DIN EN ISO 9170-2-2009 Terminal units for medical gas pipeline systems - Part 2 Terminal units for anaesthetic gas scavenging systems (ISO 9170-2 2008) English version of DIN EN IS.pdf

1、September 2009DEUTSCHE NORM English price group 14No 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!$Ya;“15462

2、24www.din.deDDIN EN ISO 9170-2Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging systems(ISO 9170-2:2008)English version of DIN EN ISO 9170-2:2009-09Entnahmestellen fr Rohrleitungssysteme fr medizinische Gase Teil 2: Entnahmestellen fr Ansthesiegas-

3、Fortleitungssysteme (ISO 9170-2:2008)Englische Fassung DIN EN ISO 9170-2:2009-09SupersedesDIN EN ISO 9170-2:2008-10www.beuth.deDocument comprises 32 pagesDIN EN ISO 9170-2:2009-09 2 National foreword This standard has been published in accordance with a decision taken by CEN/TC 215 “Respiratory and

4、anaesthetic equipment” (Secretariat: BSI, United Kingdom) to adopt, without alteration, International Standard ISO 9170-2:2008 as a European Standard. ISO 9170-2:2008 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: BSI, United Kingdom). The r

5、esponsible 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 T

6、erminal 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 The DIN Standards corresponding to the International Standards referred to in clause 2 and in the bibliography of the

7、EN are as follows: ISO 4135 DIN EN ISO 4135 ISO 6506-1 DIN EN ISO 6506-1 ISO 7396-2 DIN EN ISO 7396-2 ISO 8835-3 DIN EN ISO 8835-3 ISO 9170-1 DIN EN ISO 9170-1 ISO 14971 DIN EN ISO 14971 ISO 15001 DIN EN ISO 15001 Amendments This standard differs from DIN EN 737-4:1998-02 as follows: a) For terminal

8、 units for anaesthetic gas scavenging systems, type 1, a distinction is made between terminal units to be used in low-flow disposal systems and terminal units in high-flow disposal systems. b) The cleanliness of terminal units is required to be in accordance with the requirements of ISO 15001. c) An

9、nex B (informative) “Environmental aspects” has been added. d) The standard has been editorially revised. Compared with DIN EN ISO 9170-2:2008-10, the following corrections have been made to the German version only and therefore do not affect the English text: a) In Figure 2 “Schematic diagram of ty

10、pical anaesthetic gas scavenging systems” last example, number 11 (permanent connection) has been replaced by number 13 (flexible hose or pendant). b) Figure 3 and Figure 4 have been editorially revised. Previous editions DIN EN 737-4: 1998-02 DIN EN ISO 9170-2: 2008-10 DIN EN ISO 9170-2:2009-09 3 N

11、ational Annex NA (informative) Bibliography DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 6506-1, Metallic materials Brinell hardness test Part 1: Test method DIN EN ISO 7396-2, Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems DIN EN ISO

12、 8835-3, Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems DIN EN ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum DIN EN ISO 14971, Medical devices A

13、pplication of risk management to medical devices DIN EN ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen DIN EN ISO 9170-2:2009-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9170-2 July 2008 ICS 11.040.10 Supersedes EN 737-4:

14、1998 English Version Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) Prises murales pour systmes de distribution de gaz mdicaux - Partie 2: Prises murales pour systmes dvacuation des gaz danesthsie (ISO 9170-2:2008) En

15、tnahmestellen fr Rohrleitungssysteme fr medizinische Gase - Teil 2: Entnahmestellen fr Ansthesiegas-Fortleitungssysteme (ISO 9170-2:2008) This European Standard was approved by CEN on 15 May 2008. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condition

16、s 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 of

17、ficial 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 Austr

18、ia, 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 COMMIT

19、TEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9170-2:2008: EContents 2 DIN EN I

20、SO 9170-2:2009-09 EN ISO 9170-2:2008 (E) Page Foreword .3 Introduction.4 1 Scope5 2 * Normative references .5 3 Terms and definitions .7 4 General requirements .11 4.1 Safety11 4.2 * Alternative construction.11 4.3 Materials .11 4.4 Design requirements.11 4.5 Construction requirements 18 5 Test meth

21、ods .18 5.1 General .18 5.2 Endurance test.18 5.3 Test method for pressure drop 19 5.4 Test method for connection force .19 5.5 Test method for disconnection force19 5.6 Tests for mechanical strength .20 5.7 Tests for leakage .20 5.8 Test for type specificity 20 5.9 Test for effective connection of

22、probes to sockets .20 5.10 Test for connection of receiving or disposal hoses to hose inserts .20 5.11 Test for durability of markings and colour coding 20 6 Marking, colour coding and packaging.20 6.1 Marking.20 6.2 Colour coding 21 6.3 Packaging.21 7 Information to be supplied by the manufacturer

23、.21 Annex A (informative) Rationale22 Annex B (informative) Environmental aspects 23 Annex C (informative) Special national and regional conditions for electrical installations25 Bibliography26 Annex ZA (informative) Correspondence between this International Standard and Directive 93/42/EEC.27 3 EN

