1、BRITISH STANDARDBS EN ISO 9170-2:2008Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging systemsICS 11.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g
2、55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 9170-2:2008This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 August 2008 BSI 2008ISBN 978 0 580 55058 4National forewordThis British Standard is the UK implementation of EN
3、 ISO 9170-2:2008. It supersedes BS EN 737-4:1998 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/6, Medical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 committee c
4、an 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 issued since pu
5、blicationDate CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 9170-2July 2008ICS 11.040.10 Supersedes EN 737-4:1998 English VersionTerminal units for medical gas pipeline systems - Part 2:Terminal units for anaesthetic gas scavenging systems (ISO9170-2:2008)Prises murales pour systmes
6、de distribution de gazmdicaux - Partie 2: Prises murales pour systmesdvacuation des gaz danesthsie (ISO 9170-2:2008)Entnahmestellen fr Rohrleitungssysteme fr medizinischeGase - Teil 2: Entnahmestellen fr Ansthesiegas-Fortleitungssysteme (ISO 9170-2:2008)This European Standard was approved by CEN on
7、15 May 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 nationalstandards may be obt
8、ained 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 Managem
9、ent 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,
10、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 in any form and by
11、any means reservedworldwide for CEN national Members.Ref. No. EN ISO 9170-2:2008: EForeword This document (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 anaesthetic
12、 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 by July 2010.
13、 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 737-4:1998. This document has been prepared under a manda
14、te 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 document. According to the CEN/CENELEC Internal Regulations, the na
15、tional 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, Netherlands, Norway
16、, 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. BS EN ISO 9170-2:2008iiiContents Page Introduction.v 1 Scope1 2 * Normative re
17、ferences .1 3 Terms and definitions .3 4 General requirements .7 4.1 Safety7 4.2 * Alternative construction.7 4.3 Materials .7 4.4 Design requirements.7 4.5 Construction requirements 14 5 Test methods .14 5.1 General .14 5.2 Endurance test.14 5.3 Test method for pressure drop 15 5.4 Test method for
18、connection force .15 5.5 Test method for disconnection force 15 5.6 Tests for mechanical strength .16 5.7 Tests for leakage .16 5.8 Test for type specificity 16 5.9 Test for effective connection of probes to sockets .16 5.10 Test for connection of receiving or disposal hoses to hose inserts .16 5.11
19、 Test for durability of markings and colour coding 16 6 Marking, colour coding and packaging.16 6.1 Marking.16 6.2 Colour coding 17 6.3 Packaging.17 7 Information to be supplied by the manufacturer .17 Annex A (informative) Rationale18 Annex B (informative) Environmental aspects 19 Annex C (informat
20、ive) Special national and regional conditions for electrical installations21 Bibliography22 BS EN ISO 9170-2:2008Annex ZA (informative) Correspondence between this International Standard and Directive 93/42/EEC 23 blankIntroduction Anaesthetic gas scavenging system (AGSS) terminal units are the poin
21、ts in an anaesthetic gas scavenging 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
22、 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; type specificity; dimensions of probes and t
23、ype-specific connection points; cleanliness; 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 essen
24、tial that terminal units are not used 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 rationa
25、le contained in Annex A, included 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 applicatio
26、n of this part of ISO 9170, but will expedite any subsequent revisions. BS EN ISO 9170-2:2008v blank1Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging systems 1 Scope 1.1 This part of ISO 9170 specifies the requirements and dimensions for terminal
27、units intended for use in anaesthetic gas scavenging disposal systems in accordance with ISO 7396-2. 1.2 This part of ISO 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 requireme
28、nts and dimensions for the mating counterpart (probe) of the type-specific connection point which is part of the terminal 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
29、specify requirements for terminal units for use with compressed medical gases and vacuum, which are covered in ISO 9170-1. 2 * Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For und
30、ated references, the latest edition of the referenced document (including any amendments) applies. ISO 6506-1:2005, Metallic 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, Inhalati
31、onal anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems ISO 14971:2007, Medical devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen BS EN ISO 9170-2:20082 Key 1
32、type-specific connection 2 hose insert (permanent) 3 point for brazed connection (permanent) 4 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
33、 BS EN ISO 9170-2:200833 Terms and definitions For the purposes of 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
34、 and disposal system at which the operator makes connections and 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 conne
35、ction point between the power device or disposal hose and the remainder 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.
36、6 AGSS type-specific connection point that part of the AGSS socket 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 a
37、nd/or excess anaesthetic gases to an appropriate place of discharge 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
38、 addition, one or more parts of an AGSS can be combined with a breathing 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
39、flows in either direction 3.9 disposal hose that part of the AGSS which transfers expired and/or excess anaesthetic gases from the power device to the probe of the AGSS Type 2 terminal unit BS EN ISO 9170-2:20084 BS EN ISO 9170-2:20085Key 1 apparatus including breathing system, integral transfer/rec
40、eiving system 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 transf
41、er 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 of disposal system 19 proprietary connection (functionally specific) 20 30 mm co
42、nical connection 21 type 1 terminal unit probe/socket 22 type 2 terminal unit probe/socket NOTE 1 Type 1 terminal unit probe/socket is for negative pressure. Type 2 terminal unit probe/socket is for positive pressure. NOTE 2 The limit between the receiving system and the disposal system as shown may
43、 not coincide with an actual physical limit such as a wall. Figure 2 Schematic diagram of typical anaesthetic gas scavenging systems 3.10 disposal system means by which expired and/or excess anaesthetic gases are conveyed from the receiving system to an appropriate place of discharge NOTE A place of
44、 discharge can be, for example, the exterior of a building or a non-recirculating extract ventilation system. 3.11 high-flow disposal system disposal system that is intended to operate with a high-flow transfer and receiving system complying with ISO 8835-3 3.12 low-flow disposal system disposal sys
45、tem that is intended to operate with a low-flow transfer and receiving system complying with ISO 8835-3 3.13 maximum test pressure maximum pressure to which the terminal unit is designed to be subjected during pipeline pressure testing BS EN ISO 9170-2:20086 3.14 operating pressure pressure at which
46、 the AGSS terminal unit is designed to operate NOTE The operating pressure for a Type 1 AGSS terminal unit is negative; the operating pressure for a Type 2 AGSS terminal unit is positive. 3.15 power device that part of the AGSS disposal system that provides power for scavenging at specified flows an
47、d pressures 3.16 probe non-interchangeable male component designed for acceptance by, and retention in, a socket 3.17 quick connector pair of non-threaded type-specific components that can be easily and rapidly joined together by a single action of one or both hands without the use of tools 3.18 rec
48、eiving hose that part of an AGSS which transfers expired and/or excess anaesthetic gases from the receiving system to the disposal system 3.19 receiving system that part of an AGSS which provides an interface between a transfer system and a disposal system 3.20 single-fault condition condition in wh
49、ich a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present 3.21 socket that 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 3.22 terminal unit base block that part of a terminal unit which is attached to the disposal system 3.23 terminal unit check valve valve that
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