ISO/TR 14283:2018

Implants for surgery - Essential principles of safety and performance

ISO/TR 14283:2017 provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose. ISO/TR 14283:2017 is often the case that instruments and other equipment are used in association with implants. These devices might be useful or even essential for the safe implantation and/or use of the implants. This document applies to implants, however, it also applies to associated instruments and equipment to the extent that the design and manufacture of the implants is intended to ensure the safe combination and use of the implants with such devices. Requirements for the safe operation and use of associated instruments and equipment are contained in other standards.

Implants chirurgicaux — Principes essentiels de la sécurité et les performances

General Information

• Status: Published
• Publication Date: 02-Jan-2018
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150 - Implants for surgery
• Drafting Committee: ISO/TC 150/WG 7 - Fundamental standards
• Current Stage: 6060 - International Standard published
• Start Date: 03-Jan-2018
• Completion Date: 13-Dec-2025

Relations

• Revises: ISO/TR 14283:2004 - Implants for surgery - Fundamental principles
• Effective Date: 04-Nov-2015

Overview - ISO/TR 14283:2018 (Implants for surgery)

ISO/TR 14283:2018, titled Implants for surgery - Essential principles of safety and performance, is an informative technical report that defines fundamental principles for the design and manufacture of surgical implants. It establishes what manufacturers and stakeholders should consider to ensure implants (active or non‑active) perform as intended and do not compromise patient or user safety. The document supports global regulatory convergence and is intended for use by industry, regulatory authorities and conformity assessment bodies.

Key topics and technical requirements

This technical report outlines the Essential Principles of Safety and Performance and covers a broad set of technical topics, including:

• General design and manufacturing requirements - ensuring implants perform as intended and risks are acceptable when balanced against benefits.
• Chemical, physical and biological properties - biocompatibility and material selection considerations.
• Infection and microbial contamination - controls to reduce infection risks.
• Implants incorporating medicinal substances or biological materials - special considerations where implants include drugs or biologic components.
• Environmental properties - stability and interaction with the biological environment.
• Diagnostic/measurement functions and radiation protection - intended and unintended radiation issues.
• Software and active implants - requirements for implants that incorporate software or use external power.
• Mechanical safety and energy/substance hazards - protection against mechanical failures and risks from supplied energy or substances.
• Labelling and instructions for use (IFU) - required content for labels and IFUs to support safe use.
• Clinical evaluation - use of clinical data to verify safety and performance.

The report also clarifies application to associated instruments and equipment to the extent necessary for safe combination and use, while noting specific operational requirements may be covered in other standards.

Practical applications and users

This technical report is used to:

• Guide medical device and implant manufacturers in product design, risk management and technical documentation.
• Support regulatory authorities and notified bodies when assessing conformity with safety and performance expectations.
• Inform quality managers, clinical engineers, and healthcare procurers about baseline safety principles for implants.
• Help align clinical evaluation and labelling practices across jurisdictions, facilitating market access and patient safety.

Benefits include clearer regulatory alignment, reduced duplication of evidence, and more consistent global approaches to implant safety and performance.

Related standards and guidance

• Derived from Global Harmonisation Task Force (GHTF) guidance and aligned with IMDRF resources.
• Annex A of the report lists corresponding national/regional regulatory requirements.
• Complementary product‑specific ISO/IEC standards (biocompatibility, sterilization, electrical safety, software lifecycle) should be consulted for detailed test methods and requirements.

Keywords: ISO/TR 14283:2018, implants for surgery, essential principles of safety and performance, implant design, medical implants, clinical evaluation, regulatory compliance.

