ISO/TR 14283:2018
(Main)Implants for surgery — Essential principles of safety and performance
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
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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/TR 14283:2018(E)
©
ISO 2018
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ISO/TR 14283:2018(E)
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ISO/TR 14283:2018(E)
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
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ISO/TR 14283:2018(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 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).
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ISO/TR 14283:2018(E)
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.
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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]
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ISO/TR 14283:2018(E)
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]
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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]
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ISO/TR 14283:2018(E)
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.
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ISO/TR 14283:2018(E)
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:
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ISO/TR 14283:2018(E)
— 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
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ISO/TR 14283:2018(E)
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 ce
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