1、BRITISH STANDARDBS EN ISO 9170-1:2008Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuumICS 11.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40
2、g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 9170-1:2008This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 August 2008 BSI 2008ISBN 978 0 580 55057 7National forewordThis British Standard is the UK implementa
3、tion of EN ISO 9170-1:2008. It supersedes BS EN 737-1:1998 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems.A list of organizations represented on this c
4、ommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments/corrigenda issue
5、d since publicationDate CommentsEUROPEAN 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 for use with compressed medical gases andvacuum (ISO 9170-1:2008)Prises m
6、urales 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 medizinische Druckgaseund Vakuum (ISO 9170-1:2008)This European Standard was a
7、pproved 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. Up-to-date lists and bibliographical references concerning such nationals
8、tandards 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 translationunder the responsibility of a CEN member into its own language and notified
9、 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Ne
10、therlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation
11、in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 9170-1:2008: EForeword 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 “Respirat
12、ory 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 l
13、atest 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 pre
14、pared 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
15、 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,
16、 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. BS EN ISO 9170-1:2008iiiContents Page Introduction.v 1 Sco
17、pe1 2 * Normative references .2 3 Terms and definitions .2 4 General requirements .6 4.1 Safety6 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
18、5.4 Test for connection force and torque13 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 specificity15 5.9 Test for effective connection of probes15 5.10 Test for durability of markings and colour coding 15 6 Marking, co
19、lour 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) Rationale17 Annex B (informative) Environmental aspects 18 Annex C (informative) Special national and regional conditions for electrical instal
20、lations19 Bibliography20 BS EN ISO 9170-1:2008Annex ZA (informative) Correspondence between this International Standardand Directive 93/42/EEC .21blankvIntroduction Terminal units are the points on a medical gas pipeline system where the operator makes connections and disconnections for the supply o
21、f 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
22、 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 installatio
23、n 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 t
24、he 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 incorporate
25、d 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. BS EN ISO 9170-1:2008blank1Terminal units for medical gas pipeline systems Part 1: Terminal un
26、its 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/ni
27、trous 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 Differe
28、nt 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
29、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
30、 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. BS EN ISO 9170-1:20082 1.4 This part of ISO 9170 does not specify the dimensions of probes or of
31、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 I
32、SO 5359. 1.6 This part of ISO 9170 does not specify the dimensions of DISS connectors, which are defined in CGA V-51) 12. 1.7 This part of ISO 9170 does not specify the requirements for terminal units for anaesthetic gas scavenging systems (AGSS), which are covered in ISO 9170-2. 2 * Normative refer
33、ences 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
34、Marking for identification of content ISO 5359:2), Low-pressure hose assemblies for use with medical gases ISO 6506-1:2005, Metallic materials Brinell hardness test Part 1: Test method ISO 7396-1:2007, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO
35、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 Comp
36、atibility 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 ra
37、nge 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.
38、2) To be published. (Revision of ISO 5359:2000) BS EN ISO 9170-1:200833.3 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
39、 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-sp
40、ecific 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 medica
41、l 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 insta
42、llation 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 p
43、art 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 rig
44、ht-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
45、one or both hands without the use of tools BS EN ISO 9170-1:20084 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 eith
46、er 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
47、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 pe
48、rmits 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
49、 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 BS EN ISO 9170-1:20085Key 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 BS EN ISO 9170-1:20086 4 General requirements 4.1 Safety Terminal units shall, when trans