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 14283
Third edition
2018-01
Implants for surgery — Essential
principles of safety and performance
Implants chirurgicaux — Principes essentiels de la sécurité et les
performances
Reference number
©
ISO 2018
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Application of essential principles . 4
5 Essential principles applicable to implants . 4
5.1 General . 4
5.2 Chemical, physical and biological properties . 5
5.3 Infection and microbial contamination . 5
5.4 Implants incorporating a substance considered to be a medicinal product/drug . 6
5.5 Implants incorporating materials of biological origin . 6
5.6 Environmental properties . 7
5.7 Implants with a diagnostic or measuring function . 8
5.8 Protection against radiation . 8
5.8.1 General. 8
5.8.2 Intended radiation . 8
5.8.3 Unintended radiation . 9
5.8.4 Ionizing radiation . 9
5.9 Implants that incorporate software . 9
5.10 Active implants and devices connected to them . 9
5.11 Protection against mechanical risks .10
5.12 Protection against the risks posed to the patient or user by supplied energy
or substances .10
5.13 Label and Instructions for Use .11
5.13.1 General principles .11
5.13.2 Content of the label .12
5.13.3 Content of the instructions for use .13
5.14 Clinical evaluation .15
Annex A (informative) Corresponding regulatory requirements .16
Bibliography .19
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 150, Implants for surgery.
This third edition cancels and replaces the second edition (ISO/TR 14283:2004), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— the previous edition was based on Annex I of the European Council Medical Devices Directive,
while this edition is based on guidance documents developed by the Global Harmonisation Task
Force (GHTF).
iv © ISO 2018 – All rights reserved

Introduction
The purpose of this document is to harmonize the documentation and procedures that are used to assess
whether an implant conforms to the regulations that apply in each jurisdiction. Eliminating differences
between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier
access to new technologies and treatments.
This document has been developed to encourage and support global convergence of regulatory systems.
It is intended for use by regulatory authorities , conformity assessment bodies and industry, and will
provide benefits in establishing, in a consistent way, an economic and effective approach to the control
of implants in the interest of public health. It seeks to strike a balance between the responsibilities of
regulatory authorities to safeguard the health of their citizens and their obligations to avoid placing
unnecessary burdens upon the industry.
A further purpose is to provide a basis for the development of technical standards for implants intended
to have international applicability.
This document describes fundamental design and manufacturing requirements, referred to as
“Essential Principles of Safety and Performance” that, when met, indicate an implant is safe and
performs to its specification.
This document is derived and adapted from the previous version of this document (2004) and from
guidance documents developed by the Global Harmonization Task Force (GHTF) (GHTF/SG 1 documents
[3] [4] [5] [6]
N55, N68, N70 and N71 ). In a few cases additional guidance has been provided and in these
cases the additional guidance has been clearly identified by means of a Note.
This document is, by its nature, purely informative.
Annex A lists applicable pre-existing national or regional requirements, which can be consulted for
comparison with the Essential Principles contained in this report.
The Bibliography provides a list of references that can be used to link these essential principles to
standards and guidance documents giving product related requirements and guidance on the analysis
of risks associated with the use of implants.
NOTE The GHTF documents listed in the Bibliography are subject to periodic review and can be superseded
by later documents. The reader is encouraged to refer to the International Medical Device Regulators Forum
(IMDRF) website at http://www.imdrf.org/documents/documents.asp to confirm whether the referenced
documents remain current.
TECHNICAL REPORT ISO/TR 14283:2018(E)
Implants for surgery — Essential principles of safety and
performance
1 Scope
This document provides fundamental principles for the design and manufacture of active or non-active
implants in order that each implant can achieve its intended purpose.
It is often the case that instruments and other equipment are used in association with implants. These
devices might be useful or even essential for the safe implantation and/or use of the implants. This
document applies to implants, however, it also applies to associated instruments and equipment to the
extent that the design and manufacture of the implants is intended to ensure the safe combination and
use of the implants with such devices.
Requirements for the safe operation and use of associated instruments and equipment are contained in
other standards.
2 Normative references
There are no normative references in this document.
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:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
active implant
implant whose operation depends on a source of electrical energy or any source of power other than
that directly generated by the human body or gravity and which acts by converting this energy
Note 1 to entry: Implants intended to transmit energy, substances or other elements between an active implant
and the patient, without any significant change, are not considered to be active implants.
3.2
clinical data
safety and/or performance information that are generated from the clinical use of a medical device
[SOURCE: GHTF/SG1/N68:2012, 4.0]
3.3
clinical evaluation
assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and
performance of the device when used as intended by the manufacturer
[SOURCE: GHTF/SG1/N68:2012, 4.0]
3.4
clinical investigation
systematic investigation or study in or on one or more human subjects, undertaken to assess the safety
and/or performance of a medical device
[SOURCE: GHTF/SG1/N70:2011, 4.0]
3.5
harm
physical injury or damage to the health of people or damage to property or the environment
[SOURCE: GHTF/SG1/N68:2012, 4.0]
3.6
hazard
potential source of harm
[SOURCE: GHTF/SG1/N68:2012, 4.0]
3.7
implant
medical device which is intended
— to be totally introduced into the human body, or
— to replace an epithelial surface or the surface of the eye
by surgical or clinical intervention, and which is intended to remain in place after the procedure
Note 1 to entry: Any medical device intended to be partially introduced into the human body through surgical or
clinical intervention and intended to remain in place after the procedure for at least 30 days is also considered an
implant.
3.8
information supplied by the manufacturer
see labelling (3.12)
3.9
instructions for use
information provided by the manufacturer to inform the device user of the medical device’s intended
purpose and proper use and of any precautions to be taken
[SOURCE: GHTF/SG1/N70:2011, 4.0]
3.10
intended use
intended purpose
use or purpose for which the implant or medical device is intended as indicated in the product
specifications, instructions and information provided by the manufacturer
[SOURCE: GHTF/SG1/N68:2012, 4.0, modified — "the objective intent of the manufacturer regarding
the use of a product, process or service as reflected in the" has been replaced by "use or purpose for
which the implant or medical device is intended as indicated in the product".]
3.11
label
written, printed, or graphic information either appearing on the medical device itself, or on the
packaging of each unit, or on the packaging of multiple devices
[SOURCE: GHTF/SG1/N70:2011, 4.0]
2 © ISO 2018 – All rights reserved

