1、July 2007DEUTSCHE NORM English price group 20No 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; 23.040.01!,z#+
2、“9870008www.din.deDDIN EN ISO 7396-2Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)English version of DIN EN ISO 7396-2:2007-07Rohrleitungssysteme fr medizinische Gase Teil 2: Entsorgungssysteme von Ansthesiegas-Fortleitungssystemen (ISO 7396-2:2007
3、)Englische Fassung DIN EN ISO 7396-2:2007-07SupersedesDIN EN 737-2:2000-01www.beuth.deDocument comprises 55 pages 09.07DIN EN ISO 7396-2:2007-07 2 National foreword This standard has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kin
4、gdom) in collaboration with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment”, Subcommittee SC 6 “Medical gas systems” (Secretariat: ANSI, USA). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Ho
5、spital Standards Committee), Technical Committee 053-03-06 Zentrale Gasversorgungsanlagen. Users of this standard are granted the right to duplicate the forms given in Annex C. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN s
6、hall not be held responsible for identifying any or all such patent rights. DIN EN ISO 7396 consists of the following 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 The
7、DIN Standards corresponding to the International Standard referred to in clause 2 and in the bibliography of the EN are as follows: ISO 4135 DIN EN ISO 4135 ISO 5359 DIN EN ISO 5359 ISO 7396-1 DIN EN ISO 7396-1 ISO 8835-3 DIN EN ISO 8835-3 ISO 9170-2 DIN EN ISO 9170-2 ISO 14971 DIN EN ISO 14971 ISO
8、15001 DIN EN ISO 15001 Amendments This standard differs from DIN EN 737-2:2000-01 as follows: a) The standard now also includes specifications for the operational management of anaesthetic gas scavenging disposal systems. b) A distinction has been drawn between AGSS type 1 terminal units to be used
9、in high-flow disposal systems and those to be used in low-flow disposal systems. c) Material requirements have been specified. d) Specifications for continuity of operation have been added. e) Requirements for locations of power devices have been specified. f) The requirements for pipeline installat
10、ion have been revised. g) General requirements for testing, commissioning and certification have been specified. h) Requirements for extensions of or modifications to the system have been specified. i) Information to be supplied by the manufacturer is now included. DIN EN ISO 7396-2:2007-07 3 j) A n
11、ew informative Annex D covering risk management has been included. k) The standard has been editorially revised. Previous editions DIN EN 737-2: 1996-06, 2000-01 National Annex NA (informative) Bibliography DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 5359, Low-pressu
12、re hose assemblies for use with medical gases DIN EN ISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum DIN EN ISO 8835-3, Inhalational anaesthesia systems Anaesthetic gas scavenging systems Part 3: Transfer and receiving systems of active anaes
13、thetic gas scavenging systems DIN EN ISO 9170-2, Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging systems DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15001, Anaesthetic and respiratory equipment C
14、ompatibility with oxygen DIN EN ISO 7396-2:2007-07 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 7396-2April 2007ICS 11.040.10 Supersedes EN 737-2:1998 English VersionMedical gas pipeline systems - Part 2: Anaesthetic gasscavenging disposal systems (ISO 739
15、6-2:2007)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 von Ansthesiegas-Fortleitungssystemen (ISO 7396-2:2007)This European Standard was approved by CEN on 15
16、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 alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obta
17、ined 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 to the CEN Manageme
18、nt 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, Netherlands, Norway, P
19、oland, 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 2007 CEN All rights of exploitation in any form and by a
20、ny means reservedworldwide for CEN national Members.Ref. No. EN ISO 7396-2:2007: EContents Page Foreword Introduction 1 Scope . 2 Normative references . 3 Terms and definitions. 8 8.2 Test methods for pressure and flow. 8.3 Means to prevent backflow 9 Terminal units . 10 Marking and colour coding 10
21、.1 Marking 10.2 Colour coding 10.3 Test for durability 11 Pipeline installation 12 Testing, commissioning and certification 12.1 General. 12.2 General requirements for tests . 12.3 Tests, inspections and checks 12.4 Requirements for tests, inspections and checks listed in 12.3 . 12.5 Certification o
22、f the system. 12.6 Extensions or modifications13 Information to be supplied by the manufacturer.13.1 General.13.2 Instructions for use 13.3 Operational management information13.4 “As-installed” drawings .13.5 Electrical diagrams.Annex A (informative) Guidelines for power devices consisting of fans,
23、blowers or dedicated vacuum pumps Annex B (informative) Example of procedure for testing and commissioning Annex C (informative) Typical forms for certification of AGS disposal systems Annex D (informative) Risk management checklistAnnex E (informative) Rationale .Bibliography .2 Annex ZA (informati
