EN ISO 81060-1-2012 en Non-invasive sphygmomanometers - Part 1 Requirements and test methods for non-automated measurement type《非侵入式血压计 第1部分 非自动测量型试验方法和要求》.pdf

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1、BRITISH STANDARDBS ISO 81060-1:2007Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measurement typeICS 11.040.10 BS EN ISO 81060-1:2012BS ISO 81060-1:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 3

2、1 December 2007 BSI 2007ISBN 978 0580 55650 0National forewordThis British Standard is the UK implementation of ISO 81060-1:2007.The UK participation in its preparation was entrusted byTechnical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/5, Lungventilators, trach

3、eal tubes and related equipment.A list of organizations represented on this committee can be obtained on request 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 Standa

4、rd cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date CommentsBS ISO 81060-1:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2007 BSI 2007ISBN 978 0580 55650 0National forewordThis B

5、ritish Standard is the UK implementation of ISO 81060-1:2007.The UK participation in its preparation was entrusted byTechnical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/5, Lungventilators, tracheal tubes and related equipment.A list of organizations represented

6、on this committee can be obtained on request 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 Standard cannot confer immunity from legal obligations.Amendments issued s

7、ince publicationAmd. No. Date CommentsBS EN ISO 81060-1:2012ISBN 978 0 580 76363 2Amendments/corrigenda issued since publicationDate Comments31 July 2012 The corrigendum renumbers BS ISO 81060-1:2007 as BS EN ISO 81060-1:2012This British Standard was published under the authority of the Standards Po

8、licy and Strategy Committee on 31 December 2007 The British Standards Institution 2012 Published by BSI Standards Limited 2012This British Standard is the UK implementation of EN ISO 81060-1:2012. It is identical to ISO 81060-1:2007. It supersedes BS ISO 81060-1:2007, BS EN 1060-1:1995+A2:2009 and B

9、S EN 1060-2:1995+A1:2009, which are withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/10, Sphygmomanometers.A list of organizations represented on this subcommittee can be obtained on request to its secre

10、tary.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 81060-1 May 2012 ICS 11.040.10 Supersedes EN 1060-1:1995+A2:2009, EN 1060-2:1995+A1:2009English Version Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) Sphygmoma

11、nomtres non invasifs - Partie 1: Exigences et mthodes dessai pour type mesurage non automatique (ISO 81060-1:2007) Nicht invasive Blutdruckmessgerte - Teil 1: Anforderungen und Prfverfahren der nicht-automatisierten Bauart (ISO 81060-1:2007) This European Standard was approved by CEN on 28 April 201

12、2. CEN members are bound to comply with the CEN/CENELEC Internal Regulations 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 o

13、n application to the CEN-CENELEC 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENE

14、LEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta

15、, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights o

16、f exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 81060-1:2012: EEN ISO 81060-1:2012 (E) 3 Foreword The text of ISO 81060-1:2007 has been jointly prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the Internati

17、onal Organization for Standardization (ISO) and Sub-Committee IEC/SC 62D “Electromedical equipment” of the International Electrotechnical Commission (IEC) and has been taken over as EN ISO 81060-1:2012 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by

18、 DIN. 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 November 2012, and conflicting national standards shall be withdrawn at the latest by May 2015. Attention is drawn to the possibility that som

19、e 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 1060-1:1995+A2:2009, EN 1060-2:1995+A1:2009. This document has been prepared under a mandate given to CE

20、N by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. EN ISO 81060 consists of the following parts, under the general t

21、itle Non-invasive sphygmomanometers: Part 1: Requirements and test methods for non-automated measurement type Part 2: Clinical validation of automated measurement type According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to impl

22、ement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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, Sw

23、itzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 81060-1:2007 has been approved by CEN as a EN ISO 81060-1:2012 without any modification. BS EN ISO 81060-1:2012EN ISO 81060-1:2012EN ISO 81060-1:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard

24、and the Essential Requirements of EU Directive 93/42/EEC on medical devices 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 Directiv

