SIST 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)
Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)
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. It is intended especially to ensure the gas-specific assembly of terminal units and to prevent their interchange between different gases and services. This part of ISO 9170 specifies requirements for terminal units for supply and disposal of nitrogen or air for driving surgical tools. 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. This part of ISO 9170 does not specify the dimensions of probes or of the gas-specific connection points of the terminal units. This part of ISO 9170 does not specify the dimensions of NIST connectors, which are defined in ISO 5359. This part of ISO 9170 does not specify the dimensions of DISS connectors, which are defined in CGA V-51) [ 12]. This part of ISO 9170 does not specify the requirements f or terminal units for anaesthetic gas scavenging systems (AGSS ), which are covered in ISO 9170-2.
Entnahmestellen für Rohrleitungssysteme für medizinische Gase - Teil 1: Entnahmestellen für medizinische Druckgase und Vakuum (ISO 9170-1:2008)
1.1 Dieser Teil von ISO 9170 gilt für
a) Entnahmestellen, die in Rohrleitungssystemen für medizinische Gase nach ISO 7396 1 zur Verwendung mit den folgenden medizinischen Gasen vorgesehen sind:
- Sauerstoff;
- mit Sauerstoff angereicherte Luft;
- Distickstoffoxid (Lachgas);
- medizinische Luft;
- Kohlendioxid;
- Sauerstoff /Lachgasgemische [50 %/50 % (Volumenanteil)];
b) Entnahmestellen, die in Rohrleitungssystemen für medizinische Gase nach ISO 7396 1 zur Verwendung mit den folgenden Gasen und Versorgungen vorgesehen sind:
- Luft zum Betreiben chirurgischer Werkzeuge;
- Stickstoff zum Betreiben chirurgischer Werkzeuge;
- Vakuum.
ANMERKUNG 1 Medizinische Luft kann durch Luftkompressorsysteme oder Gasmischersysteme hergestellt werden (siehe ISO 7396-1).
ANMERKUNG 2 Für Luft zum Betreiben chirurgischer Werkzeuge werden verschiedene Bezeichnungen und Symbole verwendet, wie zum Beispiel Luft für Instrumente, chirurgische Luft, Luftmotor, Air-700 und Air-800.
ANMERKUNG 3 Die Anforderungen in diesem Teil von ISO 9170 dürfen als Anleitung für Entnahmestellen für sonstige Gase verwendet werden. Diese Gase werden zur Aufnahme in diesen Teil von ISO 9170 berücksichtigt, wenn sie allgemein gebräuchlich werden.
Es ist vor allem beabsichtigt, die gasartspezifische Montage von Entnahmestellen sicherzustellen und zu verhindern, dass diese zwischen unterschiedlichen Gasen vertauscht werden.
1.2 Dieser Teil von ISO 9170 legt Anforderungen an Entnahmestellen für die Bereitstellung und Entsorgung von Stickstoff oder Luft zum Betreiben chirurgischer Werkzeuge fest.
1.3 Dieser Teil von ISO 9170 legt Anforderungen an Stecker zum Anschluss an die gasartspezifische Verbin¬dungsstelle fest, die Teil der Entnahmestelle ist.
1.4 Dieser Teil von ISO 9170 legt nicht die Maße von Steckern und von gasartspezifischen Verbindungs¬stellen der Entnahmestellen fest.
ANMERKUNG Regionale oder nationale Normen, die Maße von Steckern und gasartspezifischen Verbindungsstellen festlegen,
Prises murales pour systèmes de distribution de gaz médicaux - Partie 1: Prises murales pour les gaz médicaux comprimés et le vide (ISO 9170-1:2008)
L'ISO 9170-1:2008 est applicable aux
prises murales destinées à être utilisées dans les systèmes de distribution de gaz médicaux conformément à l'ISO 7396-1, conçus pour être utilisés avec les gaz médicaux suivants:
oxygène;
protoxyde d'azote;
air médical;
dioxyde de carbone;
mélanges d'oxygène et de protoxyde d'azote [50 %/50 % (fraction volumique)];
prises murales destinées à être utilisées dans les systèmes de distribution de gaz médicaux conformément à l'ISO 7396-1, conçus pour être utilisés avec les gaz et services suivants:
air enrichi en oxygène;
air moteur pour les instruments chirurgicaux;
azote moteur pour les instruments chirurgicaux;
vide.
Elle est notamment destinée à garantir le montage spécifique au gaz des prises murales et à en empêcher l'interchangeabilité entre les différents gaz.
