DIN 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) English version of.pdf

1、October 2008DEUTSCHE NORM English price group 15No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!$R|“1472789w

2、ww.din.deDDIN EN ISO 9170-1Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases andvacuum (ISO 9170-1:2008)English version of DIN EN ISO 9170-1:2008-10Entnahmestellen fr Rohrleitungssysteme fr medizinische Gase Teil 1: Entnahmestellen fr medizi

3、nische Druckgase und Vakuum (ISO 9170-1:2008)Englische Fassung DIN EN ISO 9170-1:2008-10SupersedesDIN EN 737-1:1998-02www.beuth.deDocument comprises 30 pagesDIN EN ISO 9170-1:2008-10 2 National foreword This standard has been published in accordance with a decision taken by CEN/TC 215 “Respiratory a

4、nd anaesthetic equipment” (Secretariat: BSI, United Kingdom) to adopt, without alteration, International Standard ISO 9170:2008 as a European Standard. ISO 9170:2008 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equip-ment” (Secretariat: ANSI, USA). The responsible

5、 German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical Committee NA 053-03-06 AA Zentrale Gasversorgungsanlagen. DIN EN ISO 9170 consists of the following parts, under the general title Terminal un

6、its 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 The DIN Standards corresponding to the International Standards referred to in clause 2 and in the bibliography of the EN are as

7、follows: ISO 4135 DIN EN ISO 4135 ISO 6506-1 DIN EN ISO 6506-1 ISO 7396-1 DIN EN ISO 7396-1 ISO 9170-2 DIN EN ISO 9170-2 ISO 11114-3 DIN EN ISO 11114-3 ISO 14971 DIN EN ISO 14971 ISO 15001 DIN EN ISO 15001 Amendments This standard differs from DIN EN 737-1:1998-02 as follows: a) In subclause 1.1, it

8、em b), oxygen-enriched air has been added. b) Specifications regarding connections to terminal units have been revised. c) Table 1 “Requirements for flow and pressure drop across terminal units with probe inserted” has been revised. d) Material requirements have been revised (4.3). e) Design require

9、ments (4.4), especially as regards the supply pressure, have been revised. f) The test methods have been revised to include requirements relating to terminal units for vacuum. g) The informative Annex relating to special national conditions (colour coding) has been deleted. h) Annex B (informative)

10、“Environmental aspects” has been added. i) The standard has been editorially revised. DIN EN ISO 9170-1:2008-10 3 Previous editions DIN 13260-2: 1984-12 DIN EN 737-1: 1998-02 National Annex NA (informative) Bibliography DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 650

11、6-1, Metallic materials Brinell hardness test Part 1: Test method DIN EN ISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum DIN EN ISO 9170-2, Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging

12、systems DIN EN ISO 11114-3:1998-06, Compatibility of transportable gas cylinder and valve materials with gas content Part 3: Autogenous ignition test in oxygen atmosphere DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15001:2004-08, Anaesthetic and res

13、piratory equipment Compatibility with oxygen DIN EN ISO 9170-1:2008-10 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 9170-1July 2008ICS 11.040.10 Supersedes EN 737-1:1998 English VersionTerminal units for medical gas pipeline systems - Part 1:Terminal units

14、 for use with compressed medical gases andvacuum (ISO 9170-1:2008)Prises murales pour systmes de distribution de gazmdicaux - Partie 1: Prises murales pour les gaz mdicauxcomprims et le vide (ISO 9170-1:2008)Entnahmestellen fr Rohrleitungssysteme fr medizinischeGase - Teil 1: Entnahmestellen fr medi

15、zinische Druckgaseund 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 EuropeanStandard the status of a national standard without any alteration.

16、 Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationu

17、nder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece,

18、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre

19、: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 9170-1:2008: EContents Page Foreword.3 Introduction 4 1 Scope .5 2 * Normative references.6 3 Terms and definitions.6 4 General requiremen

20、ts.10 4.1 Safety .10 4.2 * Alternative construction 10 4.3 Materials 10 4.4 Design requirements 11 4.5 Constructional requirements.14 5 Test methods.15 5.1 General.15 5.2 Test for endurance15 5.3 Test for pressure drop16 5.4 Test for connection force and torque.17 5.5 Test for disconnection force an

21、d torque18 5.6 Test for mechanical strength.18 5.7 Test for leakage.18 5.8 Test for gas specificity.19 5.9 Test for effective connection of probes .19 5.10 Test for durability of markings and colour coding19 6 Marking, colour coding and packaging19 6.1 Marking 19 6.2 Colour coding20 6.3 Packaging 20

22、 7 Information to be supplied by the manufacturer.20 Annex A (informative) Rationale .21 Annex B (informative) Environmental aspects22 Annex C (informative) Special national and regional conditions for electrical installations23 Annex ZA (informative) Correspondence between this International Standa

23、rd and Directive 93/42/EEC 24 Bibliography .26 2DIN EN ISO 9170-1:2008-10 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 a

24、nd 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

25、 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

26、 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 Regu

27、lations, 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, Neth

28、erlands, 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. 3DIN EN ISO 9170-1:2008-10 EN ISO 9170-1:2008 (E) Introduction

29、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 ope

30、rator. 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; clean

31、liness; 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 unit

32、s 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

33、, 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

34、 will expedite any subsequent revisions. 4DIN EN ISO 9170-1:2008-10 EN ISO 9170-1:2008 (E) 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;

35、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

36、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 gase

37、s 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 ter

38、minal 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. 5DIN EN ISO 9170-1:2008-10 EN ISO 9170-1:2008 (E) 1.4 This

39、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

40、specify the dimensions of NIST connectors, which are defined in ISO 5359. 1.6 This part of ISO 9170 does not specify the dimensions of DISS connectors, which are defined in CGA V-51) 12. 1.7 This part of ISO 9170 does not specify the requirements for terminal units for anaesthetic gas scavenging sys

41、tems (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

42、 amendments) applies. ISO 32:1977, Gas cylinders for medical use Marking for identification of content ISO 5359:2), Low-pressure hose assemblies for use with medical gases ISO 6506-1:2005, Metallic materials Brinell hardness test Part 1: Test method ISO 7396-1:2007, Medical gas pipeline systems Part

43、 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 d

44、evices 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

45、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 bet

46、ween different gas services 1) CGA = Compressed Gas Association. 2) To be published. (Revision of ISO 5359:2000) 6DIN EN ISO 9170-1:2008-10 EN 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 conne

47、ctor 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-pres

48、sure 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 the

49、rapeutic, 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 pres