EN ISO 11197-2009 en Medical supply units《医疗供应设备》.pdf

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1、BS EN ISO11197:2009ICS 11.040.10,NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDMedical supply units(ISO 11197:2004)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 May 2009 BSI 2009ISBN 978 0 580 65570 8A

2、mendments/corrigenda issued since publicationDate CommentsBS EN ISO 11197:2009National forewordThis British Standard is the UK implementation of EN ISO 11197:2009.It is identical to ISO 11197:2004. It supersedes BS EN ISO 11197:2004which is withdrawn.The UK participation in its preparation was entru

3、sted to TechnicalCommittee CH/121/6, Medical gas supply systems.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.C

4、ompliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11197April 2009ICS 11.040.10 Supersedes EN ISO 11197:2004 English VersionMedical supply units (ISO 11197:2004)Gaines techniques usage mdical (ISO 11197:2004) Medizinis

5、che Versorgungseinheiten (ISO 11197:2004)This European Standard was approved by CEN on 21 March 2009.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-

6、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, German). A version in any other language made by translationunder

7、 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 Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hung

8、ary, 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 NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Av

9、enue 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 11197:2009: EBS EN ISO 11197:2009EN ISO 11197:2009 (E) 3 Foreword The text of ISO 11197:2004 has been prepared by Technical Committee ISO/TC 121

10、 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11197:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given t

11、he status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 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 th

12、e 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 ISO 11197:2004. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and

13、 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 national standards organizations of the following countries are bound to implement this E

14、uropean 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, Slovakia, Slovenia, Spain, Sweden, Switzerland and the Uni

15、ted Kingdom. Endorsement notice The text of ISO 11197:2004 has been approved by CEN as a EN ISO 11197:2009 without any modification. BS EN ISO 11197:2009EN ISO 11197:2009 (E) 4 Annex ZA (Informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC

16、 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 devices. Once this standard is cited in the Official

17、 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 this standard, a presumption of conformity with the corr

18、esponding 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 Qualifying remarks/Notes All 1 (1st paragraph), 1 (2nd

19、 paragraph 1st dash), 1 (2nd paragraph 2nd dash) All 2 All 3 4 6,9.3 6.1a) 13.3a) 6.1g) 13.3a), 13.3b)6.1k) 13.2, 13.3a), 13.3b) 6.1l) 13.3b) 6.1y) 13.2, 13.3b)6.1aa) 13.2, 13.3b) 6.2 7.6, 9.1 6.8 7.1, 13.1, 13.4, 13.6a), b), c), d) 6.8.2 13.1, 13.6a), b), c), d) 6.8.2a) 13.4 6.8.3 13.1Section 3 12.

20、6 Section 4 12.7.1 21.101 4, 9.221.101.2 9.221.101.3 9.2 26.101 12.7.2, 12.7.336.101 12.542 12.7.5 BS EN ISO 11197:2009EN ISO 11197:2009 (E) 5 42.101 12.7.5 43 7.1, 9.343.2 7.1, 9.356.1 9.2, 12.6 57.1 9.2, 12.657.2 9.2, 12.657.6 9.2, 12.6 58.101 9.2, 12.659.101.1 12.7.459.101.1a) 7.1, 7.3 59.101.2 7

21、.3, 12.7.459.101.2a) 7.359.101.2c) 7.5 59.102.2c) 7.559.103.1a) 7.1, 7.359.103.1b) 7.1, 7.3 59.103.1c) 7.1, 7.359.103.2b) 7.559.104.1 9.1, 12.7.4 59.104.2 9.1, 12.7.459.104.3a) 9.159.104.3e) 7.1, 7.3 59.104.3g) 9.1- 13.6q) This relevant Essential Requirement is not addressed in this European Standar

22、d : covered by EN ISO 13485: 2003, 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. BS EN ISO 11197:2009EN ISO 11197:2009 (E) 6 For devices which are also machinery within the meaning of Article 2(a) of

23、 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 Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the correspondi

24、ng 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 the machinery directive. Table ZA.2 Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on

25、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) ofDirective 2006/42/EC Qualifying remarks/Notes - 1.1.4 This relevant Essential Requirement is not address

26、ed in this European Standard. To be addressed by EN14971 and in some cases portions of EN 60601-1;3rd ed. - 1.2.2 This relevant EHSR is not specifically addressed in this European standard; only partially covered by EN 60601-1-6 and EN 14971 - 1.5.4 This relevant EHSR is not specifically addressed i

27、n this European standard; only partially covered in EN 14971 and EN 62366 - 1.6.1 This relevant EHSR is only partly addressed in subclause 6.8.2 of this European standard; see EN 60601-1 and EN 14971 - 1.6.2 This relevant EHSR is not addressed in this European standard; see EN 60601-1 and EN 14971 -

28、 1.6.3 This relevant Essential Requirement is not addressed in this European Standard. - 3.4.5 This relevant EHSR is not specifically addressed in this European standard: it is partially covered in EN 60601-1 and EN 14971 - 3.6.2 This relevant Essential Requirement is not addressed in this European

29、Standard BS EN ISO 11197:2009ISO 11197:2004(E) ISO 2004 All rights reserved iiiForeword ISO (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 I

30、SO technical committees. Each member body interested in a subject for which a technical committee 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

31、closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards.

