EN ISO 10079-1-2009 718 Medical suction equipment - Part 1 Electrically powered suction equipment - Safety requirements《医用抽吸设备 第1部分 电动抽吸设备 安全要求》.pdf

1、BS EN ISO10079-1:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDMedical suctionequipmentPart 1: Electrically powered suctionequipment Safety requirements (ISO10079-1:1999)Copyright European Committee for Standardization Provided by IHS under li

2、cense with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 April2009 BSI 2009ISBN 978 0 580 65197 7Amendments/corrigenda issued since publicationDate Comment

3、sBS EN ISO 10079-1:2009National forewordThis British Standard is the UK implementation of EN ISO10079-1:2009. It is identical to ISO 10079-1:1999. It supersedes BS ENISO 10079-1:2000 and which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/1, Breathin

4、g attachments and anaesthetic machines.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British

5、Standard cannot confer immunityfrom legal obligations.Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10079-1March 2009ICS 1

6、1.040.10 Supersedes EN ISO 10079-1:1999 English VersionMedical suction equipment - Part 1: Electrically powered suctionequipment - Safety requirements (ISO 10079-1:1999)Appareils daspiration mdicale - Partie 1: Appareilslectriques daspiration - Prescriptions de scurit (ISO10079-1:1999)Medizinische A

7、bsauggerte - Teil 1: Elektrisch betriebeneAbsauggerte - Sicherheitsanforderungen (ISO 10079-1:1999)This European Standard was approved by CEN on 24 February 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard

8、the status of a national standard without any alteration. 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, Germ

9、an). A version in any other language made by translationunder 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 Repu

10、blic, 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 COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NOR

11、MALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10079-1:2009: ECopyright European Committee for Standardization Provided by IHS und

12、er license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10079-1:2009EN ISO 10079-1:2009 (E) 3 Foreword The text of ISO 10079-1:1999 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International

13、 Organization for Standardization (ISO) and has been taken over as EN ISO 10079-1:2009 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 publication of

14、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 shall not

15、be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10079-1:1999. 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. For

16、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, Cyprus,

17、 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 10079

18、-1:1999 has been approved by CEN as a EN ISO 10079-1:2009 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10079-1:2009EN ISO 10079-1:2009 (E)

19、4 Annex ZA (informative) Relationship between this European Standard and 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 E

20、ssential Requirements of the New Approach Directive 93/42/EEC on medical 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 sta

21、ndard given in Table ZA.1 confers, within the limits of the scope of this 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-

22、clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes All 1, 2, 3, 4, 6 - 1 (2ndparagraph, 1stdash) This relevant Essential Requirement is not addressed in this European Standard - 1 (2ndparagraph, 2nddash) This relevant Essential Requirement is not addres

23、sed in this European Standard - 6aThis relevant Essential Requirement is not addressed in this European Standard 6 9.1, 13 6 7.5 (2ndparagraph) This relevant Essential Requirement is not fully addressed in this European Standard - 12.1a) This relevant EssentialRequirement is not addressed in this Eu

24、ropean Standard. 6.1 e) 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 6.1 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 6 (6.1 p), 6.3 c) 12.9 6.8.2 7.5 (3rdparagraph) This relevant Essential Requirement

25、 is not fully addressed in this European Standard Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10079-1:2009EN ISO 10079-1:2009 (E) 5 Table ZA.1 - Correspondence betw

26、een this European Standard and EU Directives (continued) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.8.2 13.6 (h)(2ndparagraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.8.2 13.6 (q) Th

27、is relevant Essential Requirement is not addressed in this European Standard: covered by EN ISO 13485: 2003, subclause 4.2.3 9 12.6 10 12.710.1 9.2, 12.7.1 10.2 9.2, 12.7.1 10.3 9.2, 12.7.110.4 9.2, 12.7.1 10.5 9.2, 12.7.1 10.6 12.7.2, 12.7.311 11 11.8 12.5 12 7.1, 9.313.1 12.7.5 13.2 7.1, 9.3 13.3

28、7.2, 7.5, 9.1 13.3 (44.2) 8.1 13.3 (44.3) 7.6 13.3 (44.4) 7.6 13.3 (44.6) 7.6 13.3 (44.7) 1 8.1 13.4 9.2, 12.7.1Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10079-1:

