ISO/TR 14283:2004
(Main)Implants for surgery — Fundamental principles
Implants for surgery — Fundamental principles
ISO/TR 14283 provides fundamental principles for the design and manufacture of active or non-active implants in order to achieve the intended purpose.
Implants chirurgicaux — Principes fondamentaux
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Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 14283
Second edition
2004-07-15
Implants for surgery — Fundamental
principles
Implants chirurgicaux — Principes fondamentaux
Reference number
ISO/TR 14283:2004(E)
©
ISO 2004
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ISO/TR 14283:2004(E)
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ISO/TR 14283:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Terms and definitions. 1
3 General principles. 2
4 Specific principles regarding design and construction. 3
4.1 Chemical, physical and biological properties. 3
4.2 Infection and microbial contamination. 4
4.3 Construction and environmental properties. 4
4.4 Implants with a measuring function. 5
4.5 Protection against radiation. 5
4.5.1 General. 5
4.5.2 Intended radiation. 5
4.5.3 Unintended radiation. 5
4.5.4 Instructions. 5
4.6 Ionizing radiation. 6
4.7 Principles for implants connected to or equipped with an energy source. 6
4.7.1 General. 6
4.7.2 Protection against electrical risks. 6
4.7.3 Protection against mechanical risks. 6
4.7.4 Protection against the risks posed to the patient by energy supplies or substances . 7
4.8 Information supplied by the manufacturer. 7
4.9 Clinical evaluation. 9
Annex A (informative) Correspondence to some regulatory documents. 10
A.1 General. 10
A.2 European Economic Area. 10
A.3 Australia. 10
A.4 Canada. 10
A.5 China. 11
A.6 Japan. 11
Bibliography . 15
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ISO/TR 14283:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
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.
ISO/TR 14283 was prepared by Technical Committee ISO/TC 150, Implants for surgery.
This second edition cancels and replaces the first edition (ISO/TR 14283:1995), the annex of which has been
updated.
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ISO/TR 14283:2004(E)
Introduction
Requirements on the design, manufacture and performance of implantable medical devices are developing in
various ways in different countries and international regions. As the medical device industry is already active
on a global basis, and is becoming more so, concern is growing as to the need for international and mutually
recognized standards for the design and performance of such devices.
In order for standards and legal or regulatory requirements to be compatible, they both need to be based on
an understanding of the fundamental principles applicable to the implants. This Technical Report presents a
compilation of these principles. The structure of this report is derived and adapted from the Essential
Requirements given in the European Council Medical Device Directives.
This Technical Report is, by its nature, purely informative.
When balancing risk and benefit to the patients, it is good practice to subject implants to a risk analysis and
this is implicit in this Technical Report. However, risk analysis cannot always identify all risks. Such
uncertainty may be acceptable in the light of perceived benefits to the patient. Follow-up performance review
can provide information to confirm the acceptability of the risk.
The correspondence of the fundamental principles contained in this Technical Report with pre-existing
national and/or regional requirements is contained in Annex A. The bibliography provides a list of standards
that may be used to link these fundamental principles to standards giving product related requirements and
guidance on the analysis of risks associated with the use of implants.
NOTE 1 This report is intended to be a basis for harmonized standards, but it is recognized that specific wording may
be at variance with wording or definitions used in existing national documents, particularly in areas related to “lifetime”,
“intended use”, “normal conditions of use”, etc.
NOTE 2 Should standards based on this Technical Report be recognized by national authorities having responsibility
for approval for commercialization of such devices in their respective countries, the opportunity exists for the
rationalization and harmonization of such approval activities. The consequent overall cost reduction is to the benefit of all
parties, particularly patients, health care providers, insurers and industry.
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TECHNICAL REPORT ISO/TR 14283:2004(E)
Implants for surgery — Fundamental principles
1 Scope
This Technical Report provides fundamental principles for the design and manufacture of active or non-active
implants in order to achieve the intended purpose.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
accessory
article which, while not being a medical device, is intended specifically by its manufacturer to be used together
with a device to enable the device to be used as intended by its manufacturer
2.2
active medical device
any medical device 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 Medical devices intended to transmit energy, substances or other elements between an active medical device
and the patient, without any significant change, are not considered to be active medical devices.
2.3
intended purpose
use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the
instructions and/or in promotional materials
2.4
labelling
all written, printed or graphic matter
affixed to a medical device or any of its containers or wrappers, or
accompanying a medical device
relating to identification, technical description, and use of the medical device, but excluding shipping
documents
NOTE Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer”.
[ISO 13485:2003]
2.5
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device
before it is placed on the market under his/her own name, regardless of whether these operations are carried
out by that person him-/herself or on his/her behalf by a third party
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ISO/TR 14283:2004(E)
2.6
medical device
any instrument, apparatus, appliance, material or other article, whether used alone or in combination,
including the software necessary for its proper application intended by the manufacturer to be used for human
beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
NOTE Adapted from ISO 13485:2003.
2.7
medicinal product
any substance or combination of substances presented for treating or preventing disease in human beings or
animals with a view to making a medical diagnosis, or for restoring, correcting or modifying physiological
functions in human beings or in animals
2.8
surgical implant
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 intervention, and which is intended to remain in place after the procedure
NOTE Any medical device intended to be partially introduced into the human body through surgical intervention and
intended to remain in place after the procedure for at least 30 days is also considered a surgical implant.
