EN ISO 15197-2013 0000 In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus《体外诊断试验系统 糖尿病症管理中自测用血糖监测系统的.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 15197:2013In vitro diagnostic testsystems Requirements forblood-glucose monitoringsystems for self-testing inmanaging diabetes mellitus(ISO 15197:2013)Copyright Europea

2、n Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15197:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO15197:2013. It supersedes BS EN ISO 1

3、5197:2003 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained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 contrac

4、t. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 68839 3ICS 11.040.55Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authorit

5、y of theStandards Policy and Strategy Committee on 30 June 2013.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STAN

6、DARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15197 May 2013 ICS 11.100.10 Supersedes EN ISO 15197:2003English Version In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) Systmes dessais de diagnostic in v

7、itro - Exigences relatives aux systmes dautosurveillance de la glycmie destins la prise en charge du diabte sucr (ISO 15197:2013) Testsysteme fr die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur Eigenanwendung beim Diabetes mellitus (ISO 15197:2013) This European Standard was appr

8、oved by CEN on 15 May 2013. 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 st

9、andards 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 translation under the responsibility of a CEN member into its own language and

10、 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, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungar

11、y, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, 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

12、 Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15197:2013: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction o

13、r networking permitted without license from IHS-,-,-BS EN ISO 15197:2013EN ISO 15197:2013 (E) 3 Foreword This document (EN ISO 15197:2013) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems“ in collaboration with the Technical Commit

14、tee CEN/TC 140 “In vitro diagnostic 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 or by endorsement, at the latest by November 2013, and conflicting national standards shal

15、l be withdrawn at the latest by November 2016. 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 for identifying any or all such patent rights. This document supersedes EN ISO 15197:2

16、003. 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 EU Directive(s). For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Acco

17、rding to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany

18、, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15197:2013 has been approved by CEN as EN ISO 15197:2013

19、 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 15197:2013EN ISO 15197:2013 (E) 4 Annex ZA (informative) Relationship between this European S

20、tandard and the Essential Requirements of EU Directive 98/79/EC in vitro diagnostic 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 t

21、he New Approach Directive 98/79/EC in vitro diagnostic 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 t

22、able 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 Directive 98/79/EC in vitro diagnostic medical

23、 devices Clauses of this international Standard Essential requirements (ERs) of Directive 98/79/EC Qualifying Comments/Notes 4.2, 6 A.3 4.3, 4.4 A.4 Aspects related to mechanical stress are not covered 4.3, 4.4, 6.5, 7 A.5 Packaging aspects are not covered. 4.3, 5.2, 5.3, 5.4, 5.5, 5.6, 5.8, 5.10, 5

24、.11, 5.12 B.3.3 5.7 B.3.4 4.4 B.3.6 6, 7 B.4.1 6 B.6.1 5.2 B.6.3 5.3, 5.6 B.6.4.1 “Life time resistance to mechanical stress” is not covered. 5.2 B.6.4.4 Clause 5.2 only partially covers this ER, as it deals only with electrical terminals and connectors. 4.4, 7, 8 B.7.1 7 B.8.1 The sixth paragraph o

25、f this ER (translation into other languages) is not covered. 7 B.8.2 Covered by reference to EN ISO 18113-1. 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 15197:2013E

26、N ISO 15197:2013 (E) 5 7 B.8.3 This aspect is covered by normative reference to EN ISO 18113-4 and EN ISO 18113-5. However, essential requirement B.8.3 of Directive 98/79/EC should be consulted for a comprehensive list of the information required 7 B.8.4 Not all the requirements of ER B.8.4 are cove

27、red, but only those required by EN ISO 18113-1, EN ISO 18113-4 and EN ISO 18113-5, related to IVD medical devices for self testing 7 B.8.4(a) If the manufacturer is not located in the EU, the manufacturer is required to designate an “EC Authorised Representative” established in the EU. In such cases

