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• Status: Withdrawn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
• 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 16142-2:2017(E)
©
ISO 2017

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ISO 16142-2:2017(E)

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© ISO 2017, Published in Switzerland
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ISO 16142-2:2017(E)

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
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ISO 16142-2:2017(E)

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.
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ISO 16142-2:2017(E)

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.
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ISO 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 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.
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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 attributes
ISO 3951 (all parts), Sampling procedures for inspection by variables
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137 (all parts), Sterilization of health care products — Radiation
ISO 11138 (all parts), Sterilization of health care products — Biological indicators
ISO 11140 (all parts), Sterilization of health care products — Chemical indicators
ISO 11607 (all parts), Packaging for terminally sterilized medical devices
ISO 11737 (all parts), Sterilization of medical devices — Microbiological methods
ISO/TS 13004, Sterilization of health care products — Radiation — Substantiation of selected sterilization
dose: Method VDmaxSD
ISO 13408 (all parts), Aseptic processing of health care products
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ISO 16142-2:2017(E)

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14161, Sterilization of health care products — Biological indicators — Guidance for the selection, use
and interpretation of results
ISO 14644 (all parts), Cleanrooms and associated controlled environments
ISO 14698 (all parts), Cleanrooms and associated controlled environments — Biocontamination control
ISO 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 devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15193, In vitro diagnostic medical devices — Measurement of quantities in samples of biological
origin — Requirements for content and presentation of reference measurement procedures
ISO 15194, In vitro diagnostic medical devices — Measurement of quantities in samples of biological
origin — Requirements for certified reference materials and the content of supporting documentation
ISO 15195, Laboratory medicine — Requirements for reference measurement laboratories
ISO 15197, In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-
testing in managing diabetes mellitus
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 15882, Sterilization of health care products — Chemical indicators — Guidance for selection, use and
interpretation of results
ISO 16269 (all parts), Statistical interpretation of data
ISO 17511, In vitro diagnostic medical devices — Measurement of quantities in biological samples —
Metrological traceability of values assigned to calibrators and control materials
ISO 17593, Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring
systems for self-testing of oral anticoagulant therapy
ISO 17665 (all parts), Sterilization of health care products — Moist heat
ISO 18113 (all parts), In vitro diagnostic medical devices — Information supplied by the manufacturer
(labelling)
ISO 18153, In vitro diagnostic medical devices — Measurement of quantities in biological samples —
Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control
materials
ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment
ISO 20857, Sterilization of health care products — Dry heat — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives
ISO 23640, In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
ISO/TR 24971, Medical devices — Guidance on the application of ISO 14971
ISO 25424, Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements
for development, validation and routine control of a sterilization process for medical devices
ISO/IEC 15026 (all parts), Systems and software engineering — Systems and software assurance
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ISO 16142-2:2017(E)

ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ISO/IEEE 11073 (all parts), Health informatics — Personal health device communication
1)
CLSI EP05 , Evaluation of precision of quantitative measurement procedures; Approved guideline
1)
CLSI EP06 , Evaluation of the linearity of quantitative measurement procedures: a statistical approach;
Approved guideline
1)
CLSI EP07 , Interference testing in clinical chemistry; Approved guideline
1)
CLSI EP12-A2 , User protocol for evaluation of qualitative test performance; Approved guideline
1)
CLSI EP26-A , User evaluation of between-reagent lot variation; Approved guideline
1)
CLSI POCT12 , Human point-of-care blood glucose testing in acute and chronic care facilities; Approved
guideline
AAMI HE75, Human factors engineering — Design of medical devices
ASTM F2027, Standard guide for characterization and testing of raw or starting biomaterials for tissue-
engineered medical products
ASTM F2761, Medical devices and medical systems — Essential safety requirements for equipment
comprising the patient-centric integrated clinical environment (ICE) — Part 1: General requirements and
conceptual model
EN 13532, General requirements for in vitro diagnostic medical devices for self-testing
EN 13612, Performance evaluation of in vitro diagnostic medical devices
EN 13641, Elimination or reduction of risk of infection related to in vitro diagnostic reagents
EN 14136, Use of external quality assessment schemes in the assessment of the performance of in vitro
diagnostic examination procedures
IEC 60068, Environmental testing
IEC 60812, Analysis techniques for system reliability — Procedure for failure mode and effects analysis (FMEA)
IEC 60825 (all parts), Safety of laser products
IEC 60878, Graphical symbols for electrical equipment in medical practice
IEC 61010-2-101, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-2-6, Electrical equipment for measurement, control and laboratory use — EMC requirements —
Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment
IEC 62304, Medical device software — Software life cycle processes
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 62366-2, Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC 62471, Photobiological safety of lamps and lamp systems
IEC/ISO 80000 (all parts), Quantities and units
IEC/ISO 80001-1, Application of risk management for IT-networks incorporating medical devices — Part 1:
Roles, responsibilities and activities
1) Available from: Clinical and Laboratory Standards Institute, Wayne, PA US.
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ISO 16142-2:2017(E)