3.12
labelling
label, instructions for use, and any other information that is related to identification, technical
description, intended purpose and proper use of the medical device, but excluding shipping documents
[SOURCE: GHTF/SG1/N70:2011, 4.0]
3.13
manufacturer
natural or legal person with responsibility for design and/or manufacture of a medical device with the
intention of making the medical device available for use, under his name; whether or not such a medical
device is designed and/or manufactured by that person himself or on his behalf by another person(s)
Note 1 to entry: The term “person” that appears here includes legal entities such as a corporation,
a partnership or an association.
[SOURCE: GHTF/SG1/N055:2009, 5.1, modified.]
3.14
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical 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 by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
[SOURCE: GHTF/SG1/N71:2012, 5.1, modified — A note on products which might be considered to be
medical devices in some jurisdictions but not in others has been deleted.]
3.15
regulatory authority
government agency or other entity that exercises a legal right to control the use or sale of medical
devices within its jurisdiction, and may take enforcement action to ensure that implants marketed
within its jurisdiction comply with legal requirements
[SOURCE: GHTF/SG1/N68:2012, 4.0, modified — the abbreviation “RA” has been deleted.]
3.16
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: GHTF/SG1/N68:2012, 4.0]
4 Application of essential principles
A manufacturer of an implant is expected to design and manufacture a product that is safe and performs
as intended. This document describes fundamental principles for design and manufacturing, referred
to as “Essential Principles of Safety and Performance”, to ensure this outcome.
It is the manufacturer’s responsibility to demonstrate conformity of the implant to all the applicable
essential principles. If for a particular implant some essential principles are considered to be not
applicable, then it is the manufacturer’s responsibility to document the reason for excluding these
essential principles.
5 Essential principles applicable to implants
5.1 General
5.1.1 Implants must be designed and manufactured in such a way that, when used under the conditions
and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience,
education or training, and the medical and physical conditions of intended users, they will perform as
intended by the manufacturer and not compromise the clinical condition or the safety of patients, or
the safety and health of users or, where applicable, other persons, provided that any risks which can be
associated with their use constitute acceptable risks when weighed against the benefits to the patient
and are compatible with a high level of protection of health and safety.
5.1.2 The solutions adopted by the manufacturer for the design and manufacture of the implants must
conform to safety principles, taking account of the generally acknowledged state of the art. When risk
reduction is required, the manufacturer must control the risks so that the residual risk associated with
each hazard is judged acceptable. The manufacturer must apply the following principles in the priority
order listed:
— identify known or foreseeable hazards and estimate the associated risks arising from the intended
use and foreseeable misuse;
— eliminate risks as far as reasonably practicable through inherently safe design and manufacture;
— reduce as far as reasonably practicable the remaining risks by taking adequate protection measures,
including alarms; and
— inform users of any residual risks.
5.1.3 Implants must achieve the performance intended by the manufacturer and be designed and
manufactured in such a way that, during normal conditions of use, they are suitable for their intended
purpose.
5.1.4 The characteristics and performances referred to in 5.1.1, 5.1.2 and 5.1.3 must not be adversely
affected to such a degree that the health or safety of the patient or the user and, where applicable, of
other persons are compromised during the lifetime of the implant, as indicated by the manufacturer,
when the implant is subjected to the stresses which can occur during normal conditions of use and has
been properly maintained in accordance with the manufacturer’s instructions.
5.1.5 Implants must be designed, manufactured and packaged in such a way that their characteristics
and performances during their intended use will not be adversely affected by transport and storage
conditions (for example, fluctuations of temperature and humidity) taking account of the instructions
and information provided by the manufacturer.
4 © ISO 2018 – All rights reserved

