BS EN ISO 7396-2-2007 Medical gas pipeline systems Anaesthetic gas scavenging disposal systems《医用气体管道系统 麻醉用气体净化处理系统》.pdf

1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58disposal systemsThe European Standard EN ISO 7396-2:2007 has the status of a British StandardICS 11

2、.040.10Medical gas pipeline systems Part 2: Anaesthetic gas scavenging BRITISH STANDARDBS EN ISO 7396-2:2007Incorporating corrigendum no. 1BS EN ISO 7396-2:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2007 BSI 2007ISBN 978 0 580

3、 50763 2Amendments issued since publicationAmd. No. Date Comments17199 Corrigendum No. 131 July 2007 Change to supersession detailsThis publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Stan

4、dard cannot confer immunity from legal obligations.National forewordThis British Standard is the UK implementation of EN ISO 7396-2:2007. It supersedes BS EN 737-2:1998 which will be withdrawn on 30 April 2009.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaes

5、thetic and respiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems.A list of organizations represented on this subcommittee can be obtained on request to its secretary.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 7396-2April 2007ICS 11.040.10 Supersedes EN 737-2:1998 Eng

6、lish VersionMedical gas pipeline systems - Part 2: Anaesthetic gasscavenging disposal systems (ISO 7396-2:2007)Rseaux de distribution de gaz mdicaux - Partie 2:Rseaux dvacuation de gaz danesthsie non rutilisables(ISO 7396-2:2007)Rohrleitungssysteme fr medizinische Gase - Teil 2:Entsorgungssysteme vo

7、n Ansthesiegas-Fortleitungssystemen (ISO 7396-2:2007)This European Standard was approved by CEN on 15 March 2007.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 alt

8、eration. 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 tran

9、slationunder 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,

10、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 STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagemen

11、t Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 7396-2:2007: EForeword This document (EN ISO 7396-2:2007) has been prepared by Technical Committee CEN/TC 215 “Respiratory and ana

12、esthetic equipment“, the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the la

13、test by October 2007, and conflicting national standards shall be withdrawn at the latest by October 2007. This document supersedes EN 737-2:1998. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential r

14、equirements of EU Directive(s). For relationship with EU Directive(s), 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 Standar

15、d: 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. EN ISO

16、 7396-2:2007Reference numberISO 7396-2:2007(E)INTERNATIONAL STANDARD ISO7396-2Second edition2007-04-01Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems Rseaux de distribution de gaz mdicaux Partie 2: Rseaux dvacuation de gaz danesthsie non rutilisables EN ISO 7396-2:20

17、07ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements. 6 4.1 Safety . 6 4.2 Alternative construction 6 4.3 Materials 6 4.4 Continuity of operation 7 5 Power device . 7 6 Indicating systems 8 7 Pipelines, connecting a

18、ssemblies and disposal hoses 8 8 Disposal system characteristics and test methods for pressure and flow 9 8.1 Requirements 9 8.2 Test methods for pressure and flow. 10 8.3 Means to prevent backflow 12 9 Terminal units . 12 10 Marking and colour coding 12 10.1 Marking 12 10.2 Colour coding 13 10.3 Te

19、st for durability 13 11 Pipeline installation 13 12 Testing, commissioning and certification 15 12.1 General. 15 12.2 General requirements for tests . 15 12.3 Tests, inspections and checks 15 12.4 Requirements for tests, inspections and checks listed in 12.3 . 15 12.5 Certification of the system. 16

20、 12.6 Extensions or modifications 17 13 Information to be supplied by the manufacturer. 17 13.1 General. 17 13.2 Instructions for use 17 13.3 Operational management information 18 13.4 “As-installed” drawings . 18 13.5 Electrical diagrams. 18 Annex A (informative) Guidelines for power devices consis

21、ting of fans, blowers or dedicated vacuum pumps 19 Annex B (informative) Example of procedure for testing and commissioning 20 Annex C (informative) Typical forms for certification of AGS disposal systems 23 Annex D (informative) Risk management checklist 36 Annex E (informative) Rationale . 44 Bibl

22、iography . 45 EN ISO 7396-2:2007iv 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 in

23、terested 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 Electrotechni

24、cal 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

25、 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.

26、 ISO shall not be held responsible for identifying any or all such patent rights. ISO 7396-2 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in collaboration with Technical Committee ISO/TC 121, Anaesthetic and r

27、espiratory equipment, Subcommittee SC 6, Medical gas systems, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). This second edition cancels and replaces the first edition (ISO 7396-2:2000), which has been technically revised. ISO 7396 consists of the f

28、ollowing parts, under the general title Medical gas pipeline systems: Part 1: Pipeline systems for compressed medical gases and vacuum Part 2: Anaesthetic gas scavenging disposal systems EN ISO 7396-2:2007vIntroduction Anaesthetic gas scavenging systems (AGSS) are used to reduce occupational exposur