IEC/TR 80001-2-1, Application of risk management for IT-networks incorporating medical devices — Part
2-1: Step by step risk management of medical IT-networks — Practical applications and examples
IEC/TR 80001-2-5, Application of risk management for IT-networks incorporating medical devices — Part
2-5: Application guidance — Guidance on distributed alarm systems
IEC/ISO 80002-1, Medical device software — Part 1: Guidance on the application of ISO 14971 to medical
device software
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
Note For convenience, the sources of all defined terms used in this document are given in Annex E.
3.1
authority having jurisdiction
regulatory authority
governmental agency or office assigned to oversee the regulation of a regulated product within a
country, jurisdiction, or assigned territory
3.2
basic standard
standard that includes fundamental concepts or principles and specifies requirements with regard to
general aspects applicable to a wide range of products, processes or services
Note 1 to entry: Basic standards are sometimes referred to as horizontal standards and usually apply to more
than one field (sector).
3.3
essential principles
essential principles of safety and performance
fundamental high-level requirements that when complied with ensure a medical device (3.13) is safe
and performs as intended
3.4
group standard
basic standard (3.2) that specifies safety and performance requirements applicable to several or a
family of similar products, processes or services
Note 1 to entry: Group standards are sometimes referred to as semi-horizontal standards and usually apply to
one field (sector).
3.5
hazard
potential source of harm
[SOURCE: ISO/IEC Guide 51:2014, 3.2]
3.6
hazardous situation
circumstance in which people, property, or the environment is/are exposed to one or more hazards (3.5)
[SOURCE: ISO/IEC Guide 51:2014, 3.4]
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ISO 16142-2:2017(E)

3.7
informative
providing useful or interesting information
Note 1 to entry: Not required for compliance.
3.8
intended use
use for which a product, process or service is intended according to the specifications, instructions and
information provided by the manufacturer (3.12)
[SOURCE: ISO 14971:2007, 2.5]
3.9
IVD kit
IVD medical device kit
set of reactive components that are packaged together and intended to be used to perform a specific
IVD examination
Note 1 to entry: IVD kit components can include reagents (such as antibodies, enzymes, buffer and diluents),
calibrators, controls and other articles and materials.
[SOURCE: ISO 18113-1:2009, 3.32, modified]
3.10
in vitro diagnostic medical device
* IVD medical device
medical device (3.13) intended by the manufacturer (3.12) for the examination of specimens derived
from the human body to provide information for diagnostic, monitoring or compatibility purposes
EXAMPLE Reagents, calibrators, specimen collection and storage devices, control materials and related
instruments, apparatus or articles.
Note 1 to entry: An IVD medical device can be used alone or in combination with accessories or other medical
devices.
[SOURCE: ISO 14971:2007, 2.6, modified]
3.11
life-cycle
all phases in the life of a medical device (3.13), from the initial conception to final decommissioning and
disposal
[SOURCE: ISO 14971:2007, 2.7]
3.12
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging, or labelling of a
medical device (3.13), assembling a system, or adapting a medical device (3.13) before it is placed on the
market or put into service, regardless of whether these operations are carried out by that person or on
that person's behalf by a third party
Note 1 to entry: Attention is drawn to the fact that the provisions of national or regional regulations can apply to
the definition of manufacturer.
Note 2 to entry: For a definition of labelling, see ISO 13485:2016, 3.8.
[SOURCE: ISO 14971:2007, 2.8]
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ISO 16142-2:2017(E)

3.13
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article, intended by the manufacturer (3.12) to be used,
alone or in combination, for human beings for one or more of the specific purpose(s) of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
— investigation, replacement, modification, or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of medical devices,
— providing information for medical purposes by means of in vitro examination of specimens derived
from the human body,
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means.
[5]
Note 1 to entry: This definition has been developed by the Global Harmonization Task Force (GHTF) .
Note 2 to entry: Products, which could be considered to be medical devices in some jurisdictions but for which
there is not yet a harmonized approach, are:
— aids for disabled/handicapped people,
— devices for the treatment/diagnosis of diseases and injuries in animals,
— accessories for medical devices (see Note 3),
— disinfection substances,
— devices incorporating animal and human tissues which can meet the requirements of the above definition
but are subject to different controls.
Note 3 to entry: Accessories intended specifically by manufacturers to be used together with a parent medical
device to enable that medical device to achieve its intended use (3.9) should be subject to this document.
[SOURCE: ISO 14971:2007, 2.9, modified — The word “intended purpose” has been changed to
“intended use”.]
3.14
normative
providing required information
Note 1 to entry: Required for compliance.
3.15
performance evaluation
investigation of a device intended to become an IVD medical device (3.10) for the purpose of establishing
or verifying its performance claims
[SOURCE: ISO 18113-1:2009, 3.52]
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ISO 16142-2:2017(E)

3.16
process standard
standard that specifies requirements for elements of a process used to develop, implement or maintain
a stage of the life-cycle (3.11) of a product or service
Note 1 to entry: A process standard may be a basic standard (3.2), group standard (3.4) or product standard (3.17).
3.17
product standard
standard that specifies necessary safety and performance requirements for a specific or a family of
product(s), process(es), or service(s) making reference, as far as possible, to basic standards (3.2) and
group standards (3.4)
Note 1 to entry: Product standards are sometimes referred to as vertical standards.
3.18
post-production
part of the life-cycle (3.11) of the product after the design has been completed and the medical device
(3.13) has been manufactured
EXAMPLE Transportation, storage, installation, product use, maintenance, repair, product changes,
decommissioning and disposal.
[SOURCE: ISO 14971:2007, 2.11]
3.19
residual risk
risk (3.20)
...