L'ISO 9170-1:2008 spécifie les exigences relatives aux prises murales d'arrivée et d'évacuation d'azote ou d'air pour les instruments chirurgicaux, ainsi que les exigences relatives aux embouts destinés à être branchés au raccord spécifique au gaz faisant partie d'une prise murale.
Končni deli napeljav za medicinske pline - 1. del: Končni deli za stisnjene medicinske pline in podtlak (ISO 9170-1:2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9170-1:2008
01-september-2008
1DGRPHãþD
SIST EN 737-1:2000
.RQþQLGHOLQDSHOMDY]DPHGLFLQVNHSOLQHGHO .RQþQLGHOL]DVWLVQMHQH
PHGLFLQVNHSOLQHLQSRGWODN ,62
Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with
compressed medical gases and vacuum (ISO 9170-1:2008)
Entnahmestellen für Rohrleitungssysteme für medizinische Gase - Teil 1:
Entnahmestellen für medizinische Druckgase und Vakuum (ISO 9170-1:2008)
Prises murales pour systèmes de distribution de gaz médicaux - Partie 1: Prises murales
pour les gaz médicaux comprimés et le vide (ISO 9170-1:2008)
Ta slovenski standard je istoveten z: EN ISO 9170-1:2008
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9170-1:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 9170-1:2008
---------------------- Page: 2 ----------------------
SIST EN ISO 9170-1:2008
EUROPEAN STANDARD
EN ISO 9170-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2008
ICS 11.040.10 Supersedes EN 737-1:1998
English Version
Terminal units for medical gas pipeline systems - Part 1:
Terminal units for use with compressed medical gases and
vacuum (ISO 9170-1:2008)
Prises murales pour systèmes de distribution de gaz Entnahmestellen für Rohrleitungssysteme für medizinische
médicaux - Partie 1: Prises murales pour les gaz médicaux Gase - Teil 1: Entnahmestellen für medizinische Druckgase
comprimés et le vide (ISO 9170-1:2008) und Vakuum (ISO 9170-1:2008)
This European Standard was approved by CEN on 21 June 2008.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9170-1:2008: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 9170-1:2008
EN ISO 9170-1:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative) Correspondence between this International Standard and Directive
93/42/EEC.4
2
---------------------- Page: 4 ----------------------
SIST EN ISO 9170-1:2008
EN ISO 9170-1:2008 (E)
Foreword
This document (EN ISO 9170-1:2008) 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 January 2009, and conflicting national standards shall be withdrawn at
the latest by July 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 737-1:1998.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directives, see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 9170-1:2008 has been approved by CEN as a EN ISO 9170-1:2008 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 9170-1:2008
EN ISO 9170-1:2008 (E)
Annex ZA
(informative)
Correspondence between this International Standard and
Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC Medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a
presumption of conformity with the corresponding Essential Requirements of that Directive and associated
EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clause(s)/Sub-clause(s) of Corresponding essential requirements Qualifying remarks/Notes
this International Standard of EU Directive 93/42/EEC
4 1
4.1 2, 6
4.2 2
4.3 2
4.3.1 7.1, 7.3, 9.3
4.3.2 4, 7.1, 9.2
4.3.3 3, 5
4.3.4 7.1, 7.2
4.3.5 7.3, 9.3
4.4 2, 3, 4
4.4.1 9.1, 9.2
4.4.1.2 12.7.1
4.4.1.5 12.7.1
4.4.1.8 12.7.1
4.4.2 9.1, 12.7.4
4.4.3 12.7.4
4.4.4 9.1, 12.7.4
4.4.5 12.8.2
4.4.6 12.8.2
4.4.7 9.1, 12.7.4
4.4.8 12.7.4
4.4.10 12.7.4
4
---------------------- Page: 6 ----------------------
SIST EN ISO 9170-1:2008
EN ISO 9170-1:2008 (E)
Table ZA.1 (continued)
Clause(s)/Sub-clause(s) of Corresponding essential requirements Qualifying remarks/Notes
this International Standard of EU Directive 93/42/EEC
4.4.11 9.1
4.4.12 9.2, 12.7.4
4.4.13 9.2, 12.7.4
4.4.14 9.2, 12.7.1, 12.7.4
4.4.15 7.5
4.4.16 9.1, 12.7.4
4.4.17 9.1, 12.7.4
4.4.18 12.6
4.5.1 7.2, 9.3
4.5.2 7.3, 9.3
5.2 12.7.4
5.3 9.1
5.4 9.2, 12.7.4
5.5 9.2, 12.7.4
5.6 9.2, 12.7.1, 12.7.4
5.7 7.5
5.8 9.1, 12.7.4
5.9 9.1, 12.7.4
5.10 13.2
6.1 13.2
6.1.3 13.1, 13.3 a), 13.3 d), 13.5
6.2 13.2
6.3 3, 5
6.3.1 5, 7.2, 7.6
6.3.2 13.1, 13.3 b)
7.1 13.1, 13.3 a), 13.4, 13.6 a)
7.2 7.6, 9.1, 12.7.4, 13.6 c), 13.6 d)
7.3 2, 13.1
7.4 1st dash 9.3