25、e 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union 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

26、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 Directive 93/42/EEC on medical devices (1/3) Clause(s)/sub-clause(s) of this EN Essent

27、ial Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.4.3, 8.3, 8.4, 8.5 7.2 Prevention of risks related to mercury leakage and spillage only. Packaging is not addressed. Design and manufacture are addressed via tests on finished products. 8.3, 8.4, 8.5 7.5 (first sentence) Only p

28、revention of risks due to mercury leakage 10.1, 10.2 8.1 Only reduction of the risk of infection to a commonly accepted level is addressed (not “as far as possible”). Manufacturing processes are not addressed. Easy handling is not addressed. 10.3 8.4 4.7 b) 8.7 ER 8.7 is partially addressed. 6.2, 7.

29、1.2, 7.2.4, 7.2.5, 7.2.6, 12.2.1 c) 9.1 6.3, 7.2.3 9.2 (1stindent) Prevention of injury due to rough surfaces and prevention of injury due to excessive pressure are addressed. 6.2, 6.3, 6.4 9.2 ER 9.2 is partially addressed. 6.2 9.3 Only addressed for electrical devices via IEC 60601-1, Clauses 11 a

30、nd 13. 4.4 e), 6.2, 7.1.1, 7.1.2, 7.2.1, 7.2.2, 7.4, 8.1, 9, 12.2.1 b), 12.2.1 l), 12.2.1 n), 12.2.1 q), 12.3.b), 12.3.c) 10.1 For electrical devices, see also IEC 60601-1 Clause 12, as required in Clause 6.2 of the present standard. BS EN ISO 81060-1:2012EN ISO 81060-1:2012EN ISO 81060-1:2012 (E) 5

31、 Table ZA.1 (2/3) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.2, 4.3, 4.4 e), 4.5, 6.2, 10.2 For electrical devices, see also IEC 60601-1 Clauses 7 and 12, as required in Clause 6.2 of the present standard. 4.1, 6.2 10.3 For elect

32、rical devices, see also IEC 60601-1 subclause 7.4.3, as required in Clause 6.2 of the present standard. 6.2 12.1 Only addressed for electrical devices via IEC 60601-1, Clause 14. 6.2 12.1 a) Only addressed for electrical devices via IEC 60601-1, Clause 14. 6.2 12.5 Only addressed for electrical devi

33、ces via IEC 60601-1, Clause 17. 6.2 12.6 Only addressed for electrical devices via IEC 60601-1, Clause 8. 6.2, 6.3 12.7.1 For electrical devices, see also IEC 60601-1 Clauses 9 and 15, as required in Clause 6.2 of the present standard. 6.2 12.7.2 Only addressed for electrical devices via IEC 60601-1

34、, Clause 9. 6.2 12.7.3 Only addressed for electrical devices via IEC 60601-1, Clause 9. 6.2 12.7.4 Only addressed for electrical devices via IEC 60601-1, Clauses 8 and 15. 6.2 12.7.5 Only addressed for electrical devices via IEC 60601-1, Clause 11. 12.2.1 f), 12.2.1 h) 12.9 4, 6.2, 12 13.1 4.4, 4.7,

35、 12.2.1 h) 13.2 4.4 a), 6.2, 12.1 13.3 a) The part of ER 13.3.a) relating to the authorized representative is not addressed. 4.4 b), 4.7 a) 13.3 b) 4.7 b) 13.3 c) BS EN ISO 81060-1:2012EN ISO 81060-1:2012EN ISO 81060-1:2012 (E) 6 Table ZA.1 (3/3) Clause(s)/sub-clause(s) of this EN Essential Requirem

36、ents (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.4 c) 13.3 d) The presumption of conformity is only provided if the batch number is preceded by the word “LOT”. 4.7 c) 13.3 e) 4.7 d) 13.3 f) The presumption of conformity is only provided if the indication of single use is consistent acros

37、s the Community. 4.7 e) 13.3 i) 4.6 a), 4.6 b) 13.3 j) 12.2.1 m), 12.2.1 n) 13.3 k) 6.2 13.3 l) 4.7 b) 13.3 m) 4.6 b), 4.7 f), 12.2.1 a) 13.4 4.4 b), 4.4 c), 6.2 13.5 12.1, 12.2.1 g), 12.2.1 p), 12.2.1 r), 12.2.1 s) 13.6 a) This Essential Requirement is partially addressed. 12.2.1.e), 12.2.1 k), 12.

