1、BSI Standards PublicationBS EN ISO 15197:2015In vitro diagnostic test systems Requirements for blood-glucose monitoring systemsfor self-testing in managingdiabetes mellitusBS EN ISO 15197:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 15197:2015. It is
2、 identical to ISO 15197:2013. It supersedes BS EN ISO 15197:2013 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained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 purp
3、ort to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 90800 2ICS 11.040.55; 11.100.10Compliance with a British Standard cannot confer immunity fromlegal
4、 obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15197 June 2015 ICS 11.100.10 Supersedes EN ISO
5、15197:2013English 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 vitro - Exigences relatives aux systmes dautosurveillance de la glycmie destins la prise en
6、charge du diabte sucr (ISO 15197:2013) Testsysteme fr die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme 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 Re
7、gulations 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 on application to the CEN-CENELEC Management Centre or to any CEN me
8、mber. 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-CENELEC Management Centre has the same status as the official versions.
9、 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Polan
10、d, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation i
11、n any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15197:2015 EBS EN ISO 15197:2015EN ISO 15197:2015 (E) 3 Foreword The text of ISO 15197:2013 has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems”
12、of the International Organization for Standardization (ISO) and has been taken over 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
13、 publication of an identical text or by endorsement, at the latest by December 2015, 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 CENE
14、LEC shall not be held responsible for identifying any or all such patent rights. This 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 Dire
15、ctive(s). For relationship with EU Directive, see informative Annex ZA, which is an 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) lis
16、ted below applies. For dated references, only the edition cited applies. However, 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 acknow
17、ledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard 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 refe
18、renced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 15197:2015EN ISO 15197:2015 (E) 4 Table Correlation between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 Equivalen
19、t dated standard EN ISO ISO 13485 EN ISO 13485:2012 + AC:2012 ISO 13485:2003 + 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:
20、2009 ISO 18113-5 EN ISO 18113-5:2011 ISO 18113-5:2009 ISO 23640 EN ISO 23640:2014 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 61
21、326-1:2012 IEC 61326-2-6 EN 61326-2-6:2013 IEC 61326-2-6:2012 IEC 62366 EN 62366:2008 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, Belgi
22、um, 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, Switzer
23、land, Turkey and the United Kingdom. Endorsement notice The text of ISO 15197:2013 has been approved by CEN as EN ISO 15197:2015 without any modification. BS EN ISO 15197:2015EN ISO 15197:2015 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of
24、EU Directive 98/79/EC 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 Directive 98/79/EC in vitro diagnostic medical devices. Once this standard is c
25、ited 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 normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
26、conformity with the corresponding Essential Requirements of that Directive and associated EFTA Regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 98/79/EC. This means that r
27、isks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements Part A:
28、 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means th
29、at it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Directive 98/79/EC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 98/79/EC Qualifying remarks/notes 4.3 A.2 Referenced clause covers only the first bullet poin
30、t of the ER. Risk management of blood glucose monitoring instrument is not covered by the referenced clause. Directive 98/79/EC requires manufacturers to eliminate or reduce risks as far as possible. For managing risks associated with in vitro diagnostic medical devices EN ISO 14971:2012 should be a
31、pplied. 5.11, 5.12 B.3.3 Referenced clauses cover only the temperature (5.11) and humidity (5.12) aspects of the ER (in second bullet) 4.4 B.3.6 6, 7.2 B.4.1 This ER is covered when accuracy limits are stated by the manufacturer in the IFU. 4.5 B.7.2 WARNING Other requirements and other EU Directive
32、s may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 15197:2015ISO 15197:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 Design and development 84.1 General requirement
33、s . 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 General requirements 105.2 Protection against electric shock . 115.3 Protection against mechanical hazards 115.4 E
34、lectromagnetic 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 125.9 Performance test 125.10 Mechanical resistance to vibration and shock 125.11 Equipment temperature exposure li
35、mits 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 196.4 Influence quantities . 256.5 Stability of reagents and materials . 307 Information supplied by the manufact
36、urer 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 Acceptance criteria and evaluation of results . 328.3 Selection and preparation of subjects 328.4 Execution of study pr
37、otocol 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 interfering substances 35Annex B (informative) Traceability chain 36Annex C (informative) Rationale for the analytic
38、al performance requirements 38Bibliography .45BS EN ISO 15197:2015ISO 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 throug
39、h ISO 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 collaborat
40、es 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.
41、 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
42、ocument may be the 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 e
43、dition (ISO 15197:2003), the clauses, subclauses and annexes of which have been technically revised.iv ISO 2013 All rights reservedBS EN ISO 15197:2015ISO 15197:2013(E)IntroductionBlood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by d
44、iabetes mellitus. Diabetes mellitus is caused 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 t
45、o monitor and take action to control the concentration 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 procedure
46、s for demonstrating conformance to this International 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 Internati
47、onal Standard to communicate the analytical 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 produc
48、e measurement results that agree with true 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 moni
49、toring 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 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 edition are the result of improvements in technology since publication of the f
