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1、BS EN ISO 10079-2:2009 ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Medical suction equipment Part 2: Manually powered suction equipment (ISO 10079-2:1999) Licensed CopyChinese University of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c)
2、BSI This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2009 BSI 2009 ISBN 978 0 580 65195 3 Amendments/corrigenda issued since publication DateComments BS EN ISO 10079-2:2009 National foreword This British Standard is the UK implementat
3、ion of EN ISO 10079-2:2009. It is identical to ISO 10079-2:1999. It supersedes BS EN ISO 10079-2:2000 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/121/1, Breathing attachments and anaesthetic machines. A list of organizations represented on this
4、 committee 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. Licensed CopyChinese U
5、niversity of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10079-2 March 2009 ICS 11.040.10Supersedes EN ISO 10079-2:1999 English Version Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999) Appar
6、eils daspiration mdicale - Partie 2: Appareils daspiration manuelle (ISO 10079-2:1999) Medizinische Absauggerte - Teil 2: Handbetriebene Absauggerte (ISO 10079-2:1999) This European Standard was approved by CEN on 24 February 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regula
7、tions which stipulate the conditions 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 E
8、uropean Standard exists in three official 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
9、 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland
10、 and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO
11、10079-2:2009: E Licensed CopyChinese University of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:2009 EN ISO 10079-2:2009 (E) 3 Foreword The text of ISO 10079-2:1999 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the Interna
12、tional Organization for Standardization (ISO) and has been taken over as EN ISO 10079-2:2009 by Technical Committee CEN/TC 215 “Respiratory 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 publicati
13、on of an identical text or by endorsement, at the latest by September 2009, and conflicting national standards shall be withdrawn at the latest by March 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 shal
14、l not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10079-2:1999. 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 Directives
15、. For relationship with EC Directives, 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 Standard: Austria, Belgium, Bulgaria, C
16、yprus, 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 the United Kingdom. Endorsement notice The text of ISO
17、 10079-2:1999 has been approved by CEN as a EN ISO 10079-2:2009 without any modification. Licensed CopyChinese University of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:2009 EN ISO 10079-2:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and
18、 the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical
19、 devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of thi
20、s standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 - Correspondence between this European Standard and EU Directives Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC
21、 Qualifying remarks/Notes All 1, 2, 6 4.1, 4.2, 4.3, 4.4 4, 8.1 5 1, 2, 3 5.1, 5.2 9.1 5.2.2 9.2 6 1, 2, 3, 9.2 6.1 9.2 Licensed CopyChinese University of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:2009 EN ISO 10079-2:2009 (E) 5 Clause(s)/sub-clause(s) of this EN Essen
22、tial Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.2 4, 8.1, 9.2 6.3 4, 7.6, 9.2, 12.7.1 6.4 4, 7.6 6.5 4, 7.2, 7.5, 9.2, 12.7.1 6.6 7.2, 8.1, 12.8.2 6a This relevant Essential Requirement is not addressed in this European Standard 6.6 7.5 (1st paragraph) This relevant Essenti
23、al Requirement is not fully addressed in this European Standard - 7.5 (2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard - 7.5 (3rd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.6.1, 6.6.2 7.5 6.7 1
24、0.1, 10.2, 10.3, 12.8.2, 12.9 6.7.1, 6.7.2, 6.7.3 10.2 7.1, 7.2, 7.3 9.2 Licensed CopyChinese University of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:2009 EN ISO 10079-2:2009 (E) 6 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC
25、Qualifying remarks/Notes 7.3.3 10.1, 10.2, 10.3 7.3.4 9.2, 12.8.2 8.1, 8.2, 8.3 12.8.1 9.1 4, 9.2 9.2 4, 5 10 d), 10 e), 11 a) b) e) i) o) 9.1 10 a) d) e) 12.9 10, 11 13 10 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 11 13.3 (f) This relevant Essent
26、ial Requirement is not fully addressed in this European Standard 11 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 11 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard: covered by EN ISO 13485: 2003,
27、subclause 4.2.3 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Licensed CopyChinese University of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:2009 ISOISO 10079-2:1999(E) iii Foreword ISO
28、(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 interested in a subject for which a technical comm
29、ittee 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 Electrotechnical Commission (IEC) on all matters of electrote
30、chnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires appro
