1、BSI Standards PublicationBS ISO 16142-1:2016Medical devices Recognizedessential principles of safetyand performance of medicaldevicesPart 1: General essential principles andadditional specific essential principles for allnon-IVD medical devices and guidance onthe selection of standardsBS ISO 16142-1
2、:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 16142-1:2016.It supersedes PD ISO/TR 16142:2006 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/210, Quality management and corresponding generalaspects for
3、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 contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published
4、by BSI Standards Limited 2016ISBN 978 0 580 84345 7ICS 11.040.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2016.Amendments/corrigenda issued since pu
5、blicationDate T e x t a f f e c t e dBS ISO 16142-1:2016 ISO 2016Medical devices Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selectio
6、n of standardsDispositifs mdicaux Lignes directrices pour le choix des normes correspondant aux principes essentiels reconnus de scurit et de performance des dispositifs mdicauxINTERNATIONAL STANDARDISO16142-1First edition2016-03-01Reference numberISO 16142-1:2016(E)BS ISO 16142-1:2016ISO 16142-1:20
7、16(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or po
8、sting 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. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41
9、22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 16142-1:2016ISO 16142-1:2016(E)Foreword ivIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 84 Essential principles of safety and performance of medical devices 115 Use of standards and guides in support of the essential princip
10、les 125.1 Types of standards useful to demonstrate compliance 125.2 General approach to using standards . 135.3 Risk management approach to demonstrating compliance .145.4 Phases of the medical device life-cycle . 145.5 Use of standards during medical device life-cycle phases155.5.1 Design and devel
11、opment planning 155.5.2 Design and development including testing and validation 155.5.3 Regulatory pre-market review . 165.5.4 Production 165.5.5 Post-production including medical device use and post-market surveillance .165.5.6 End of life . 165.6 Assessing the conformity of a medical device 166 Es
12、sential principles and references to relevant standards and guides 176.1 Use of standards by authorities having jurisdiction 176.2 Manufacturers use of essential principles and references to relevant standards or guides 17Annex A (informative) Rationale and guidance .19Annex B (normative) Table rela
13、ting essential principles to standards 21Annex C (informative) Website listings of other standards suitable for the medical device sector and for assessment purposes.40Annex D (informative) Reference to the essential principles by International Standards .41Annex E (informative) Terminology alphabet
14、ized index of defined terms 46Bibliography .47 ISO 2016 All rights reserved iiiContents PageBS ISO 16142-1:2016ISO 16142-1:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Interna
15、tional 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 on that committee. International organizations, governmental and non-governmental, in liaison with
16、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 develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, P
17、art 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/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the
18、 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 the development of the document will be in the Introduction and/or on the ISO list of patent declarations re
19、ceived (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 meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs a
20、dherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 210, Quality management and corresponding general aspects for medical devices.This first edition of ISO 16142-1 can
21、cels and replaces ISO/TR 16142:2006, which has been technically revised with the following most significant changes: the technical report was converted to a standard to improve the usefulness of the document to authorities having jurisdiction; the standard has been developed in two parts, one for no
22、n-IVD (in vitro diagnostic) medical devices and one for IVD medical devices; the essential principles were harmonized with the most recent Global Harmonization Task Force recommendation5, as well as other major jurisdictions (e.g. U.S. FDA regulation the relevant aspects of the draft European Medica
23、l Device Regulation6); a much more thorough mapping of published reference standards to the essential principles has been included; this part of ISO 16142 also includes a more comprehensive description of the use of standards as a tool to demonstrate that a medical device is clinically effective and
24、 performs in a safe manner where the medical benefits of the use of the medical device outweigh the risk of the use to the patient; this part of ISO 16142 also includes an informative annex as a template for writers of medical device related standards where the content of their standard is mapped to
25、 the essential principles.ISO 16142 consists of the following parts, under the general title Medical devices Recognized essential principles of safety and performance of medical devices: Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices
26、 and guidance on the selection of standardsiv ISO 2016 All rights reservedBS ISO 16142-1:2016ISO 16142-1:2016(E)The following parts are under preparation: Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of st
27、andards ISO 2016 All rights reserved vBS ISO 16142-1:2016ISO 16142-1:2016(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 w
28、ill contribute to global harmonization efforts at all levels.Continuous innovation is the 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
29、to allow product innovation 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 regulatio
30、n.Voluntary standards and 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
31、standards are mandatory.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 rel
32、evant medical device standards. 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
33、 system, subject to assessment, 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 experienc
34、e, risk analysis and 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, originally developed by the Global Harmonization Task Force (GHTF), revised in 2012 to harmoni
35、ze regulatory requirements for medical devices worldwide, and now archived by the International Medical Device Regulators Forum (IMDRF). Thus, an update of the original ISO/TR 16142, based on those essential principles, was needed to keep the document in line with the updated essential principles.In
36、 discussing 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 part of ISO 1
37、6142, the following 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: bold.vi ISO 2016 All rights re
38、servedBS ISO 16142-1:2016ISO 16142-1:2016(E)In this part of ISO 16142, 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 part of ISO 16142, the auxiliary verb “shall” means that compliance with a requirement
39、 or a test is mandatory for compliance with this part of ISO 16142, “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this part of ISO 16142, and “may” is used to describe a permissible way to achieve compliance with a requirement or
40、test.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.The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing organizations may need a
41、 transitional period following publication of a new, amended or revised ISO publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be ado
42、pted for implementation nationally not earlier than three years from the date of publication for equipment newly designed and not earlier than five years from the date of publication for equipment already in production. ISO 2016 All rights reserved viiBS ISO 16142-1:2016BS ISO 16142-1:2016Medical de
43、vices Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards1 ScopeThis part of ISO 16142, which includes the essential p
44、rinciples of safety 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 part of ISO 16142 identifies an
45、d describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).This part of ISO 16142 also identifies and describes the additional essential principles of safety and performance which need to be consid
46、ered during the design and manufacturing process, which are relevant to medical devices other than IVD medical devices. Future ISO 16142-2 is intended to identify and describe the essential principles of safety and performance, which need to be considered during the design and manufacturing process
47、of 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 part of ISO 16142 is intended for use as guidance by medical device manuf
48、acturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the e
49、dition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1135 (all parts), Transfusion equipment for medical useISO 3107, Dentistry Zinc oxide/eugenol cements and zinc oxide/non-eugenol cementsISO 3826 (all parts), Plastics collapsible containers for human blood and blood componentsISO 5356 (all parts), Anaesthetic and respiratory equipment Conical connectorsISO 5359, Anaesthetic and respiratory equipment Low-pressure hose assemblies for use wi