7.4 2nd dash 9.2
7.4 3rd dash 9.1, 12.7.4, 13.6 c)
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
5
---------------------- Page: 7 ----------------------
SIST EN ISO 9170-1:2008
---------------------- Page: 8 ----------------------
SIST EN ISO 9170-1:2008
INTERNATIONAL ISO
STANDARD 9170-1
Second edition
2008-07-01
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 9170-1:2008(E)
©
ISO 2008
---------------------- Page: 9 ----------------------
SIST EN ISO 9170-1:2008
ISO 9170-1:2008(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2008
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2008 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 9170-1:2008
ISO 9170-1:2008(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 * Normative references .2
3 Terms and definitions .2
4 General requirements .6
4.1 Safety.6
4.2 * Alternative construction.6
4.3 Materials .6
4.4 Design requirements.7
4.5 Constructional requirements .10
5 Test methods .11
5.1 General .11
5.2 Test for endurance .11
5.3 Test for pressure drop .12
5.4 Test for connection force and torque.13
5.5 Test for disconnection force and torque .14
5.6 Test for mechanical strength .14
5.7 Test for leakage .14
5.8 Test for gas specificity.15
5.9 Test for effective connection of probes.15
5.10 Test for durability of markings and colour coding .15
6 Marking, colour coding and packaging.15
6.1 Marking.15
6.2 Colour coding .16
6.3 Packaging.16
7 Information to be supplied by the manufacturer .16
Annex A (informative) Rationale.17
Annex B (informative) Environmental aspects .18
Annex C (informative) Special national and regional conditions for electrical installations.19
Bibliography.20
© ISO 2008 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 9170-1:2008
ISO 9170-1:2008(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 9170-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
This second edition cancels and replaces the first edition (ISO 9170-1:1999) which has been technically
revised.
ISO 9170 consists of the following parts, under the general title Terminal units for medical gas pipeline
systems:
⎯ Part 1: Terminal units for use with compressed medical gases and vacuum
⎯ Part 2: Terminal units for anaesthetic gas scavenging systems
iv © ISO 2008 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 9170-1:2008
ISO 9170-1:2008(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. 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 part of ISO 9170.
This part of ISO 9170 pays particular attention to:
⎯ suitability of materials;
⎯ gas specificity;
⎯ cleanliness;
⎯ testing;
⎯ identification;
⎯ information supplied.
This part of ISO 9170 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 in accordance with ISO 7396-1 has been completed.
Annex A contains rationale statements for some of the requirements of this part of ISO 9170. 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 part of ISO 9170, but will expedite any
subsequent revisions.
© ISO 2008 – All rights reserved v
---------------------- Page: 13 ----------------------
SIST EN ISO 9170-1:2008
---------------------- Page: 14 ----------------------
SIST EN ISO 9170-1:2008
INTERNATIONAL STANDARD ISO 9170-1:2008(E)
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.
© ISO 2008 – All rights reserved 1
---------------------- Page: 15 ----------------------
SIST EN ISO 9170-1:2008
ISO 9170-1:2008(E)
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
1) [12]
CGA V-5 .
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
2)
ISO 5359:— , 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 © ISO 2008 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 9170-1:2008
ISO 9170-1:2008(E)
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
© ISO 2008 – All rights reserved 3
---------------------- Page: 17 ----------------------
SIST EN ISO 9170-1:2008
ISO 9170-1:2008(E)
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 © ISO 2008 – All rights reserved
---------------------- Page: 18 ----------------------
SIST EN ISO 9170-1:2008
ISO 9170-1:2008(E)
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
© ISO 2008 – All rights reserved 5
---------------------- Page: 19 ----------------------
SIST EN ISO 9170-1:2008
ISO 9170-1:2008(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.
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.