EN ISO 80601-2-56-2012 en Medical electrical equipment - Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature .pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 80601-2-56:2012Medical electrical equipmentPart 2-56: Particular requirements forbasic safety and essential performance ofclinical thermometers for body temperaturemeas

2、urement (ISO 80601-2-56:2009)BS EN ISO 80601-2-56:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO80601-2-56:2012. It is identical to ISO 80601-2-56:2009. It supersedesBS EN 12470-3:2000+A1:2009, BS EN 12470-4:2000+A1:2009 and BS EN 12470-5:2003 which ar

3、e withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/205, Non-active medical devices.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a co

4、ntract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 77392 1ICS 11.040.55Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the aut

5、hority of theStandards Policy and Strategy Committee on 31 December 2012.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80601-2-56 October 2012 ICS 11.040.55 Supersedes EN 12470-3:2000+A1:2009, EN 12470-4:2000+A1:2009, EN 12470

6、-5:2003English Version Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009) Appareils lectromdicaux - Partie 2-56: Exigences particulires relatives la scurit fondam

7、entale et aux performances essentielles des thermomtres mdicaux pour mesurer la temprature de corps (ISO 80601-2-56:2009) Medizinische elektrische Gerte - Teil 2-56: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen de

8、r Krpertemperatur (ISO 80601-2-56:2009) This European Standard was approved by CEN on 16 September 2012. 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

9、. Up-to-date lists and bibliographical references concerning such national standards may be obtained on 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 t

10、ranslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC 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, Fi

11、nland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZA

12、TION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 80601-2-56:2012: EBS EN ISO 80601-2-56:2012EN ISO 8060

13、1-2-56:2012 (E) 3 Foreword The text of ISO 80601-2-56:2009 has been jointly prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and Sub-Committee IEC/SC 62D “Electromedical equipment” of the International Elec

14、trotechnical Commission (IEC) and has been taken over as EN ISO 80601-2-56:2012 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text

15、or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by October 2015. 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

16、for identifying any or all such patent rights. This document supersedes EN 12470-4:2000+A1:2009, EN 12470-5:2003, EN 12470-3:2000+A1:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requireme

17、nts of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Be

18、lgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Swit

19、zerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 80601-2-56:2009 has been approved by CEN as a EN ISO 80601-2-56:2012 without any modification. BS EN ISO 80601-2-56:2012EN ISO 80601-2-56:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the E

20、ssential 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 Directive 93/42/E

21、EC 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 the scope

22、 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 Clause(s)/sub-clause(s) of this International standard E

23、ssential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.11 7.2 Only the parts of ER 7.2 relating to safety in use for the patient are addressed. 201.11 7.3 Only the part of the first sentence relating to design is addressed. 201.7.9.2.14.101 7.5 Only the third paragraph of

24、 ER 7.5 is addressed. 201.11, 201.103 7.6 201.11 8.1 The part of ER 8.1 relating to easy handling is not addressed. 201.11 8.4 Validated processes for sterilization are required via the normative references to ISO 11134, ISO 11135, ISO 11137. 201.7.2.1.101 8.7 201.4, 201.4.2.101, 201.7, 201.7.9.2.10

25、1 e), 201.16, 201.101.1, 201.102.1, 201.103, 201.103.2 9.1 201.9, 201.12.1.101, 201.12.2, 201.15, 202 9.2 The 4th indent of ER 9.2 is not addressed. 201.11, 201.13 9.3 201.7.9.2.101 d), 201.12, 201.101, 201.102, 201.103 10.1 201.12.2 10.2 201.7 10.3 BS EN ISO 80601-2-56:2012EN ISO 80601-2-56:2012 (E

26、) 5 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this International standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 202 11.3.1201.14 12.1 201.14 12. a) 201.12 12.4 202 12.5 201.8 12.6 201.9 12.7.1 201.9 12.7.2201.9 12.7.3 201.8, 201.11, 201.15 12.7.4 201

27、.11, 201.15 12.7.5 201.7, 201.12.2, 201.15, 206 12.9 201.7, 201.7.2.1, 201.7.2.1.101, 201.7.2.2, 201.7.9 13.1 The requirement for information on the sales packaging is not addressed. 201.7, 201.7.2.1, 201.8, 201.9 13.2 201.7, 201.7.9.1 13.3 a) 201.7, 201.7.2.1.101 b) 13.3 b) 201.7.2.1.101 c) 13.3 c)

28、 201.7 13.3 d) This ER is only covered if the batch number is preceded by the word LOT. 201.7.2.1.101 d) 13.3 e) 201.7.2.1.101, 201.7.2.1.101 e) 13.3 f) 201.7, 201.7.2.1.101 f) 13.3 i) 201.7 13.3 j)201.7 13. k)201.7.2.1.101 c) 13.3 m) Presumption of conformity is only provided if symbols 4 to 7 are

