EN ISO 9170-1:2020

Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2017)

ISO 9170-1:2017 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.
ISO 9170-1:2017 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).
ISO 9170-1:2017 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.
ISO 9170-1:2017 specifies requirements for terminal units for supply and disposal of nitrogen and air for driving surgical tools.
ISO 9170-1:2017 specifies requirements for probes intended to be connected to the gas-specific connection point.
ISO 9170-1:2017 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.
ISO 9170-1:2017 does not specify the requirements for terminal units for anaesthetic gas scavenging systems (AGSS), which are specified in ISO 9170‑2.

Entnahmestellen für Rohrleitungssysteme für medizinische Gase - Teil 1: Entnahmestellen für medizinische Druckgase und Vakuum (ISO 9170-1:2017)

Dieses Dokument soll insbesondere die gasartspezifische Montage, die mechanische Festigkeit, Durchfluss,
Leckage und Druckabfall von Entnahmestellen sicherstellen und verhindern, dass diese zwischen
unterschiedlichen Gasen und Versorgungen vertauscht werden, und es gilt für folgende Entnahmestellen:
a) Entnahmestellen für Rohrleitungssysteme für medizinische Gase nach ISO 7396-1;
b) Entnahmestellen, die bei Druckminderern nach ISO 10524-1 als Druckausgang verwendet werden;
c) Entnahmestellen, die bei Druckminderern in Flaschenventilen (VIPR, en: valve with integrated pressure regulator) nach ISO 10524-3 als Druckausgang verwendet werden.
Dieses Dokument gilt für Entnahmestellen zur Verwendung mit den folgenden Gasen, die zur Abgabe an den Patienten oder für medizinische Zwecke vorgesehen sind (A):
- Sauerstoff (A);
- Distickstoffoxid (Lachgas) (A);
- medizinische Luft (A);
- Kohlendioxid (A);
- Sauerstoff-/Distickstoffoxidgemische (A);
- Helium-/Sauerstoffgemische (A);
- Sauerstoff 93 (A);
- Gase und Gasgemische, die als Medizinprodukt klassifiziert sind (A);
- Gase, die an Medizinprodukte abgegeben werden oder für medizinische Zwecke vorgesehen sind (A);
- Gase und Gasgemische zur Verwendung als Arzneimittel, die nicht in der obigen Aufzählung enthalten sind (A).
Dieses Dokument gilt für Entnahmestellen zur Verwendung mit den folgenden Gasen (B):
- Luft zum Betreiben chirurgischer Werkzeuge (B);
- Stickstoff zum Betreiben chirurgischer Werkzeuge(B).
Dieses Dokument gilt für Entnahmestellen zur Verwendung in Vakuumsystemen (C).
ANMERKUNG 1 Die Anforderungen in diesem Dokument können als Anleitung für Entnahmestellen für sonstige Gase verwendet werden. Diese sonstigen Gase werden zur Aufnahme in diesem Dokument berücksichtigt, wenn sie allgemein gebräuchlich werden.
Dieses Dokument legt Anforderungen an Entnahmestellen für die Bereitstellung und Entsorgung von Stickstoff oder Luft zum Betreiben chirurgischer Werkzeuge fest.
Dieses Dokument legt Anforderungen an Stecker fest, die zum Anschluss an die gasartspezifische Verbindungsstelle vorgesehen sind.
Dieses Dokument legt nicht die Maße von Steckern und von gasartspezifischen Verbindungsstellen fest.
ANMERKUNG 2 Regionale und nationale Normen, die Maße von Steckern und gasartspezifischen Verbindungsstellen festlegen, sind in den Literaturhinweisen aufgeführt.
Andere Verbindungssysteme, die national verwendet werden, sind nach diesem Dokument akzeptabel. Die Maße für derartige Verbindungen werden in entsprechenden nationalen Normen festgelegt.
Dieses Dokument legt nicht die Anforderungen an Entnahmestellen für Anästhesiegas-Fortleitungssysteme (AGFS) fest, die in ISO 9170-2 festgelegt sind.

