DIN EN ISO 15197-2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197 2013) German ve.pdf

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1、December 2015 English price group 22No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.100.10!%Iw2“2388415www.din.d

2、eDIN EN ISO 15197In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013);English version EN ISO 15197:2015,English translation of DIN EN ISO 15197:2015-12Testsysteme fr die In-vitro-Diagnostik Anforderungen an

3、 Blutzuckermesssysteme zur Eigenanwendung bei Diabetes mellitus (ISO 15197:2013);Englische Fassung EN ISO 15197:2015,Englische bersetzung von DIN EN ISO 15197:2015-12Systmes dessais de diagnostic in vitro Exigences relatives aux systmes dautosurveillance de la glycmie destins la prise en charge du d

4、iabte sucr (ISO 15197:2013);Version anglaise EN ISO 15197:2015,Traduction anglaise de DIN EN ISO 15197:2015-12SupersedesDIN EN ISO 15197:2013-11See start of applicationwww.beuth.deDocument comprises 56 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be co

5、nsidered authoritative.12.15DIN EN ISO 15197:2015-12 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2015-12-01. For DIN EN ISO 15197:2013-11 there is a transition period ending on 2018-06-30. National foreword This document (EN ISO 15197:20

6、15) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems” in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices”. The responsible German body involved in its preparation was DIN-Normenausschuss Mediz

7、in (DIN Standards Committee Medicine), Working Committee NA 063-03-11 AA Patientennahe Sofortdiagnostik (POCT). The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3534-1 DIN ISO 3534-1 ISO 5725-1 DIN ISO 5725-1 ISO 5725-2 DIN ISO 5725-2 IS

8、O 5725-3 DIN ISO 5725-3 ISO 13485 DIN EN ISO 13485 ISO 14971 DIN EN ISO 14971 ISO 15194 DIN EN ISO 15194 ISO 17511 DIN EN ISO 17511 ISO 18113-1 DIN EN ISO 18113-1 ISO 18113-4 DIN EN ISO 18113-4 ISO 18113-5 DIN EN ISO 18113-5 ISO 18153 DIN EN ISO 18153 ISO 23640 DIN EN ISO 23640 IEC 60068-2-64 DIN EN

9、 60068-2-64 IEC 61010-1 DIN EN 61010-1 IEC 61326-1 DIN EN 61326-1 IEC 61326-2-6 DIN EN 61326-2-6 IEC 62366 DIN EN 62366 Amendments This standard differs from DIN EN ISO 15197:2013-11 as follows: a) the European Foreword and Annex ZA have been revised. Previous editions DIN EN ISO 15197: 2004-05, 201

10、3-09, 2013-11 DIN EN ISO 15197 Corrigendum 1: 2005-06 DIN EN ISO 15197:2015-12 3 National Annex NA (informative) Bibliography DIN EN 60068-2-64, Environmental testing Part 2-64: Tests Test Fh: Vibration, broadband random and guidance DIN EN 61010-1, Safety requirements for electrical equipment for m

11、easurement, control, and laboratory use Part 1: General requirements DIN EN 61326-1, Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements DIN EN 61326-2-6, Electrical equipment for measurement, control and laboratory use EMC requirements Part

12、 2-6: Particular requirements In vitro diagnostic (IVD) medical equipment DIN EN 62366, Medical devices Application of usability engineering to medical devices DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14971, Medical devices Applicat

13、ion of risk management to medical devices DIN EN ISO 15194, In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation DIN EN ISO 17511, In vitro diagnostic medical devices M

14、easurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials DIN EN ISO 18113-1, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements DIN EN ISO

15、 18113-4, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing DIN EN ISO 18113-5, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instrument

16、s for self-testing DIN EN ISO 18153, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials DIN EN ISO 23640, In vitro diagnostic medical devices Eval

17、uation of stability of in vitro diagnostic reagents DIN ISO 3534-1, Statistics Vocabulary and symbols Part 1: General statistical terms and terms used in probability DIN ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions DIN IS

18、O 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method DIN EN ISO 15197:2015-12 4 DIN ISO 5725-3, Accuracy (trueness and precision) of measurement methods and resu

19、lts Part 3: Intermediate measures of the precision of a standard measurement method EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15197 June 2015 ICS 11.100.10 Supersedes EN ISO 15197:2013 English Version In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems

20、 for self-testing in managing diabetes mellitus (ISO 15197:2013) Systmes dessais de diagnostic in vitro - 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 Blutzuckermes

21、ssysteme zur Eigenanwendung bei Diabetes mellitus (ISO 15197:2013) This European Standard was approved by CEN on 3 June 2015. 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 w

22、ithout any alteration. 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 oth