24、ISO 9170-2:2008 (E) DIN EN ISO 9170-2:2009-09 Foreword 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

25、 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 super

26、sedes EN 737-4:1998. 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 Directive, see informative Annex ZA, which is an integral part of this d

27、ocument. 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

28、, 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 9170-2:2008 has been approved by CEN as a EN ISO 9170-2:2008 without any modification. This documen

29、t (EN ISO 9170-2:2008) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and Introduction Anaesthetic gas scavenging system (AGSS) terminal units are the points in an anaesthetic gas scavengin

30、g system where the operator makes connections and disconnections for the disposal of medical gases and anaesthetic vapours from anaesthetic machines or other items of medical equipment, and where a wrong connection may create a hazard to the patient. It is important that terminal units and their com

31、ponents 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; type specificity; dimensions of probes and type-specific connection points; cl

32、eanliness; testing; identification; information supplied. This part of ISO 9170 specifies the provision of information for the installation and subsequent testing of terminal units. Testing of terminal units prior to use is critical to patient safety and it is essential that terminal units are not u

33、sed until full testing in accordance with ISO 7396-2 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

34、to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this part of ISO 9170. 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 wi

35、ll expedite any subsequent revisions. 4 DIN EN ISO 9170-2:2009-09 EN ISO 9170-2:2008 (E) 1 Scope 1.1 This part of ISO 9170 specifies the requirements and dimensions for terminal units intended for use in anaesthetic gas scavenging disposal systems in accordance with ISO 7396-2. 1.2 This part of ISO

36、9170 specifies two types of terminal unit according to whether the power device is upstream or downstream of the terminal unit. 1.3 This part of ISO 9170 also specifies requirements and dimensions for the mating counterpart (probe) of the type-specific connection point which is part of the terminal

37、unit. 1.4 This part of ISO 9170 does not specify the ranges of nominal operating pressure for terminal units, which are defined in ISO 7396-2. 1.5 This part of ISO 9170 does not specify requirements for terminal units for use with compressed medical gases and vacuum, which are covered in ISO 9170-1.

38、 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 6506-1:2005, Metall

39、ic materials Brinell hardness test Part 1: Test method ISO 7396-2:2007, Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems ISO 8835-3:2007, Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems ISO 14971:200

40、7, Medical devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen 5 EN ISO 9170-2:2008 (E) DIN EN ISO 9170-2:2009-09 Key 1 type-specific connection 2 hose insert (permanent) 3 point for brazed connection (permanent) 4

41、 terminal unit base block 5 type-specific interface 6 terminal unit check valve (Type 1 only) 7 type-specific connection point 8 socket 9 type-specific probe Figure 1 Diagram of a typical AGSS terminal unit 6 DIN EN ISO 9170-2:2009-09 EN ISO 9170-2:2008 (E) 3 Terms and definitions For the purposes o

42、f this document, the following terms and definitions apply. NOTE A diagram of a typical AGSS terminal unit with an example of terminology is given in Figure 1. 3.1 AGSS Type 1 terminal unit connection point between the receiving system and disposal system at which the operator makes connections and

43、disconnections See Figure 2. 3.2 AGSS Type 1L terminal unit terminal unit to be used in low-flow disposal systems 3.3 AGSS Type 1H terminal unit terminal unit to be used in high-flow disposal systems 3.4 AGSS Type 2 terminal unit connection point between the power device or disposal hose and the rem

44、ainder of the disposal system at which the operator makes connections and disconnections See Figure 2. 3.5 AGSS type-specific having characteristics which prevent interchangeability and thereby allow assignment to one AGSS type only 3.6 AGSS type-specific connection point that part of the AGSS socke

45、t which is the receptor for an AGSS type-specific probe 3.7 anaesthetic gas scavenging system AGSS complete system that 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 to an appropriate place of dischar

46、ge NOTE Functionally, an AGSS comprises three different parts: a transfer system, a receiving system and a disposal system. These three functionally discrete parts may be either separate or sequentially combined in part or in total. In addition, one or more parts of an AGSS can be combined with a br

47、eathing system or other equipment to include the transfer system or transfer and receiving systems. See Figure 2. 3.8 terminal unit check valve valve that remains closed until opened by insertion of an appropriate probe and which then flows in either direction 3.9 disposal hose that part of the AGSS

48、 which transfers expired and/or excess anaesthetic gases from the power device to the probe of the AGSS Type 2 terminal unit 7 EN ISO 9170-2:2008 (E) DIN EN ISO 9170-2:2009-09 8 DIN EN ISO 9170-2:2009-09 EN ISO 9170-2:2008 (E) Key 1 apparatus including breathing system, integral transfer/receiving s

49、ystem and power device 2 apparatus including breathing system 3 transfer/receiving system and power device 4 apparatus including breathing system and integral transfer/receiving system 5 permanent or proprietary connector 6 receiving hose 7 breathing system or anaesthetic ventilator 8 transfer tube 9 receiving system 10 power device 11 permanent connection 12 discharge 13 flexible hose or pendant 14 disposal hose 15 limit of breathing system 16 limit of transfer system 17 limit of receiving system 18 limit o