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)

ISO 9170-1:2017 est notamment destiné à garantir le montage spécifique au gaz, la résistance mécanique, l'écoulement, l'absence de fuite et de chute de pression des prises murales et à en empêcher l'interchangeabilité entre les différents gaz et services. Elle s'applique aux prises murales:
a)    destinées à être utilisées dans les systèmes de distribution de gaz médicaux conformément à l'ISO 7396‑1;
b)    utilisées comme raccords de sortie en pression sur les détendeurs conformément à l'ISO 10524‑1;
c)    utilisées comme raccords de sortie en pression sur les détendeurs intégrés aux robinets de bouteille (VIPR) conformément à l'ISO 10524‑3.
ISO 9170-1:2017 s'applique aux prises murales destinées à être utilisées avec les gaz suivants, dans le cadre d'une administration aux patients ou pour des usages médicaux (A):
-      l'oxygène (A);
-      le protoxyde d'azote (A);
-      l'air médical (A);
-      le dioxyde de carbone (A);
-      le mélange d'oxygène et de protoxyde d'azote (A);
-      les mélanges d'hélium et d'oxygène (A);
-      l'oxygène 93 (A);
-      les gaz et les mélanges de gaz classés en tant que dispositif médical (A);
-      les gaz fournis à des dispositifs médicaux ou ceux destinés à des usages médicaux (A);
-      les gaz et les mélanges de gaz destinés à un usage médical non spécifié ci-dessus (A).
Le présent document s'applique aux prises murales destinées à être utilisées avec les gaz suivants (B):
-      l'air servant à faire fonctionner les instruments chirurgicaux (B);
-      l'azote servant à faire fonctionner les instruments chirurgicaux (B).
Le présent document s'applique aux prises murales destinées à être utilisées avec les réseaux de vide (C).
NOTE          Les exigences du présent document peuvent être utilisées comme lignes directrices pour les prises murales relatives à d'autres gaz. Ces autres gaz seront pris en compte pour être inclus dans le présent document lorsque leur utilisation sera généralisée.
ISO 9170-1:2017 spécifie les exigences relatives aux prises murales d'arrivée et d'évacuation d'azote ou d'air pour les instruments chirurgicaux.
ISO 9170-1:2017 Le présent document spécifie les exigences relatives aux embouts destinés à être branchés au raccord spécifique au gaz.
ISO 9170-1:2017 ne spécifie pas les dimensions des embouts et des raccords spécifiques au gaz.
NOTE          Certaines normes régionales ou nationales spécifiant les dimensions des embouts et des raccords spécifiques au gaz sont données dans la Bibliographie.
D'autres systèmes de raccordement utilisés à l'échelle nationale peuvent être acceptables en vertu du présent document. Les dimensions de ces raccordements sont spécifiées par leurs normes nationales respectives.
ISO 9170-1:2017 ne spécifie pas les exigences relatives aux prises murales pour les systèmes d'évacuation de gaz d'anesthésie (SEGA), qui sont couvertes par l'ISO 9170‑2.

Končni deli napeljav za medicinske pline - 1. del: Končni deli za stisnjene medicinske pline in podtlak (ISO 9170-1:2017)

General Information

• Status: Published
• Publication Date: 16-Jun-2020
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 17-Jun-2020
• Completion Date: 17-Jun-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 9170-1:2020 - Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2017)

Relations

• Replaces: EN ISO 9170-1:2008 - Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)
• Effective Date: 17-Sep-2014

Overview

EN ISO 9170-1:2020 (ISO 9170-1:2017) specifies requirements for terminal units for medical gas pipeline systems intended for use with compressed medical gases and vacuum. It focuses on ensuring gas-specific assembly, mechanical resistance, flow performance, leakage limits and acceptable pressure drop, and preventing interchange between different gases and services. The standard applies to terminal units used in hospital piping systems, pressure outlets on pressure regulators (ISO 10524-1) and regulators integrated with cylinder valves (VIPR, ISO 10524-3).

Key topics and requirements

• Scope of gases covered: oxygen, nitrous oxide, medical air, carbon dioxide, oxygen/nitrous oxide mixtures, helium/oxygen mixtures, oxygen 93, medical-device-classified gases, and other gases for medical use. Also covers air and nitrogen for driving surgical tools and vacuum systems.
• Gas specificity and retention: mechanical and design measures to prevent cross-connection between different gases and services.
• Flow and pressure performance: requirements and test methods for pressure drop and flow performance through terminal units.
• Mechanical strength and endurance: tests for connection/disconnection cycles, connection/disconnection forces and torques, and overall mechanical robustness.
• Leakage control: acceptable leakage limits and test procedures to verify sealing integrity.
• Probe compatibility: requirements for probes intended to connect to gas-specific connection points (note: the standard does not specify probe or socket dimensions - national/regional standards may do so).
• Marking, colour coding and packaging: durable markings and colour codes to identify gas service and ensure safety.
• Test methods and documentation: standardized tests for endurance, pressure drop, leakage, gas specificity and instructions/technical information to be supplied by the manufacturer.
• Exclusions: requirements for anaesthetic gas scavenging systems (AGSS) are covered by ISO 9170‑2, not this part.