38、2.1 l), 12.2.4 13.6 c) 12.2.1 e), 12.2.1 j), 12.2.1 k), 12.2.1 o), 12.2.1 s), 12.2.3 13.6 d) 6.2 13.6 f) ER 13.6 f) is addressed only for electrical devices via IEC 60601-1. 12.2.2 13.6 h) The part of ER 13.6 h) relating to “single use” is not addressed. 12.2.1 c), k) 13.6 i) For electrical devices,

39、 see also IEC 60601-1 Clause 7, as required in Clause 6.2 of the present standard. 4.4 d), 6.2, 12.2.1 t), 12.2.5 13.6 n) BS EN ISO 81060-1:2012EN ISO 81060-1:2012EN ISO 81060-1:2012 (E) 7 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, i

40、n 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 corresponding clauses of this European Standard.

41、 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. NOTE Table ZA.2 is only applicable to electrical devices. Table ZA.2 Relevant Essential Health and Safety Requirements from Dir

42、ective 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 Safety Requirements (EHSRs) of Directive 2006/42/EC Qualifying remarks/Notes4.5, 6.2 1.2.2 Only partly addressed

43、 6.2 1.5.17.2.6, 7.3 1.5.4 Errors of fitting are only reduced to a commonly accepted level, but are not made “impossible” 6.2 1.5.56. 1.5.6 6.2 1.5.76. 1.6.3Only partly addressed WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this s

44、tandard. BS EN ISO 81060-1:2012EN ISO 81060-1:2012iiiContents PageForeword. vIntroduction. vi1* Scope. 12Normative references. 13Terms and definitions. 24Identification and marking. 54.1 * Units of measurement 54.2 * Legibility of markings 54.3 * Durability of markings54.4 * Marking of non-automated

45、 sphygmomanometer 54.5 * Usability of reading 64.6 Marking of the cuff 64.7 Marking of the non-automated sphygmomanometer packaging. 65General requirements for testing non-automated sphygmomanometers 75.1 * Type tests 75.2 * Representativesample 75.3 Environmental conditions 75.4 Repairs and modific

46、ations. 75.5 * Humidity preconditioning treatment 76General requirements. 86.1 General. 86.2 Electrical safety. 86.3 Mechanical safety. 86.4 Mechanical strength. 87Requirements107.1 Pressure indicating means 107.2Pneumatic system 117.3 * Tamper proofing or unauthorized access .147.4 Dynamic response

47、 in normal use . 148Additional requirements for non-automated sphygmomanometer with mercurymanometer. 158.1* Internal diameter of the tube containing mercury 158.2* Portable non-automated sphygmomanometer. 158.3 * Prevention of mercuryspillage during transport 158.4* Prevention of mercuryspillage in

48、 normal use 158.5 Quality of the mercury 169Non-automated sphygmomanometers with aneroid manometer 169.1* Scale mark at zero 169.2* Zero 169.3Hysteresis error 169.4* Construction and materials. 1710 Cleaning, sterilization and disinfection 1710.1 Reusable non-automated sphygmomanometer and parts. 17

49、10.2 Non-automated sphygmomanometer and parts requiring processing before use.1710.3 Non-automated sphygmomanometer and parts delivered sterile.1811 Biocompatibility 18BS ISO 81060-1:2007BS EN ISO 81060-1:2012EN ISO 81060-1:2012iv 12 Information supplied by the manufacturer.1812.1Accompanying document1812.2 Instructions for use.1812.3 Technical description.21Annex A (informative) Rationale and guidance.23Annex B