28、 and to comply with this ER, the name and address of the Authorised Representative are required 7 B.8.4(d) Full compliance with this ER requires the use of the symbol LOT and the symbol SN, as applicable. 7 B.8.6 Covered by normative reference to EN ISO 18113-4 and EN ISO 18113-5. 4.2, 7 B.8.7 Not a

29、ll the requirements of this ER are covered, but only those required by the labelling standards EN ISO 18113-1, EN ISO 18113-4 and EN ISO 18113-5, related to IVD medical devices for self testing WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the

30、scope of this 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 15197:2013ISO 15197:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction

31、 v1 Scope . 12 Normative references 13 Terms and definitions . 24 Design and development 84.1 General requirements . 84.2 Metrological traceability . 84.3 Safety and risk management . 94.4 Ergonomics and human factors . 104.5 User verification requirements 105 Safety and reliability testing .105.1 G

32、eneral requirements 105.2 Protection against electric shock . 115.3 Protection against mechanical hazards 115.4 Electromagnetic compatibility . 115.5 Resistance to heat 115.6 Resistance to moisture and liquids 115.7 Protection against liberated gases, explosion and implosion125.8 Meter components 12

33、5.9 Performance test 125.10 Mechanical resistance to vibration and shock 125.11 Equipment temperature exposure limits for storage .135.12 Equipment humidity exposure limits for storage 136 Analytical performance evaluation 146.1 General requirements 146.2 Measurement precision 166.3 System accuracy

34、196.4 Influence quantities . 256.5 Stability of reagents and materials . 307 Information supplied by the manufacturer 307.1 General requirements 307.2 Performance characteristics. 317.3 Options for supplying instructions for use 318 User performance evaluation 318.1 General requirements 318.2 Accept

35、ance criteria and evaluation of results . 328.3 Selection and preparation of subjects 328.4 Execution of study protocol 328.5 Glucose reference values . 338.6 Human factors 338.7 Data analysis and presentation of results . 338.8 Evaluation of instructions for use 34Annex A (informative) Possible int

36、erfering substances 35Annex B (informative) Traceability chain 36Annex C (informative) Rationale for the analytical performance requirements 38Bibliography .45Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted

37、without license from IHS-,-,-BS EN ISO 15197:2013ISO 15197:2013(E)ForewordISO (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 c

38、ommittees. 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 closely with t

39、he 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. Draft Internatio

40、nal 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 document may be th

41、e subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 15197 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.This second edition cancels and replaces the first edition (ISO 15197

42、:2003), the clauses, subclauses and annexes of which have been technically revised.iv ISO 2013 All rights reservedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 15197:

43、2013ISO 15197:2013(E)IntroductionBlood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by diabetes mellitus. Diabetes mellitus is caused by a deficiency in insulin secretion or by insulin resistance leading to abnormally high concentratio

44、ns of glucose in the blood, which may result in acute and chronic health complications. When used properly, a glucose monitoring system allows the user to monitor and take action to control the concentration of glucose present in the blood.This International Standard is intended for blood-glucose mo

45、nitoring systems used by lay persons. The primary objectives are to establish requirements that result in acceptable performance and to specify procedures for demonstrating conformance to this International Standard.Minimum performance criteria for blood-glucose monitoring systems were established f

46、rom the analytical requirements (precision and trueness) for individual glucose measurement results. “System accuracy” is the term used in this International Standard to communicate the analytical capability of a blood-glucose monitoring system to the intended users (i.e. lay persons), who would not

47、 be familiar with metrological terms commonly used in laboratory medicine. System accuracy describes the ability of a glucose monitoring system to produce measurement results that agree with true glucose values when the system is used as intended. The concept of “system accuracy” includes measuremen

48、t bias and measurement precision.The requirements for system accuracy are based on three considerations: the effectiveness of current technology for monitoring patients with diabetes mellitus; recommendations of diabetes researchers as well as existing product standards and regulatory guidelines; an

49、d the state-of-the-art of blood-glucose monitoring technology.In arriving at the performance requirements specified in the second edition of this International Standard, desirable goals had to be weighed against the capabilities of existing blood-glucose monitoring technology. The revised performance criteria in this ed