5.1.6 All known and foreseeable risks, and any undesirable effects, must be minimised and be
acceptable when weighed against the benefits of the intended performance of implants during normal
conditions of use.
5.2 Chemical, physical and biological properties
5.2.1 The implants must be designed and manufactured in such a way as to ensure the characteristics
and performance referred to in 5.1. Particular attention must be paid to:
— the choice of materials used, particularly as regards toxicity and where applicable flammability,
— the compatibility between the materials used and biological tissues, cells, and body fluids taking
account of the intended purpose of the device,
— the choice of materials used, reflecting, where appropriate, matters such as hardness, wear and
fatigue strength.
NOTE Further information is provided in ISO 10993-1.
5.2.2 The implants must be designed, manufactured and packaged in such a way as to minimize the
risk posed by contaminants and residues to the persons involved in the transport, storage and use of
the implants and to patients, taking account of the intended purpose of the implant. Particular attention
must be paid to tissues exposed and to the duration and frequency of exposure.
5.2.3 The implants must be designed and manufactured in such a way that they can be used safely with
the materials, substances and gases with which they enter into contact during their normal use or during
routine procedures; if the implants are intended to administer medicinal products they must be designed
and manufactured in such a way as to be compatible with the medicinal products concerned according
to the provisions and restrictions governing these products and that their performance is maintained in
accordance with the intended use.
5.2.4 The implants must be designed and manufactured in such a way as to reduce as far as reasonably
practicable and appropriate the risks posed by substances that can leach or leak from the implant. Special
attention must be given to substances which are carcinogenic, mutagenic or toxic to reproduction.
5.2.5 The implants must be designed and manufactured in such a way as to reduce as far as reasonably
practicable and appropriate risks posed by the unintentional ingress or egress of substances into or from
the implant taking into account the implant and the nature of the environment in which it is intended to
be used.
5.2.6 The implants must be designed and manufactured in such a way as to reduce as far as
reasonably practicable and appropriate risks posed by insufficient cleanliness of the implant. Risks
posed by insufficient cleanliness include risks posed by bacterial endotoxins, pyrogens and particulate
contaminates.
NOTE The principle in 5.2.6 has been added to the ones in the previous edition, and to the information given
in Global Harmonization Task Force guidance documents.
5.3 Infection and microbial contamination
5.3.1 The implants and manufacturing processes must be designed in such a way as to eliminate or to
reduce as far as reasonably practicable and appropriate the risk of infection to patients, users and, where
applicable, other persons. The design must:
— allow easy handling, and, where necessary:
— reduce as far as reasonably practicable and appropriate any microbial leakage from the implant
and/or microbial exposure during use,
— prevent microbial contamination of the implant, by the patient, user or other person.
5.3.2 Implants labelled as having a special microbiological state must be designed, manufactured and
packaged to ensure they remain so when placed on the market and remain so under the transport and
storage conditions specified by the manufacturer.
5.3.3 Implants delivered in a sterile state must be designed, manufactured and packaged in a non-
reusable pack, and/or according to appropriate procedures, to ensure that they are sterile when
placed on the market and remain sterile, under the transport and storage conditions indicated by the
manufacturer, until the protective packaging is damaged or opened.
NOTE Further information is provided in ISO 11607.
5.3.4 Implants labelled either as sterile or as having a special microbiological state must have been
processed, manufactured and, if applicable, sterilized by appropriate, validated methods.
NOTE Further information is provided in ISO 11135, ISO 11137, ISO 14937 and ISO 17665.
5.3.5 Implants intended to be sterilized must be manufactured in appropriately controlled (e.g.
environmental) conditions.
NOTE Further information is provided in ISO 14644.
5.3.6 Packaging systems for non-sterile implants must maintain the integrity and cleanliness of the
product and, if the implants are to be sterilized prior to use, minimize the risk of microbial contamination;
the packaging system must be suitable taking account of the method of sterilization indicated by the
manufacturer.
5.3.7 The labelling of the implant must distinguish between identical or similar products placed on the
market in both sterile and non-sterile condition.
5.4 Implants incorporating a substance considered to be a medicinal product/drug
5.4.1 This subclause is not intended to provide guidance on “combination products” as a whole since
definitions have yet to be harmonized and practice varies between different jurisdictions.
5.4.2 Where an implant incorporates, as an integral part, a substance which, if used separately, might
be considered to be a medicinal product/drug as defined in the relevant legislation that applies within
that jurisdiction and which is liable to act upon the body with action ancillary to that of the device, the
safety, quality and performance of the implant as a whole must be verified, as well as the safety, quality
and efficacy of the substance in the specific application.
5.5 Implants incorporating materials of biological origin
5.5.1 This subclause is not intended to provide guidance on “combination products” as a whole since
definitions have yet to be harmonized and practice varies between different jurisdictions.
5.5.2 In some jurisdictions implants incorporating tissues, cells and substances of animal origin might
be considered medical devices. In this case, such tissues, cells and substances should originate from
animals that have been subjected to veterinary controls and surveillance adapted to the intended use of
the tissues. National regulations might require that the manufacturer and/or the Regulatory Authority
retain information on the geographical origin of the animals. Processing, preservation, testing and
6 © ISO 2018 – All rights reserved

handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal
safety for patients, users and, where applicable, other persons. In particular, safety with regard to viruses
and other transmissible agents (e.g. such as prions) must be addressed by implementation of validated
methods of elimination or inactivation in the course of the manufacturing process.
NOTE Further information is provided in ISO 22442 and ISO 14160.
5.5.3 In some jurisdictions implants incorporating human tissues, cells and substances might be
considered medical devices. In this case, the selection of sources, donors and/or substances of human
origin, the processing, preservation, testing and handling of tissues, cells and substances of such origin
must be carried out so as to provide optimal safety for patients, users and, where applicable, other
persons. In particular, safety with regard to viruses and other transmissible agents must be addressed by
implementation of validated methods of elimination or inactivation in the course of the manufacturing
process.
5.5.4 In some jurisdictions implants incorporating cells and substances of microbial origin might
be considered medical devices. In this case, processing, preservation, testing and handling of cells and
substances must be carried out so as to provide optimal safety for patients, users and, where applicable,
other persons. In particular, safety with regard to viruses and other transmissible agents must be
addressed by implementation of validated methods of elimination or inactivation in the course of the
manufacturing process.
5.6 Environmental properties
5.6.1 If the implant is intended for use in combination with other devices or equipment the whole
combination, including the connection system must be safe and must not impair the specified
performance of the implants. Any restrictions on use applying to such combinations must be indicated
on the label and/or in the instructions for use. Connections which the user has to handle, such as fluid,
gas transfer or mechanical coupling, must be designed and constructed in such a way as to minimize all
possible risks from incorrect connection.
5.6.2 Implants must be designed and manufactured in such a way as to remove or reduce as far as
reasonably practicable and appropriate:
5.6.2.1 The risk of injury to the patient, user or other persons in connection with their physical and
ergonomic features;
5.6.2.2 The risk of use error due to the ergonomic features, human factors and the environment in
which the implant is intended to be used;
5.6.2.3 Risks connected with reasonably foreseeable external influences or environmental conditions,
such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation
associated with diagnostic or therapeutic procedures, pressure, humidity, temperature or variations in
pressure and acceleration;
5.6.2.4 The risks associated with the use of the implant when it comes into contact with materials,
liquids, and gases to which it is exposed during normal conditions of use;
5.6.2.5 The risk associated with the possible negative interaction between software and the
environment within which it operates and interacts;
5.6.2.6 The risks of accidental penetration of substances into the implant;
5.6.2.7 The risks of reciprocal interference with other devices normally used in the investigations or
for the treatment given;
5.6.2.8 Risks arising where maintenance or calibration are not possible, including from:
— ageing of materials used,
— loss of accuracy of any measuring or control mechanism,
— excessive increase of leakage currents,
— excess heat generated by the implant.
5.6.3 Implants must be designed and manufactured in such a way as to minimize the risks of fire or
explosion during normal use and in single fault condition. Particular attention must be paid to implants
whose intended use includes exposure to or use in association with flammable substances or substances
which could cause combustion.
5.6.4 Implants must be designed and manufactured in such a way that adjustment, calibration, and
maintenance, where such is necessary to achieve the performances intended, can be done safely.
5.6.5 Implants must be designed and manufactured in such a way as to facilitate the safe disposal of
any waste substances.
5.7 Implants with a diagnostic or measuring function
5.7.1 Diagnostic implants and implants with a measuring function, must be designed and manufactured
in such a way as to provide sufficient accuracy, precision and stability for the intended purpose of the
implant, based on appropriate scientific and technical methods. The limits of accuracy must be indicated
by the manufacturer.
5.7.2 Any measurement, monitoring or display scale used in association with an implant must be
designed in line with ergonomic principles, taking account of the intended purpose of the implant.
5.7.3 Wherever possible values expressed numerically must be in commonly accepted, standardised
units, and understood by the users of the implant.
NOTE There is a possibility that considerations of safety, user familiarity, and established clinical
practice justify the use of recognized measurement units other than those of the internationally standardized
measurement units.
5.8 Protection against radiation
5.8.1 General
Implants must be designed and manufactured and packaged in such a way that exposure of patients,
users and other persons to any emitted radiation must be reduced as far as reasonably practicable and
appropriate, compatible with the intended purpose, while not restricting the application of appropriate
specified levels for therapeutic and diagnostic purposes.
5.8.2 Intended radiation
Where implants are designed to emit hazardous, or potentially hazardous, levels of radiation necessary
for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the
emission, it must be possible for the user to control the emissions. Such implants must be designed and
manufactured to ensure reproducibility of relevant variable parameters within an acceptable tolerance.
8 © ISO 2018 – All rights reserved