23、er language made by translation 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,

24、 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, Switzerland, Turkey and United Kingdom. EUROPEAN COMM

25、ITTEE FOR STANDARDIZATION COMIT EUROPEN D E NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15197:2015 E Content

26、s PageForeword 3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 74 Design and development . 134.1 General requirements 134.2 Metrological traceability 134.3 Safety and risk management 144.4 Ergonomics and human factors . 154.5 User verification requirements 155 Safety and

27、reliability testing .155.1 General requirements 155.2 Protection against electric shock . 165.3 Protection against mechanical hazards 165.4 Electromagnetic compatibility . 165.5 Resistance to heat 165.6 Resistance to moisture and liquids 165.7 Protection against liberated gases, explosion and implos

28、ion175.8 Meter components 175.9 Performance test 175.10 Mechanical resistance to vibration and shock 175.11 Equipment temperature exposure limits for storage .185.12 Equipment humidity exposure limits for storage 186 Analytical performance evaluation 196.1 General requirements 196.2 Measurement prec

29、ision 216.3 System accuracy 246.4 Influence quantities . 306.5 Stability of reagents and materials . 357 Information supplied by the manufacturer 357.1 General requirements 357.2 Performance characteristics. 367.3 Options for supplying instructions for use 368 User performance evaluation 368.1 Gener

30、al requirements 368.2 Acceptance criteria and evaluation of results .378.3 Selection and preparation of subjects 378.4 Execution of study protocol 378.5 Glucose reference values . 388.6 Human factors 388.7 Data analysis and presentation of results . 388.8 Evaluation of instructions for use 39Annex A

31、 (informative) Possible interfering substances .40Annex B (informative) Traceability chain .41Annex C (informative) Rationale for the analytical performance requirements .43Bibliography .51Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directi

32、ve 98/79/EC 50 2 EN ISO 15197:2015 (E) DIN EN ISO 15197:2015-12Foreword The text of ISO 15197:2013 has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO) and has been taken ove

33、r as EN ISO 15197:2015 by Technical Committee 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 December 201

34、5, and conflicting national standards shall be withdrawn at the latest by June 2018. 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. T

35、his document supersedes EN ISO 15197:2013. 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 a

36、n integral part of this document. The following referenced documents are indispensable for the application of this document. For undated references, the edition of the referenced document (including any amendments) listed below applies. For dated references, only the edition cited applies. However,

37、for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standar

38、d text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in who

39、le or in part) to which they apply. 3EN ISO 15197:2015 (E) DIN EN ISO 15197:2015-12Table Correlation between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 Equivalent dated standard EN ISO ISO 13485 EN ISO 13485:2012 + AC:2012 ISO 13485:2003 +

40、Cor. 1:2009 ISO 14971 EN ISO 14971:2012 ISO 14971:2007, Corrected version 2007-10-01 ISO 17511 EN ISO 17511:2003 ISO 17511:2003 ISO 18113-1 EN ISO 18113-1:2011 ISO 18113-1:2009 ISO 18113-4 EN ISO 18113-4:2011 ISO 18113-4:2009 ISO 18113-5 EN ISO 18113-5:2011 ISO 18113-5:2009 ISO 23640 EN ISO 23640:20

41、14 ISO 23640:2011 IEC 60068-2-64 EN 60068-2-64:2008 IEC 60068-2-64:2008 IEC 61010-1 EN 61010-1:2010 IEC 61010-1:2010 + Cor. : 2011 IEC 61010-2-101 EN 61010-2-101:2002 IEC 61010-2-101:2002 IEC 61326-1 EN 61326-1:2013 IEC 61326-1:2012 IEC 61326-2-6 EN 61326-2-6:2013 IEC 61326-2-6:2012 IEC 62366 EN 623

42、66:2008 IEC 62366:2007 EN 13612 EN 13612:2002 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Form

43、er 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 the United Kingdom. Endorsement notice The text of ISO 15197:

44、2013 has been approved by CEN as EN ISO 15197:2015 without any modification. 4 EN ISO 15197:2015 (E) DIN EN ISO 15197:2015-12IntroductionBlood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by diabetes mellitus. Diabetes mellitus is caus

45、ed by a deficiency in insulin secretion or by insulin resistance leading to abnormally high concentrations 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 co

46、ncentration of glucose present in the blood.This International Standard is intended for blood-glucose monitoring 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 Int

47、ernational Standard.Minimum performance criteria for blood-glucose monitoring systems were established from 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

48、 capability of a blood-glucose monitoring system to the intended users (i.e. lay persons), who would not 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

49、glucose values when the system is used as intended. The concept of “system accuracy” includes measurement 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; and the state-of-the-art of blood-glucose monitoring technology.In arriving at the perf