ISO 16142-2:2017

Medical 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 standards

ISO 16142-2:2017, which includes the essential principles 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 document identifies and describes the six general essential principles of safety and performance (see Table B.1) that apply to all medical devices, including IVD medical devices (in vitro diagnostic). ISO 16142-2:2017 also identifies and describes the additional essential principles of safety and performance which need to be considered during the design 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. ISO 16142-2:2017 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.

Dispositifs médicaux — Principes essentiels reconnus de sécurité et de performance des dispositifs médicaux — Partie 2: Principes essentiels généraux et principes essentiels spécifiques supplémentaires pour tous les dispositifs médicaux de DIV et directives sur le choix des normes

General Information

• Status: Withdrawn
• Publication Date: 20-Aug-2017
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: ISO/TC 210 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: ISO/TC 210 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9599 - Withdrawal of International Standard
• Start Date: 18-Aug-2023
• Completion Date: 18-Aug-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 16142-2
First edition
2017-08
Medical 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 standards
Dispositifs médicaux — Principes essentiels reconnus de sécurité et de
performance des dispositifs médicaux —
Partie 2: Principes essentiels généraux et principes essentiels
spécifiques supplémentaires pour tous les dispositifs médicaux de DIV
et directives sur le choix des normes
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2017 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 4
4 Essential principles of safety and performance of IVD medical devices .8
5 Use of standards and guides in support of the essential principles .8
5.1 General approach to using standards . 8
5.2 Types of standards useful to demonstrate compliance . 9
5.3 Risk management approach to demonstrating compliance .10
5.4 Phases of the IVD medical device life-cycle .11
5.5 Use of standards during IVD medical device life-cycle phases .11
5.5.1 Design and development planning .11
5.5.2 Design and development including testing and validation .12
5.5.3 Regulatory premarket review .12
5.5.4 Production .12
5.5.5 Post-production including IVD medical device use and post-
market surveillance .12
5.5.6 End of life .12
5.6 Assessing the conformity of an IVD medical device .13
6 Essential principles and references to relevant standards and guides .13
6.1 Use of standards by authorities having jurisdiction .13
6.2 Manufacturers’ use of essential principles and references to relevant standards
or guides .14
Annex A (informative) Rationale and guidance .15
Annex B (normative) Table relating essential principles to standards .17
Annex C (informative) Website listings of other standards suitable for the medical device
sector and for assessment purposes.34
Annex D (informative) Reference to the essential principles by International Standards .35
Annex E (informative) Terminology — Alphabetized index of defined terms .40
Bibliography .41
Foreword
ISO (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 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 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, 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/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 the 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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's 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 document 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 – All rights reserved

Introduction
Standards 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 global 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 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 regulation.
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
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 relevant 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 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 experience, risk analysis and risk
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 requirements for
medical devices worldwide, and now archived by the International Medical Device Regulators Forum
(IMDRF). Thus, an update of the original ISO/TR 16142:2006, based on those essential principles, was
needed to keep the document in line with the updated essential principles.
In 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 document, 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: italics.
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 compliance 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 constraint, 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 reserved

INTERNATIONAL STANDARD ISO 16142-2:2017(E)
Medical 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 standards
1 Scope
This document, which includes the essential principles 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 document identifies and describes the six general 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 design 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 for use as guidance by medical device manufacturers, standards development
organizations, authorities having jurisdiction, and conformity assessment bodies.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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
...