ISO 16142-1:2016
(Main)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
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
ISO 16142:2016, 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 part of ISO 16142 identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic). ISO 16142:2016also 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 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 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. ISO 16142:2016 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.
Dispositifs médicaux — Lignes directrices pour le choix des normes correspondant aux principes essentiels reconnus de sécurité et de performance des dispositifs médicaux — Partie 1: Principes essentiels généraux et principes essentiels spécifiques supplémentaires pour tous les dispositifs médicaux non DIV et directives sur le choix des normes
General Information
Relations
Standards Content (Sample)
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 16142-1:2016(E)
©
ISO 2016
---------------------- Page: 1 ----------------------
ISO 16142-1:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All 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 posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 16142-1:2016(E)
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
© ISO 2016 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 16142-1:2016(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 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
---------------------- Page: 4 ----------------------
ISO 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 standards
© ISO 2016 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 16142-1:2016(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 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
---------------------- Page: 6 ----------------------
ISO 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 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 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 vii
---------------------- Page: 7 ----------------------
INTERNATIONAL STANDARD ISO 16142-1:2016(E)
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
1 Scope
This part of ISO 16142, 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 part of ISO 16142 identifies and 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 considered 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 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 manufacturers, standards
development organizations, authorities having jurisdiction, and conformity assessment bodies.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 1135 (all parts), Transfusion equipment for medical use
ISO 3107, Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
ISO 3826 (all parts), Plastics collapsible containers for human blood and blood components
ISO 5356 (all parts), Anaesthetic and respiratory equipment — Conical connectors
ISO 5359, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
ISO 5360, Anaesthetic vaporizers — Agent-specific filling systems
1)
ISO 5361:— , Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 5362, Anaesthetic reservoir bags
ISO 5364, Anaesthetic and respiratory equipment — Oropharyngeal airways
1) To be published.
© ISO 2016 – All rights reserved 1
---------------------- Page: 8 ----------------------
ISO 16142-1:2016(E)
ISO 5366 (all parts), Anaesthetic and respiratory equipment — Tracheostomy tubes
ISO 5367, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 5832 (all parts), Implants for surgery — Metallic materials
ISO 5834 (all parts), Implants for surgery — Ultra-high-molecular-weight polyethylene
ISO 5838 (all parts), Implants for surgery — Metallic skeletal pins and wires
ISO 5840 (all parts), Cardiovascular implants — Cardiac valve prostheses
ISO 5841 (all parts), Implants for surgery — Cardiac pacemakers
ISO 6474-1, Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high
purity alumina
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 7010, Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 7153-1, Surgical instruments — Metallic materials — Part 1: Stainless steel
ISO 7197, Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components
ISO 7198, Cardiovascular implants — Tubular vascular prostheses
ISO 7199, Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
ISO 7206 (all parts), Implants for surgery — Partial and total hip joint prostheses
ISO 7207 (all parts), Implants for surgery — Components for partial and total knee joint prostheses
ISO 7376, Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation
ISO 7396 (all parts), Medical gas pipeline systems
ISO 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 7494 (all parts), Dentistry — Dental units
ISO 7864, Sterile hypodermic needles for single use
ISO 7886 (all parts), Sterile hypodermic syringes for single use
ISO 8185, Respiratory tract humidifiers for medical use — Particular requirements for respiratory
humidification systems
ISO 8536 (all parts), Infusion equipment for medical use
ISO 8537, Sterile single-use syringes, with or without needle, for insulin
ISO 8637, Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators
ISO 8638, Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters
ISO 8827, Implants for surgery — Staples with parallel legs for orthopaedic use — General requirements
ISO 8828, Implants for surgery — Guidance on care and handling of orthopaedic implants
ISO 8835-7, Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited
logistical supplies of electricity and anaesthetic gases
2 © ISO 2016 – All rights reserved
---------------------- Page: 9 ----------------------
ISO 16142-1:2016(E)
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 9170 (all parts), Terminal units for medical gas pipeline systems
ISO 9360 (all parts), Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gas in humans
ISO 9583, Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic
surgical implants
ISO 9584, Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic
surgical implants
ISO 9626, Stainless steel needle tubing for the manufacturer of medical devices
ISO 9713, Neurosurgical implants — Self-closing intracranial aneurysm clips
ISO 10079 (all parts), Medical suction equipment
