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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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
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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
...
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