1、Medical devices Recognized essential principles of safety and performance of medical devicesPart 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standardsBS ISO 16142-2:2017BSI Standards PublicationWB11885_BSI_
2、StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 16142-2:2017.The UK participation in its preparation was entrusted to Technical Committee CH/210, Quality management and corresponding general aspects for medical devices.A list of orga
3、nizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 20
4、17ISBN 978 0 580 91385 3ICS 11.040.01Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text a
5、ffectedBRITISH STANDARDBS ISO 16142-2:2017 ISO 2017Medical devices Recognized essential principles of safety and performance of medical devices Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standardsDisp
6、ositifs mdicaux Principes essentiels reconnus de scurit et de performance des dispositifs mdicaux Partie 2: Principes essentiels gnraux et principes essentiels spcifiques supplmentaires pour tous les dispositifs mdicaux de DIV et directives sur le choix des normesINTERNATIONAL STANDARDISO16142-2Firs
7、t edition2017-08-21Reference numberISO 16142-2:2017(E)BS ISO 16142-2:2017ISO 16142-2:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwi
8、se in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh.
9、de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 16142-2:2017ISO 16142-2:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 44 Essential principles of safety and performance
10、of IVD medical devices 85 Use of standards and guides in support of the essential principles . 85.1 General approach to using standards 85.2 Types of standards useful to demonstrate compliance . 95.3 Risk management approach to demonstrating compliance .105.4 Phases of the IVD medical device life-cy
11、cle . 115.5 Use of standards during IVD medical device life-cycle phases .115.5.1 Design and development planning 115.5.2 Design and development including testing and validation 125.5.3 Regulatory premarket review . 125.5.4 Production 125.5.5 Post-production including IVD medical device use and post
12、-market surveillance .125.5.6 End of life . 125.6 Assessing the conformity of an IVD medical device 136 Essential principles and references to relevant standards and guides 136.1 Use of standards by authorities having jurisdiction 136.2 Manufacturers use of essential principles and references to rel
13、evant standards or guides 13Annex A (informative) Rationale and guidance .15Annex B (normative) Table relating essential principles to standards 17Annex C (informative) Website listings of other standards suitable for the medical device sector and for assessment purposes.34Annex D (informative) Refe
14、rence to the essential principles by International Standards .35Annex E (informative) Terminology Alphabetized index of defined terms .40Bibliography .41 ISO 2017 All rights reserved iiiContents PageBS ISO 16142-2:2017ISO 16142-2:2017(E)ForewordISO (the International Organization for Standardization
15、) is a worldwide 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 repr
16、esented on 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.The procedures used to deve
17、lop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO
18、/IEC Directives, Part 2 (see www.iso.org/directives).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. Details of any patent rights identified during t
19、he development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntar
20、y nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This d
21、ocument was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices.This document builds on ISO 16142-1, which cancels and replaces ISO/TR 16142:2006.A list of all parts in the ISO 16142 series can be found on the ISO website.iv ISO 2017 A
22、ll rights reservedBS ISO 16142-2:2017ISO 16142-2:2017(E)IntroductionStandards and standardization processes can be made more effective by developing a better understanding of the needs and requirements of those who use or who are affected by standards. Improvements in standards will contribute to gl
23、obal harmonization efforts at all levels.Continuous innovation is key to the advancement of medical device technology, contributing to more effective healthcare. Ideally, standards supporting or referenced in regulatory requirements are developed and applied in such a way as to allow product innovat
24、ion by industry while assuring safety and effectiveness.The timely development of medical device standards and their periodic revision make medical device standards effective and efficient tools for supporting regulatory systems and for achieving globally compatible regulation.Voluntary standards an
25、d guides can assist manufacturers to comply with legal requirements. If the standards are accepted within a given regulatory system, compliance with such standards can be deemed to satisfy the legal requirements. The regulatory acceptance does not, of itself, imply that such standards are mandatory.
