 kPa gauge pressure).
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3.11
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
3.12
pressure regulator integrated with cylinder valve
VIPR
combination of a pressure regulator and cylinder valve intended to be fitted to a medical gas (3.7)
cylinder
3.13
probe
gas-specific male component designed for acceptance by and retention in the socket
3.14
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
3.15
single-fault condition
condition in which a single means for pro
...