29、2009EN ISO 10079-1:2009 (E) 6 Table ZA.1 - Correspondence between this European Standard and EU Directives (continued) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 13.5 9.2, 12.8 13.8 (49.2) 8.1 14.2 12.8.215 1 (1stparagraph), 2, 4 1

30、5 (53.2, 53.3) 5 15.1 4 15.2 9.2 16 1, 2, 3 16.1 7.316.3 9.1, 9.2 16.3 (56.5) 12.8.2 16.3 (56.8) 10.1, 10.2, 10.3, 12.8.2, 12.9 16.3 (56.11) 12.7.1 16.3 (56.12) 9.1, 12.7.4 16.4 9.1, 12.7.4, 12.6, 12.8.1 16.5 12.7.416.6 2, 3, 12.8.1, 12.9 16.6 (59.11) 10.1, 10.2, 10.3, 12.9 16.6 (59.11.2) 9.2, 9.3 1

31、6.6 (59.12) 7.2 59 7.5 (1stparagraph) This relevant Essential Requirement is not fully addressed in this European Standard Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN I

32、SO 10079-1:2009EN ISO 10079-1:2009 (E) 7 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential requirements of Directive 2006/42/EC on M

33、achinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of conformity for

34、the machinery directive. Table ZA.2 Relevant Essential Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC) Clause(s)/sub-clause(s) of this EN Essential Health and SafetyRequirements (EHSRs) of Direct

35、ive 2006/42/EC Qualifying remarks/Notes- 1.1.4 This relevant EHSR is not addressed in this European Standard - 1.2.2 This relevant EHSR is not addressed in this European standard; only partially covered by EN 60601-1-6 and EN 14971 - 1.5.4 This relevant EHSR is not fully addressed in this European S

36、tandard: only partially covered in EN 14971 and EN 62366 - 1.6.1 This relevant EHSR is not addressed in this European Standard - 1.6.2 This relevant EHSR is not addressed in this European Standard - 1.6.3 This relevant EHSR is not addressed in this European Standard - 3.4.5 This relevant EHSR is not

37、 addressed in this European Standard - 3.6.2 This relevant EHSR is not addressed in this European Standard WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Copyright European Committee for Standardization Provided by IH

38、S under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10079-1:2009 ISOISO 10079-1:1999(E)iiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The w

39、ork of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governme

40、ntal, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.Draft Int

41、ernational Standards adopted by the 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.International Standard ISO 10079-1 was prepared by Technical Committee ISO/TC 121, A

42、naesthetic andrespiratory equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use.This second edition cancels and replaces the first edition (ISO 10079-1:1991), which has been technically revised.ISO 10079 consists of the following parts, under the general title Medical suc

43、tion equipment:Part 1: Electrically powered suction equipment Safety requirementsPart 2: Manually powered suction equipmentPart 3: Suction equipment powered from vacuum or pressure sourceAnnexes A to L of this part of ISO 10079 refer to Appendixes A to L of IEC 60601:1988, respectively. Annexes M, N

44、and O are for information only.Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10079-1:2009Copyright European Committee for Standardization Provided by IHS under licens

45、e with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 10079-1:2009INTERNATIONAL STANDARD ISO ISO 10079-1:1999(E)1Medical suction equipment Part 1:Electrically powered suction equipment Safety requirements1 ScopeThis part of ISO 10079 specifies minimum

46、 safety and performance requirements for medical and surgical suctionequipment (see Figure 1) for health care facilities such as hospitals, for domiciliary care of patients and for field andtransport use.Although such equipment may be driven by centrally powered piped vacuum systems, compressed gase

47、s andelectricity, or be manually powered for a variety of applications, this part of ISO 10079 addresses only mainselectricity- and battery-powered suction equipment.NOTE See also annex M in this part of ISO 10079.ISO 10079-1 is one of a series of International Standards based on IEC 60601-1:1988; i

48、n IEC 60601-1 (the“General Standard“), this type of International Standard is referred to as a “Particular Standard“. As stated in 1.3 ofIEC 60601-1:1988, the requirements of this part of ISO 10079 take precedence over those of IEC 60601-1.The scope and object given in clause 1 of IEC 60601-1:1988 apply, except that 1.1 shall be replaced by thefollowing:This part of ISO 10079 is not applicable to:a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings,and wall connectors;b) catheter tubes, drains, curettes and suction t