26、Medical device standards represent a consensus on requirements that foster innovation while protecting public health.Harmonized compliance with the regulations, a key element of timely market introduction of advance technology, can be facilitated by the appropriate use of relevant medical device sta
27、ndards. This is based on the premise that standards are based on experience or, in other words, are retrospective, innovation can present unanticipated challenges to experience, rigid, mandatory, application of standards can deter innovation, operation of a quality management system, subject to asse
28、ssment, has become widely acknowledged as a fundamental and effective tool for the protection of public health, quality management systems include provisions that address both innovation and experience, and such provisions of quality management systems include field experience, risk analysis and ris
29、k management, phased reviews, documentation and record keeping, as well as the use of product and process standards.The essential principles of safety and performance of medical devices were originally developed by the Global Harmonization Task Force (GHTF), revised in 2012 to harmonize regulatory r
30、equirements for medical devices worldwide, and now archived by the International Medical Device Regulators Forum (IMDRF). Thus, an update of the original ISO/TR 16142:2006, based on those essential principles, was needed to keep the document in line with the updated essential principles.In discussin
31、g the revision of ISO/TR 16142:2006, ISO/TC 210 decided that the information included was, at the time of writing, in a state of consensus between the stakeholders and had matured enough to elevate the document from a Technical Report (TR) to an International Standard.In this document, the following
32、 print types are used: requirements and definitions: roman type; informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; terms defined in Clause 3: italics. ISO 2017 All rights reserved vBS ISO 161
33、42-2:2017ISO 16142-2:2017(E)In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.For the purposes of this document, the auxiliary verb “shall” means that compliance with a requirement or a test is mandatory for compli
34、ance with this document, “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this document, “may” is used to describe a permissible way to achieve compliance with a requirement or test, and “must” is used to describe an external constra
35、int, but is not mandatory for compliance with this document.An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.vi ISO 2017 All rights reservedBS ISO 16142-2:2017Medical devi
36、ces Recognized essential principles of safety and performance of medical devices Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards1 ScopeThis document, which includes the essential principles of sa
37、fety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This document identifies and describes the six gene
38、ral essential principles of safety and performance (see Table B.1) that apply to all medical devices, including IVD medical devices (in vitro diagnostic).This document also identifies and describes the additional essential principles of safety and performance which need to be considered during the d
39、esign and manufacturing process, which are relevant to IVD medical devices.NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others.This document is intended
40、for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requiremen
41、ts of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 2859 (all parts), Sampling procedures for inspection by attributesISO 3951 (all parts), Sampling procedures for insp
42、ection by variablesISO 11135, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 11137 (all parts), Sterilization of health care products RadiationISO 11138 (all parts), Sterilization
43、 of health care products Biological indicatorsISO 11140 (all parts), Sterilization of health care products Chemical indicatorsISO 11607 (all parts), Packaging for terminally sterilized medical devicesISO 11737 (all parts), Sterilization of medical devices Microbiological methodsISO/TS 13004, Sterili
44、zation of health care products Radiation Substantiation of selected sterilization dose: Method VDmaxSDISO 13408 (all parts), Aseptic processing of health care productsINTERNATIONAL STANDARD ISO 16142-2:2017(E) ISO 2017 All rights reserved 1BS ISO 16142-2:2017ISO 16142-2:2017(E)ISO 13485, Medical dev
45、ices Quality management systems Requirements for regulatory purposesISO 14161, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of resultsISO 14644 (all parts), Cleanrooms and associated controlled environmentsISO 14698 (all parts), Clean
46、rooms and associated controlled environments Biocontamination controlISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesISO 14971, Medical
47、devices Application of risk management to medical devicesISO 15193, In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement proceduresISO 15194, In vitro diagnostic medical devices Measurement of
48、 quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentationISO 15195, Laboratory medicine Requirements for reference measurement laboratoriesISO 15197, In vitro diagnostic test systems Requirements for blood-glucose monitorin
49、g systems for self-testing in managing diabetes mellitusISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 15882, Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of resultsISO 16269 (all parts), Statistical interpretation of dataISO 17511, In vitro diagnostic medical devices Measurement of quantities in biological samples
