ISO 16142-1:2016

INTERNATIONAL ISO
STANDARD 16142-1
First edition
2016-03-01
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 and
guidance on the selection of standards
Dispositifs médicaux — Lignes directrices pour le choix des normes
correspondant aux principes essentiels reconnus de sécurité et de
performance des dispositifs médicaux
Reference number
©
ISO 2016
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved

Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 8
4 Essential principles of safety and performance of medical devices .11
5 Use of standards and guides in support of the essential principles .12
5.1 Types of standards useful to demonstrate compliance .12
5.2 General approach to using standards .13
5.3 Risk management approach to demonstrating compliance .14
5.4 Phases of the medical device life-cycle .14
5.5 Use of standards during medical device life-cycle phases.15
5.5.1 Design and development planning .15
5.5.2 Design and development including testing and validation .15
5.5.3 Regulatory pre-market review .16
5.5.4 Production .16
5.5.5 Post-production including medical device use and post-market surveillance .16
5.5.6 End of life .16
5.6 Assessing the conformity of a medical device .16
6 Essential principles and references to relevant standards and guides .17
6.1 Use of standards by authorities having jurisdiction .17
6.2 Manufacturers’ use of essential principles and references to relevant standards
or guides .17
Annex A (informative) Rationale and guidance .19
Annex B (normative) Table relating essential principles to standards .21
Annex C (informative) Website listings of other standards suitable for the medical device
sector and for assessment purposes.40
Annex D (informative) Reference to the essential principles by International Standards .41
Annex E (informative) Terminology — alphabetized index of defined terms .46
Bibliography .47
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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The 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 cancels 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 non-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
[5]
recommendation , as well as other major jurisdictions (e.g. U.S. FDA regulation the relevant
[6]
aspects of the draft European Medical Device Regulation );
— 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 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 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 and guidance on the selection of standards
iv © ISO 2016 – All rights reserved

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 standards
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 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 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
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 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, 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 part of ISO 16142, 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 reserved

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 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 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 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 adopted for implementation nationally not earlier than three years from
the date of publicatio
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