5.8.3 Unintended radiation
Implants must be designed and manufactured in such a way that exposure of patients, users and other
persons to the emission of unintended, stray or scattered radiation is reduced as far as reasonably
practicable and appropriate.
5.8.4 Ionizing radiation
5.8.4.1 Implants intended to emit ionizing radiation must be designed and manufactured in such a
way as to ensure that, where reasonably practicable, the quantity, geometry and energy distribution (or
quality) of radiation emitted can be varied and controlled taking into account the intended use.
5.8.4.2 Implants emitting ionizing radiation intended for diagnostic radiology must be designed and
manufactured in such a way as to achieve appropriate image and/or output quality for the intended
medical purpose while minimising radiation exposure of the patient and user.
5.8.4.3 Implants emitting ionizing radiation, intended for therapeutic radiology must be designed and
manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam
type and energy and where appropriate the energy distribution of the radiation beam.
5.9 Implants that incorporate software
5.9.1 Implants incorporating electronic programmable systems, including software must be designed
to ensure repeatability, reliability and performance according to the intended use. In the event of a
single fault condition, appropriate means must be adopted to eliminate or reduce as far as reasonably
practicable and appropriate consequent risks.
5.9.2 For implants which incorporate software, the software must be validated according to the state
of the art taking into account the principles of development lifecycle, risk management, verification and
validation.
5.10 Active implants and devices connected to them
5.10.1 For active implants, in the event of a single fault condition, appropriate means must be adopted
to eliminate or reduce as far as reasonably practicable and appropriate consequent risks.
5.10.2 Implants where the safety of the patients depends on an internal power supply must be equipped
with a means of determining the state of the power supply.
5.10.3 Implants where the safety of the patients depends on an external power supply must include an
electronic alarm system to signal any power failure by way of an external device used in association with
the implant.
5.10.4 Implants intended to monitor one or more clinical parameters of a patient must be equipped
with appropriate electronic alarm systems to alert the user of situations which could lead to death or
severe deterioration of the patient's state of health by way of an external device used in association with
the implant.
5.10.5 Implants must be designed and manufactured in such a way as to reduce as far as reasonably
practicable and appropriate the risks of creating electromagnetic interference which could impair the
operation of this or other devices or equipment in the usual environment.
5.10.6 Implants must be designed and manufactured in such a way as to provide an adequate level of
intrinsic immunity to electromagnetic disturbance to enable them to operate as intended.
5.10.7 Implants must be designed and manufactured in such a way as to avoid, as far as reasonably
practicable, the risk of accidental electric shocks to the patient, user or any other person, both during
normal use of the implant and in the event of a single fault condition in the implant, provided the implant
is installed and maintained as indicated by the manufacturer.
NOTE Further information is provided in ISO 14708 (all parts).
5.11 Protection against mechanical risks
5.11.1 Implants must be designed and manufactured in such a way as to protect the patient and
user against mechanical risks connected with, for example, resistance to movement, instability and
moving parts.
5.11.2 Implants must be designed and manufactured in such a way as to reduce to the lowest practicable
level the risks arising from vibration generated by the implants, taking account of technical progress and
of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the
specified performance.
5.11.3 Implants must be designed and manufactured in such a way as to reduce to the lowest
practicable level the risks arising from the noise emitted, taking account of technical progress and of the
means available to reduce noise, particularly at source, unless the noise emitted is part of the specified
performance.
NOTE The principle in 5.11.3 applies both to audible and electrical noise.
5.11.4 Implants must be designed and manufactured in such a way as to reduce to the lowest practicable
level, the risk of error when certain parts within the implant are intended to be connected or reconnected
before or during use.
5.11.5 Implant (excluding the parts or areas intended to supply heat or reach given temperatures) and
their surroundings must not attain potentially dangerous temperatures under normal conditions of use.
5.11.6 Implant packaging must be designed and manufactured in such a way as to reduce abrasion
between packaging and implant to the lowest practicable level.
NOTE The principle in 5.11.6 has been added to the ones in the previous edition, and to the information
given in Global Harmonization Task Force guidance documents.
5.12 Protection against the risks posed to the patient or user by supplied energy or
substances
5.12.1 Implants for supplying the patient with energy or substances must be designed and constructed
in such a way that the delivered amount can be set and maintained accurately enough to guarantee the
safety of the patient and of the user.
5.12.2 Implants must be fitted with the means of preventing and/or indicating any inadequacies in the
delivered amount which could pose a danger. Implants must incorporate suitable means to prevent, as
far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or
substance source.
5.12.3 The function of the controls and indicators must be clearly specified on the implants or
associated devices. Where an implant or associated device bears instructions required for its operation
or indicates operating or adjustment parameters by means of a visual system, such information must be
understandable to the user.
10 © ISO 2018 – All rights reserved