Practical applications and users

• Hospitals and healthcare facilities: specification and procurement of wall outlets, terminal units and vacuum sockets for central medical gas systems.
• Manufacturers of terminal units, probes and pressure regulators: design, testing and certification to meet mechanical, flow and safety requirements.
• Medical gas system designers and installers: selecting compliant terminal units that match pipeline standards and prevent cross-connection.
• Facilities engineers and maintenance teams: verifying endurance, leakage and marking during installation, routine testing and replacement.
• Regulators and compliance bodies: referencing the standard (adopted as EN ISO 9170-1:2020 by CEN) for national adoption and conformity assessment.

Related standards

• ISO 7396-1 - medical gas pipeline systems
• ISO 10524-1 - pressure regulators (outlets)
• ISO 10524-3 - VIPR (regulators integrated with cylinder valves)
• ISO 9170-2 - terminal units for anaesthetic gas scavenging systems (AGSS)

Keywords: terminal units, medical gas pipeline systems, EN ISO 9170-1:2020, ISO 9170-1, compressed medical gases, vacuum, gas-specific connection, medical air, oxygen 93, pressure drop, leakage, probe compatibility.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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
ISO 9170-1:2017(E)
© 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

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
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
iv © ISO 2017 – All rights reserved

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.
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.
vi © ISO 2017 – All rights reserved

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.
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
2 © ISO 2017 – All rights reserved

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).
ISO 9170-1:2017(E)
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 protection against a safety hazard in equipment is defective or a
single external abnormal condition is present
Note 1 to entry: Planned maintenance of equipment is considered a normal condition.
3.16
sleeve index system connector
SIS connector
range of male and female components intended to maintain gas specificity by the allocation of a set of
different diameters to the mating connectors for each particular gas
3.17
socket
female part of a terminal unit (3.18) 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
3.18
terminal unit
outlet assembly (inlet for vacuum) in a medical gas pipeline system (3.8) at which the operator makes
connections and disconnections
3.19
terminal unit base block
part of a terminal unit (3.18) which is attached to the pipeline distribution system
3.20
terminal unit check valve
valve which remains closed until opened by insertion of an appropriate probe and which then permits
flow in either direction
3.21
terminal unit maintenance valve
valve that permits maintenance of the terminal unit without shutting down the pipeline system to other
terminal units
4 © ISO 2017 – All rights reserved

ISO 9170-1:2017(E)
3.22
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 (3.8) and to a gas disposal system respectively and at which the operator
makes connections and disconnections by means of a combined probe
ISO 9170-1:2017(E)
Key
1 gas-specific connector
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
6 © ISO 2017 – All rights reserved

ISO 9170-1:2017(E)
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.
A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous
situations can remain undetected over a period of time and as a consequence can lead to an unacceptable
risk. In that case, a fault condition subsequently detected needs to be considered as a single fault
condition. Specific risk control measures to deal with such situations need to be determined within the
risk management process.
Measures should be taken to minimize electrical and mechanical hazards. National or regional
regulations concerning such hazards may exist.
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 document, shall be presumed to be in compliance with the safety
objectives of this document 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 Objective evidence can be obtained by postmarket surveillance.
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.
4.3 Materials
4.3.1 Materials in contact with the gases listed in the Scope, 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 Oxygen compatibility is usually defined as the ability of a material to coexist with oxygen and a
moderate ignition source. The aim of using oxygen-compatible materials is to develop a system design which has
a low probability of ignition and low consequences based on the use of materials exhibiting good compatibility,
low energy release if ignited or by minimizing the quantities of non-metallic components.
NOTE 3 Many materials which do not burn in air will do so in an oxygen enriched atmosphere, particularly
under pressure. Similarly, materials which can be ignited in air require lower ignition energies to ignite 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 4 Design considerations and criteria for the selection of metallic and non-metallic materials are given in
ISO 15001.
4.3.2 The materials shall permit the terminal units and their components to meet the requirements of
ISO 9170-1 in the temperature range of −20 °C to +60 °C.
ISO 9170-1:2017(E)
4.3.3 Terminal units shall meet the requirements of ISO 9170-1 after being exposed, while packed for
transport and storage, to environmental conditions as specified by the manufacturer.
4.3.4 Materials that are liable to shed particles which come in contact with the medical gas in normal
condition or single-fault condition shall not be used for highly strained components and parts liable to wear.
EXAMPLE Springs.
NOTE See ISO 15001:2010, Annex C.
4.3.5 For terminal units for all gases, the auto-ignition 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 auto-ignition 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 auto-
ignition 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 auto-ignition temperature is not a
constant. Values of the auto-ignition 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 There is a possibility that regional or national regulations require the provision of evidence to a
competent authority or conformity assessment body (e.g. notified body in the European Economic Area) upon
request.
5 Design requirements
5.1 Medical gas supply
Table 1 defines the pressure requirements for terminal units in accordance with their specific
intended use.
5.1.1 Terminal units shall
— be designed to operate and meet the requirements of this document within the nominal distribution
pressure range given in Table 1,
— be designed to operate and meet the requirements of this document within the distribution pressure
range given in Table 1,
— not cause a hazard at the test pressure given in Table 1, and
— be able to withstand the test pressure given in Table 1 for 5 min and continue to meet the requirements
of this document within the distribution pressure range given in Table 1.
8 © ISO 2017 – All rights reserved