32、Draft International 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. Attention is drawn to the possibility that some of the elements of this d

33、ocument may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11197 was prepared by the European Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcom

34、mittee SC 6, Medical gas systems, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout the text of this document, read “.this European Standard.” to mean “.this International Standard.”. This second edition cancels and replaces the first editio

35、n (ISO 11197:1996), which has been technically revised. Annex ZB provides a list of corresponding International and European Standards for which equivalents are not given in the text. For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council Directives h

36、as been removed. BS EN ISO 11197:2009ISO 11197:2004(E) iv ISO 2004 All rights reservedContents page Forewordvii Introductionviii SECTION ONE - GENERAL 1 1 Scope 1 2 Normative references 1 3 Terms and definitions .2 4 General requirements and requirements for tests.2 5 Classification3 6 Identificatio

37、n, marking and documents.3 7 Power input 7 SECTION TWO - ENVIRONMENTAL CONDITIONS8 8 Basic safety categories.89 Removable protection means.810 Environmental conditions.8 11 Not Used .8 12 Not Used .8 SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS.9 13 General9 14 Requirements related to c

38、lassification9 15 Limitation of voltage and/or energy.916 Enclosures and protective covers .917 Separation 918 Protective earthing, functional earthing and potential equalization 919 Continuous leakage current and patient auxiliary currents920 Dielectric strength .10 SECTION FOUR - PROTECTION AGAINS

39、T MECHANICAL HAZARDS 11 21 Mechanical strength 11 22 Moving parts.11 23 Surfaces, corners and edges11 24 Stability in normal use 11 25 Expelled parts 12 26 Vibration and noise12 27 Pneumatic and hydraulic power.12 28 Suspended masses .12 BS EN ISO 11197:2009ISO 11197:2004(E) ISO 2004 All rights rese

40、rved vSECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION.13 29 X-Radiation.13 30 Alpha, beta, gamma, neutron radiation and other particle radiation .13 31 Microwave radiation 13 32 Light radiation (including lasers).13 33 Infra-red radiation13 34 Ultraviolet radiation.13

41、35 Acoustical energy (including ultrasonics)13 36 Electromagnetic compatibility .13 SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES 15 37 Locations and basic requirements 15 38 Marking and accompanying documents.15 39 Common requirements for Category AP and Cat

42、egory APG Equipment15 40 Requirements and tests for Category AP Equipment, parts and components thereof .15 41 Requirements and tests for Category APG Equipment, parts and components thereof.15 SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS .16 42 Excessive temper

43、atures16 43 R Fire prevention .16 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection.16 45 Pressure vessels and parts subject to pressure16 46 Human errors .17 47 Electrostatic charges 17 48 Material in applied parts in contact with the body of the

44、 patient .17 49 Interruption of the power supply .17 SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT18 50 Accuracy of operating data 18 51 Protection against hazardous output18 SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS, ENVIRONMENTAL TESTS1952 Abnormal

45、 operation and fault conditions .19 53 Environmental tests 19 SECTION TEN - CONSTRUCTIONAL REQUIREMENTS 1954 General1955 Enclosures and covers .19 56 Components and general assembly19 57 Mains parts, components and layout 19 58 Protective earthing - terminals and connections.20 59 Construction and l

46、ayout .21 Annexes.33 BS EN ISO 11197:2009ISO 11197:2004(E) vi ISO 2004 All rights reservedAnnex A A (normative) Special National Conditions 34 Annex B B (informative) Rationale35 Annex ZB (Informative) Normative references to international publications with their relevant European publications 37 Bi

47、bliography38 BS EN ISO 11197:2009ISO 11197:2004(E) ISO 2004 All rights reserved viiForeword This document (EN ISO 11197:2004) has been prepared by CEN /TC 215, “Respiratory and anaesthetic equipment“, the secretariat of which is held by BSI, in collaboration with ISO/TC121/SC6 “Medical gas systems“.

48、 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 June 2005, and conflicting national standards shall be withdrawn at the latest by June 2005. This document supersedes EN 793: 1997. This European S

49、tandard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports essential requirements of EU Directive(s). For special national conditions for Clauses 6.1 k), 6.1 bb), 6.2 aa) and 57.1, see Annex AA. For a list of International Standards identical to the European Standards referred to in this European Standard, see informative Annex ZB. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europea