5.13 Label and Instructions for Use
5.13.1 General principles
This subclause describes the general principles that apply equally to all implants.
— The primary purpose of labelling is to identify the implant and its manufacturer, and communicate
safety and performance related information to the user, professional or other person, as appropriate.
Such information can appear on the implant itself, on packaging or as instructions for use. The
following principles are recommended.
— The medium, format, content, legibility, and location of the label and instructions for use must be
appropriate to the particular device, its intended purpose and the technical knowledge, experience,
education or training of the intended user(s). In particular, instructions for use must be written
in terms readily understood by the intended user and, where appropriate, supplemented with
drawings and diagrams.
— The information required on the label, might be provided on the implant itself. If this is not practicable
or appropriate, some or all of the information can appear on the packaging for each unit, and/or on
the packaging of multiple implants.
— Where the manufacturer supplies multiple implants to a single user and/or location, it might be
sufficient to provide only a single copy of the instructions for use. In these circumstances, the
manufacturer must provide further copies upon request.
— Instructions for use might not be needed or might be abbreviated for implants if they can be used
safely and as intended by the manufacturer without any such instructions for use.
— Labels must be provided in a human-readable format but can be supplemented by machine-readable
forms, such as radio-frequency identification (RFID) or bar codes.
NOTE 1 Further information on a Unique Device Identification (UDI) System for Medical Devices is provided
[1]
in GHTF guidance document GHTF/AHWG-UDI/N2R3 .
— Instructions for use can be provided to the user either in paper or non-paper format (e.g. electronic).
They can be supplied by various means either with the implant or separate from it. Examples of
other means are information downloaded from the manufacturer’s website using the internet,
and machine-readable sources. The means chosen must be appropriate for, and accessible to, the
anticipated user population.
— Where instructions for use are provided on a medium other than paper, the manufacturer must
ensure the user has information on how to:
1) view the instructions for use;
2) access the correct version of the instructions for use; and
3) obtain a paper version of the instructions for use.
NOTE 2 The regulatory authority can set the conditions under which such non-paper format must be provided
to guarantee a high level of protection of health. Those conditions can specify the types of devices that can use a
non-paper format and the requirements the manufacturer needs to respect, such as, that the manufacturer must
upon request provide a paper version of the instructions for use free of charge.
— Residual risks which are required to be comm
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