24、ve) Relationship between this International Standard and the Essential 50 EN ISO 7396-2:2007 (E) 4556101010 10 1111 1212 13 1314 16 17. 34 General requirements.4.1 Safety .4.2 Alternative construction 4.3 Materials 4.4 Continuity of operation 5 Power device .6 Indicating systems7 Pipelines, connecti
25、ng assemblies and disposal hosesDisposal system characteristics and test methods for pressure and flow 8.1 Requirements 1616161717192122 23 24 274048 491919191921212122 22 20 Requirements of EU Directive 93/42/EEC on Medical devices 3 EN ISO 7396-2:2007 (E) Foreword This document (EN ISO 7396-2:2007
26、) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC121 “Anaesthetic and respiratory equipment”. This European Standard shall be given the status of a national standard
27、, either by publication of an identical text or by endorsement, at the latest by October 2007, and conflicting national standards shall be withdrawn at the latest by April 2009. This document supersedes EN 737-2:1998. This document has been prepared under a mandate given to CEN by the European Commi
28、ssion and the European Free Trade Association, and supports essential requirements 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
29、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, Sl
30、ovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Introduction Anaesthetic gas scavenging systems (AGSS) are used to reduce occupational exposure to anaesthetic gases and vapours. The anaesthetic gas scavenging system comprises three main parts: a transfer system, a receiving system,
31、and a disposal system. A schematic diagram of typical anaesthetic gas scavenging systems is shown in Figure 1. Requirements for receiving systems and transfer 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, spec
32、ifications and test procedures are given to ensure compatibility between the components of the system. This part of ISO 7396 specifies requirements for pipelines for anaesthetic gas scavenging systems for anaesthetic gases and vapours. It is intended for use by those persons involved in the design,
33、construction, inspection and operation of healthcare facilities treating human beings. It is advisable that those persons involved in the design, manufacture and testing of equipment intended to be connected to pipeline systems also be aware of the contents of this part of ISO 7396. Specific compone
34、nts 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 certified 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
35、 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 suitable materials; d) cleanliness of components; e) correct installation; f) provision of indicating system(s); g) correct marking of the pipel
36、ine system and components; h) testing, commissioning and certification; i) correct operational management. Annex E contains rationale statements for some of the requirements of this part of ISO 7396. It is included to provide additional insight into the reasoning that led to the requirements and rec
37、ommendations that have been incorporated in this part of ISO 7396. The clauses and subclauses marked with (*) after their number have corresponding rationale contained in Annex E. 4 EN ISO 7396-2:2007 (E) 1 Scope This part of ISO 7396 specifies requirements for the design, installation, function, pe
38、rformance, documentation, testing and commissioning of anaesthetic gas scavenging 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-in
39、terchangeability between key components and avoidance of cross connections between 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 anaestheti
40、c gas scavenging system (AGSS). This part of ISO 7396 is applicable only to those 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 disp
41、osal systems; modifications of existing AGSS disposal systems; modifications or 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
42、, the latest edition of the referenced document (including any amendments) applies. 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
43、 systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging 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.) 5 EN ISO 7396-2:2007 (E) ISO 14971
44、, Medical devices Application of risk management to medical devices ISO 15001, Anaesthetic 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 v
45、acuum 3 Terms and definitions For the purposes of this document, the following terms 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 AG
46、SS terminal unit inlet assembly in an AGSS at which the operator makes connections and 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
47、disposal system at which an operator makes connections and disconnections See Figure 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
48、 terminal unit connection point between the power device or the disposal hose and the 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 t
49、o one AGSS type only 3.9 AGSS type-specific connection point part of the AGSS socket which is the receptor for an AGSS type-specific probe 6 EN ISO 7396-2:2007 (E) 3.10 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 tools, such as: instrument air, surgical air, air motor, air - 700 and air - 800. 3.11 anaesthetic gas scavenging system AGSS complete