29、e to anaesthetic gases and vapours. The anaesthetic gas scavenging system comprises three main parts: a transfer system, a receiving system, and a disposal system. A schematic diagram of typical anaesthetic gas scavenging systems is shown in Figure 1. Requirements for receiving systems and transfer

30、systems are specified in ISO 8835-3. Type-specific connections for terminal units are specified in ISO 9170-2. In this part of ISO 7396, specifications and test procedures are given to ensure compatibility between the components of the system. This part of ISO 7396 specifies requirements for pipelin

31、es for anaesthetic gas scavenging systems for anaesthetic gases and vapours. It is intended for use by those persons involved in the design, construction, inspection and operation of healthcare facilities treating human beings. It is advisable that those persons involved in the design, manufacture a

32、nd testing of equipment intended to be connected to pipeline systems also be aware of the contents of this part of ISO 7396. Specific components are used for scavenging terminal units and for other connectors which are intended to be used by the operator. In addition, the system is tested and certif

33、ied to operate at safe flows and without leakage. It is also intended to address issues of patient safety. The objectives of this part of ISO 7396 are to ensure the following: a) avoidance of cross connections between different pipeline systems; b) continuity of function of the system; c) use of sui

34、table materials; d) cleanliness of components; e) correct installation; f) provision of indicating system(s); g) correct marking of the pipeline system and components; h) testing, commissioning and certification; i) correct operational management. Annex E contains rationale statements for some of th

35、e requirements of this part of ISO 7396. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this part of ISO 7396. The clauses and subclauses marked with (*) after their number have corresponding rationale c

36、ontained in Annex E. EN ISO 7396-2:2007blank1Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems 1 Scope This part of ISO 7396 specifies requirements for the design, installation, function, performance, documentation, testing and commissioning of anaesthetic gas scavengi

37、ng disposal systems to ensure patient safety and to minimize exposure of the operator and other persons to anaesthetic gases and vapours. It includes requirements for the power device, pipeline system, performance, non-interchangeability between key components and avoidance of cross connections betw

38、een anaesthetic gas scavenging (AGS) disposal systems and medical gas and vacuum pipeline systems. NOTE In this part of ISO 7396, the term “pipeline” refers exclusively to pipelines that are part of a dedicated anaesthetic gas scavenging system (AGSS). This part of ISO 7396 is applicable only to tho

39、se disposal systems intended to be connected via AGSS terminal units conforming to ISO 9170-2 and to AGSS receiving systems conforming to ISO 8835-3. This part of ISO 7396 also applies to: extensions of existing AGSS disposal systems; modifications of existing AGSS disposal systems; modifications or

40、 replacement of power devices. 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) appl

41、ies. ISO 5359, Low-pressure hose assemblies for use with medical gases ISO 7396-1:2007, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 8835-3:1), Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scave

42、nging systems ISO 9170-2, Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging systems 1) To be published. (Revision of ISO 8835-3:1997.) EN ISO 7396-2:20072 ISO 14971, Medical devices Application of risk management to medical devices ISO 15001, Anaes

43、thetic and respiratory equipment Compatibility with oxygen EN 1041, Information supplied by the manufacturer with medical devices EN 13348, Copper and copper alloys Seamless, round copper tubes for medical gases or vacuum 3 Terms and definitions For the purposes of this document, the following terms

44、 and definitions apply. 3.1 AGSS socket female part of a terminal unit which is either integral or attached to the base block by a type-specific interface, and which contains the type-specific connection point 3.2 AGSS terminal unit inlet assembly in an AGSS at which the operator makes connections a

45、nd disconnections 3.3 AGSS terminal unit base block part of an AGSS terminal unit which is attached to the pipeline disposal system 3.4 AGSS type 1 terminal unit connection point between the receiving system and the disposal system at which an operator makes connections and disconnections See Figure

46、 1. 3.5 AGSS type 1H terminal units AGSS type 1 terminal unit to be used in high-flow disposal systems 3.6 AGSS type 1L terminal units AGSS type 1 terminal unit to be used in low-flow disposal systems 3.7 AGSS type 2 terminal unit connection point between the power device or the disposal hose and th

47、e remainder of the disposal system at which an operator makes connections and disconnections See Figure 1. 3.8 AGSS type-specific having characteristics which prevent interchangeability and thereby allow assignment to one AGSS type only 3.9 AGSS type-specific connection point part of the AGSS socket

48、 which is the receptor for an AGSS type-specific probe EN ISO 7396-2:200733.10 air compressor system source of supply with compressor(s) designed to provide medical air and/or air for driving surgical tools and/or air for AGSS NOTE Different names or symbols are used for air for driving surgical too

49、ls, such as: instrument air, surgical air, air motor, air - 700 and air - 800. 3.11 anaesthetic gas scavenging system AGSS complete system which is connected to the exhaust port(s) of a breathing system or other equipment for the purpose of conveying expired and/or excess anaesthetic gases and vapours to an appropriate point of discharge NOTE Functionally, an AGSS comprises three different parts: a transfer system, a receiving system and a disposal system. These three functionally discrete