29、utilized. 201.7, 201.7.9.1, 201.16 13.6 a) 201.7.9.2.101 c), 201.7.9.2.101 d) 13.6 b) 201.7, 201.7.9.2.101 e), 201.16 13.6 c) 201.7, 201.7.9.2.101 g), 201.16 13.6 d) 201.7, 201.16 13.6 f) 201.7, 201.7.2.9.2.101 j), 201.11, 201.16 13.6 h) The requirement for information on the packaging is not addres

30、sed. BS EN ISO 80601-2-56:2012EN ISO 80601-2-56:2012 (E) 6 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this International standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.7 13.6 i) 201.7.2.9.2.101 i) 13.6 n) 201.7.2.9.2.101 d) 13.6 p) 201.7.2.9.2.101

31、 k) 13.6 q) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 80601-2-56:2012ISO 80601-2-56:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword .v Introductionvi 201.1 * Scope, object and related sta

32、ndards1 201.1. 1 Scope .1 201.1. 2 Object.2 201.1. 3 Collateral standards .2 201.1. 4 Particular standards .2 201.2 Normative references .3 201.3 Terminology and definitions3 201.4 General requirements.6 201.4. 2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS .6 201.4. 2.101 Additional requi

33、rements for RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS.7 201.4. 3 ESSENTIAL PERFORMANCE7 201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE .7 201.4. 101 Environmental conditions of use 7 201.5 General requirements for testing of ME EQUIPMENT7 201.6 Classification of ME EQU

34、IPMENT and ME SYSTEMS.7 201.7 ME EQUIPMENT identification, marking and documents7 201.7. 2.1 Minimum requirements for marking on ME EQUIPMENT and interchangeable parts 8 201.7. 2.1.101 Additional requirements for minimum requirements for marking on ME EQUIPMENT and interchangeable parts, marking of

35、the packaging .8 201.7. 2.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts 8 201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts8 201.7. 4.3 Unit of measure.8 201.7. 4.3.101 Additional requirements for unit of measure.8 201.7. 9 ACCOMPA

36、NYING DOCUMENT9 201.7. 9.1 Additional general requirements.9 201.7. 9.2 Additional requirements for instructions for use9 201.7. 9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used material9 201.7. 9.2.101 Instructions for use 9 201.7. 9.101 Additional requirements for

37、ACCOMPANYING DOCUMENT 10 201.8 Protection against electrical HAZARDS from ME EQUIPMENT10 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS.10 201.10 Protection against unwanted and excessive radiation HAZARDs .10 201.11 Protection against excessive temperatures and other HAZ

38、ARDS10 201.12 Accuracy of controls and instruments and protection against hazardous outputs10 201.12. 1 Accuracy of controls and instruments.10 201.12. 1.101 Additional requirements for accuracy of controls and instruments .10 201.12. 2 USABILITY 11 201.12. 2.101 * Additional requirements for USABIL

39、ITY 11 201.13 HAZARDOUS SITUATIONS and fault conditions .11 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).11 BS EN ISO 80601-2-56:2012ISO 80601-2-56:2009(E) iv ISO 2009 All rights reserved201.15 Construction of ME EQUIPMENT11 201.16 ME SYSTEMS.11 201.17 * Electromagnetic compatibility of ME

40、EQUIPMENT and ME SYSTEMS.11 201.101 Laboratory performance requirements.11 201.101. 1 * General test requirements .11 201.101. 2 * Laboratory accuracy 12 201.101. 3 * Time response for a continuous clinical thermometer13 201.102 * Clinical accuracy validation.13 201.102. 1 Method13 201.102. 2 * Huma

41、n subject population requirements.14 201.102. 3 * Clinical bias calculation.15 201.102. 4 * Limits of agreement calculation15 201.102. 5 * Clinical repeatability calculation.16 201.103 * Probes, probe cable extenders and probe covers 16 201.103. 1 General .16 201.103. 2 Labeling17 202 Medical electr

42、ical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests .17 202.6.2.1.10 Compliance criteria.17 Annexes Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME

43、 SYSTEMS.19 Annex D (informative) Symbols on Marking.22 Annex AA (informative) Particular Guidance and rationale24 Annex BB (informative) REFERENCE TEMPERATURE SOURCE .37 Annex CC (informative) Environmental aspects 39 Annex DD (informative) Reference to the essential principles of safety and perfor

44、mance of medical devices in accordance with ISO/TR 16142 40 Bibliography 42 Alphabetized index of defined terms used in this particular standard .45 BS EN ISO 80601-2-56:2012ISO 80601-2-56:2009(E) ISO 2009 All rights reserved vForeword ISO (the International Organization for Standardization) is a wo

45、rldwide 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 committee has been established has the right to be represented o

46、n 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 electrotechnical standardization. International Standards are drafted

47、 in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standa

48、rd 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 80601-2-56 was prepare

49、d by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in cooperation with Subcommittee 62D, Electrical equipment, of Technical Committee IEC/TC 62: Electrical equipment in medical practice. ISO 80601 consists of the following parts, under the general title Medical electrical equipment: Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators Part 2-13: Particular requirements for basic safety and essential perfor