ISO 10524 (all parts), Pressure regulators for use with medical gases
ISO 10555 (all parts), Intravascular catheters — Sterile and single-use catheters
ISO 10651 (all parts), Lung ventilators for medical use — Particular requirements for basic safety and
essential performance
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 11040 (all parts), Prefilled syringes
ISO/IEEE 11073 (all parts), Health informatics — Personal health device communication
ISO 11135 (all parts), 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 11197, Medical supply units
ISO 11318, Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions
and test requirements
ISO 11607 (all parts), Packaging for terminally sterilized medical devices
ISO 11608 (all parts), Needle-based injection systems for medical use — Requirements and test methods
ISO 11663, Quality of dialysis fluid for haemodialysis and related therapies
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 13402, Surgical and dental hand instruments — Determination of resistance against autoclaving,
corrosion and thermal exposure
ISO 13408 (all parts), Aseptic processing of health care products
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 13779 (all parts), Implants for surgery — Hydroxyapatite
© ISO 2016 – All rights reserved 3
---------------------- Page: 10 ----------------------
ISO 16142-1:2016(E)
ISO 13782, Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant
applications
ISO 13958, Concentrates for haemodialysis and related therapies
ISO 13959, Water for haemodialysis and related therapies
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical
devices utilizing animal tissues and their derivatives — Requirements for characterization, development,
validation and routine control of a sterilization process for medical devices
ISO 14161, Sterilization of health care products — Biological indicators — Guidance for the selection, use
and interpretation of results
ISO 14242 (all parts), Implants for surgery — Wear of total hip-joint prostheses
ISO 14243 (all parts), Implants for surgery — Wear of total knee-joint prostheses
ISO 14408, Tracheal tubes designed for laser surgery — Requirements for marking and accompanying
information
ISO 14457, Dentistry — Handpieces and motors
ISO 14602, Non-active surgical implants — Implants for osteosynthesis — Particular requirements
ISO 14607, Non-active surgical implants — Mammary implants — Particular requirements
ISO 14630, Non-active surgical implants — General requirements
ISO 14644, Cleanrooms and associated controlled environments
ISO 14698, Cleanrooms and associated controlled environments — Biocontamination control
ISO 14708 (all parts), Implants for surgery — Active implantable medical devices
ISO 14879, Implants for surgery — Total knee-joint prostheses
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/TR 14969, Medical devices — Quality management systems — Guidance on the application of
ISO 13485: 2003
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 15002, Flow-metering devices for connection to terminal units of medical gas pipeline systems
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 15883 (all parts), Washer-disinfectors
ISO 15985, Plastics — Determination of the ultimate anaerobic biodegradation under high-solids anaerobic-
digestion conditions — Method by analysis of released biogas
ISO 16061, Instrumentation for use in association with non-active surgical implants — General requirements
4 © ISO 2016 – All rights reserved
---------------------- Page: 11 ----------------------
ISO 16142-1:2016(E)
ISO 17510, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment
ISO 18777, Transportable liquid oxygen systems for medical use — Particular requirements
ISO 18778, Respiratory equipment — Infant monitors — Particular requirements
ISO 19054, Rail systems for supporting medical 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 21534, Non-active surgical implants — Joint replacement implants — Particular requirements
ISO 21535, Non-active surgical implants — Joint replacement implants — Specific requirements for hip-
joint replacement implants
ISO 21536, Non-active surgical implants — Joint replacement implants — Specific requirements for knee-
joint replacement implants
ISO 21649, Needle-free injectors for medical use — Requirements and test methods
ISO 21969, High-pressure flexible connections for use with medical gas systems
ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives
ISO 22523, External limb prostheses and external orthoses — Requirements and test methods
ISO 22610, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff
and equipment — Test method to determine the resistance to wet bacterial penetration
ISO 22612, Clothing for protection against infectious agents — Test method for resistance to dry microbial
penetration
ISO 22675, Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods
ISO 23328 (all parts), Breathing system filters for anaesthetic and respiratory use
ISO 23500, Guidance for the preparation and quality management of fluids for haemodialysis and related
therapies
ISO 23747, Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of
pulmonary function in spontaneously breathing humans
ISO 23907, Sharps injury protection — Requirements and test methods — Sharps containers
ISO 23908, Sharps injury protection — Requirements and test methods — Sharps protection features for
single-use hypodermic needles, introducers for catheters and needles used for blood sampling
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 25539 (all parts), Cardiovascular implants — Endovascular devices
ISO 26722, Water treatment equipment for haemodialysis applications and related therapies
© ISO 2016 – All rights reserved 5
---------------------- Page: 12 ----------------------
ISO 16142-1:2016(E)
ISO 27186, Active implantable medical devices — Four-pole connector system for implantable cardiac
rhythm management devices - Dimensional and test requirements
ISO 80369 (all parts), Small-bore connectors for liquids and gases in healthcare applications
ISO 81060 (all parts), Non-invasive sphygmomanometers
ISO/IEC 15026 (all parts), Systems and software engineering — Systems and software as
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.