31、val by at least 75 % of the member bodies casting a vote. International Standard ISO 10079-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use. This second edition cancels and replaces the fir
32、st edition (ISO 10079-2:1992), which has been technically revised. ISO 10079 consists of the following parts, under the general title Medical suction equipment: Part 1: Electrically powered suction equipment Safety requirements Part 2: Manually powered suction equipment Part 3: Suction equipment pow
33、ered from vacuum or pressure source Annex A forms a normative part of this part of ISO 10079. Annexes B and C are for information only. Licensed CopyChinese University of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:2009 Licensed CopyChinese University of Hong Kong, 13/0
34、6/2009 07:55, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:2009 INTERNATIONAL STANDARD ISOISO 10079-2:1999(E) 1 Medical suction equipment Part 2: Manually powered suction equipment 1 Scope This part of ISO 10079 specifies safety and performance requirements for manually powered medical suction equip
35、ment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both (see Figure 1). Non-electrical suction equipment which may be integrated with electrical equipment is included in the scope of this part of ISO 10079. This part of ISO 10079 does not apply to electrical
36、ly powered suction equipment, whether mains electricity- or battery-powered, which is dealt with in ISO 10079-1, nor to suction equipment powered from a vacuum or pressure source which is dealt with in ISO 10079-3, nor to the following: a) central power supply (by vacuum/compressed air generation),
37、piping systems of vehicles and buildings, and wall connectors; b) cathether tubes, drains, curettes and suction tips; c) syringes; d) dental suction equipment; e) waste gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) passive urinary drainage; i) closed systems for wound
38、 drainage; j) gravity gastric drainage; k) orally operated mucous extractors; l) suction equipment where the collection container is downstream of the vacuum pump; m) equipment marked as suction unit for permanent tracheostomy; n) ventouse (obstetric) equipment; o) neonatal mucous extractors; p) bre
39、ast pumps; q) liposuction; r) uterine aspiration; s) thoracic drainage. Licensed CopyChinese University of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:2009 ISO 10079-2:1999(E) ISO 2 Key 1Vacuum indicator 2Filter 3Collection container 4Vacuum regulator NOTE 1ISO 10079-1
40、applies to mains electricity- and battery-powered suction equipment. ISO 10079-2 applies to manually powered suction equipment. ISO 10079-3 applies to suction equipment powered from a vacuum or pressure source. NOTE 2Components illustrated are not necessarily required by this part of ISO 10079. NOTE
41、 3Suction equipment shown is an example only, and actual systems may consist of other arrangements and components which are not illustrated. Figure 1 Examples of suction equipment 2 Normative references The following normative documents contain provisions which, through reference in this text, const
42、itute provisions of this part of ISO 10079. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 10079 are encouraged to investigate the possibility of applying the most recent editions of th
43、e normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 5356-1:1996, Anaesthetic and respiratory equipment Conical connectors Part 1: Con
44、es and sockets. ISO 8836:1997, Suction catheters for use in the respiratory tract. ISO 10079-1:1999, Medical suction equipment Part 1: Electrically powered suction equipment Safety requirements. Licensed CopyChinese University of Hong Kong, 13/06/2009 07:55, Uncontrolled Copy, (c) BSI BS EN ISO 1007
45、9-2:2009 ISOISO 10079-2:1999(E) 3 3 Terms and definitions For the purposes of this part of ISO 10079, the terms and definitions given in ISO 10079-1 and the following apply. 3.1 manually powered vacuum manually generated vacuum generation of vacuum by human effort with a hand or foot or both 3.2 tra
46、nsportable equipment equipment which is intended to be easily moved from one place to another, whether or not connected to the vacuum supply, without an appreciable restriction of range 4 Cleaning and sterilization 4.1 The suction equipment shall meet the requirements given in 8.1 to 8.3 after those
47、 components which are subject to contamination and which are intended for re-use have been submitted to 30 cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer. 4.2 Any filters installed shall either be of the disposable type or be capable of being cleaned, disinf
48、ected and/or sterilized for re-use in accordance with 4.1. 4.3 Suction equipment incorporating a re-usable collection container assembly shall comply with the requirements given in 8.1 to 8.3, as appropriate, before and after the collection container assembly has been subjected to 30 cycles of clean
49、ing, disinfection and/or sterilization as recommended by the manufacturer. 4.4 Suction tubing shall either be for single use or be capable of being cleaned, disinfected and/or sterilized as recommended by the manufacturer. 5 Design requirements NOTE The constructional requirements may deviate from those detailed in this part of ISO 10079 if the equivalent level of safety is obtained. 5.1 Connectors 5.1.1 Collection container connectors The connectors for the suction tubing and the intermediate tubing to the vacu