ISO 9170-1:2017(E)
Table 1 — Terminal outlet pressure requirements
Medical gas supply Nominal distribution Distribution pressure Test pressure
system pressure range range
(kPa)
(kPa) (kPa)
Pipeline and/or pressure 400 to 500 320 to 600 1 200
regulators for medical
gases (A)
Pipeline and/or pressure 700 to 1 000 560 to 1200 2 400
regulators for gases for
driving surgical tools (B)
Pipeline for vacuum –40 –90 to –40 500
(C) (60 absolute) (10 to 60 absolute)
5.1.2 Evidence of conformity with the requirements of 5.1.1 shall be provided by the manufacturer
upon request.
NOTE There is a possibility that regional or national regulations require the provision of evidence to a
competent authority or conformity assessment body (e.g. notified body in the European Economic Area) upon
request.
5.2 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 range.
5.3 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.
5.4 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.
5.5 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 5.6.
5.6 Terminal unit maintenance valve
Except for vacuum services and terminal units for the supply and disposal of nitrogen or air for driving
surgical tools, 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 5.5.
Rationale:
Terminal units for the supply and disposal of nitrogen or air for driving surgical tools do not need a
maintenance valve. Regarding the ISO 7396-1, an area shut-off valve shall be provided in each gas and
vacuum pipeline serving for each operating theatre. In the case of maintenance, the operator has to
shut off the drive gas with this area shut off valve.
ISO 9170-1:2017(E)
A leakage from the terminal unit maintenance valve is permitted provided it causes no unacceptable
risk to the operator while changing the socket under nominal distribution pressure.
Evidence shall be provided by the manufacturer upon request.
5.7 Connection of terminal units to the pipeline (see also 9.2)
5.7.1 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, DISS or SIS body) connection to a pipeline distribution
system. The connection shall comply with ISO 7396-1.
5.7.2 Connection to a low-pressure hose shall be either by direct ferruling on to a hose insert or by
means of a gas-specific connector and shall comply with ISO 5359 (see Figure 1).
5.8 Socket
The attachment of a socket to its base block shall be gas specific.
5.9 Compliance
Compliance with 5.2 to 5.8 shall be tested by visual inspection, functional testing and/or measurement.
5.10 Endurance (connection/release)
5.10.1 Socket
The socket shall retain gas specificity and meet the requirements given in Table 2 after testing in
accordance with 7.2.1.
5.10.2 Probe
The probe shall retain gas specificity and meet the requirements given in Table 2 after testing in
accordance with 7.2.2.
5.11 *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 2, shall not exceed the values given in Table 2.
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 2; 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 7.3.
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ISO 9170-1:2017(E)
Table 2 — 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 l/min
range
kPa
kPa
400 to 500 320 40 15
400 to 500 320 200 70
700 to 1 000 560 350 100
Vacuum −40 25 15
(60 absolute)
NOTE The values in Table 1 are in accordance with the requirements in ISO 7396-1:2016, 7.2.1, 7.2.2, 7.2.3,
7.2.4 and Table 2 and ISO 5359:2014, 4.4.14.
5.12 Connection force and torque
The force and the torque required to insert and lock the probe into the terminal unit shall be
a) a torque not exceeding 1 Nm, and
b) axial force according to Table 3.
Table 3 — Axial force requirements for connections
Terminal unit nominal Test pressure Maximum allowed axial
distribution pressure range connection force
kPa
kPa N
700 to 1 000 1 200 200
400 to 500 600 100
−40
Vacuum 100
(60 absolute)
The test for connection force and torque is given in 7.4.
5.13 Disconnection force and torque
5.13.1 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 Nm and not less than 0,1 Nm.
5.13.2 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.
5.13.3 The test for disconnection force and torque is given in 7.5.
NOTE Danger to personnel can arise as a result of the rapid expulsion of probes from terminal units. The
design can prevent this from occurring.
5.14 Mechanical strength
The terminal unit shall withstand the application of a steady axial tensile force of at least 500 N. The
test for mechanical strength is given in 7.6.
ISO 9170-1:2017(E)
5.15 Leakage
...