3 General principles
3.1 The implants should be designed and manufactured in such a way that, when used under the
conditions and for the purposes intended, they will 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
may 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.
3.2 The solutions adopted by the manufacturer for the design and construction of the implants should
conform to safety principles, taking into account the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer should apply the following principles in the
following order:
a) eliminate or reduce risks as far as possible (inherently safe design and construction);
b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks
that cannot be eliminated;
c) inform users of the residual risks due to any shortcomings of the protection measures adopted.
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3.3 The implants should achieve the performance intended by the manufacturer and be designed,
manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in
3.1, as specified by the manufacturer.
3.4 When the implant is subjected to stresses which can occur during normal conditions of use, the
characteristics and performances referred to in 3.1, 3.2 and 3.3 should not be adversely affected to such a
degree that the clinical conditions and safety of the patients and, where applicable, of other persons are
compromised during the lifetime of the implant as indicated by the manufacturer.
3.5 The implants should be designed, manufactured and packed in such a way that their characteristics and
performances during their intended use will not be adversely affected during transport and storage when
taking into account the instructions and information provided by the manufacturer.
3.6 Any undesirable side-effect should constitute an acceptable risk when weighed against the
performances intended.
4 Specific principles regarding design and construction
4.1 Chemical, physical and biological properties
4.1.1 The implants should be designed and manufactured in such a way as to guarantee the characteristics
and performances referred to in Clause 3 on general principles. Particular attention should be paid to
a) the choice of materials used, particularly as regards toxicity and, where appropriate, flammability,
b) the compatibility between the materials used and biological tissues, cells and body fluids, taking into
account the intended purpose of the implant.
4.1.2 The implants should be designed, manufactured and packed 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 the patients, taking into account the intended purpose of the product. Particular attention should be
paid to the tissues exposed and to the duration and frequency of exposure.
4.1.3 The implants should 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 should 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 such that their performance is maintained in
accordance with the intended use.
4.1.4 If an implant incorporates, as an integral part, a substance which, if used separately, may be
considered to be a medicinal product as defined in 2.7 and which is liable to act upon the body with action
ancillary to that of the implant, the safety, quality and usefulness of the substance should be verified, taking
into account the intended purpose of the implant.
4.1.5 The implants should be designed and manufactured in such a way as to reduce to a minimum the
risks posed by substances leaking from the implant.
4.1.6 Implants should be designed and manufactured in such a way as to reduce, as much as possible,
risks posed by the unintentional ingress of substances into the implant, taking into account the implant and the
nature of the environment in which it is intended to be used.
4.1.7 Implants should be designed and manufactured in such a way as to minimize the risks to the patient
or user by the programming and control systems, including software.
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4.2 Infection and microbial contamination
4.2.1 The implants and manufacturing processes should be designed in such a way as to eliminate or
reduce as far as possible the risk of infection to the patient, user and third parties. The design should allow
easy handling and, where necessary, minimize contamination of the implant by the patient, or vice versa,
during use.
4.2.2 Tissues of animal origin should originate from animals that have been subjected to veterinary controls
and surveillance adapted to the intended use of the tissues.
Information on the geographical origin of the animals should be retained by the manufacturer.
Processing, preservation, testing and handling of tissues, cells and substances of animal origin should be
carried out so as to provide optimal security. In particular, safety with regard to viruses and other transferable
agents should be addressed by implementation of validated methods of elimination or viral inactivation in the
course of the manufacturing process.
4.2.3 Implants delivered in a sterile state should be designed, manufactured and packed in protective
packaging which provides a microbial barrier to ensure that they are sterile when placed on the market and
remain sterile, under the storage and transport conditions stipulated by the manufacturer, until the protective
packaging is damaged or opened.
4.2.4 Implants delivered in a sterile state should have been manufactured and sterilized by an appropriate,
validated method.
4.2.5 Implants intended to be sterilized should be manufactured in appropriately controlled (e.g.
environmental) conditions.
4.2.6 Packaging systems for non-sterile implants should keep the product without deterioration at the level
of cleanliness stipulated and, if the implants are to be sterilized prior to use, minimize the risk of microbial
contamination. The packaging system should be suitable, taking into account the method of sterilization
indicated by the manufacturer.
4.2.7 The packaging and/or label of the implant should distinguish between identical or similar products sold
in both sterile and non-sterile conditions.
4.3 Construction and environmental properties
4.3.1 If the implant is intended for use in combination with other devices or equipment, the whole
combination, including the connection system, should be safe and should not impair the specified
performances of the devices. Any restrictions on use should be indicated on the label or in the instructions for
use.
4.3.2 Implants should be designed and manufactured in such a way as to remove or minimize, as far as
possible, the following:
a) risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional
and where appropriate ergonomic features,
b) risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external
electrical influences, electrostatic discharge, pressure, temperature or variations in pressure and
acceleration,
c) risks of reciprocal interference with other devices (such as defibrillators or high-frequency surgical
equipment) normally used in the investigations or for the treatment given,
d) risks which may arise where maintenance and calibration are impossible, including (if applicable)
excessive increase of leakage currents,
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ageing of materials used,
excess heat generated by the implant,
decreased accuracy of any measuring or control mechanism.
4.3.3 Implants should be designed and manufactured in such a way as to minimize the risks of fire or
explosion during normal conditions and fault conditions. By “risks during normal conditions and fault
conditions” are meant those risks which have been determined by a risk analysis. Particular attention should
be paid to implants whose intended use includes exposure to flammable substances or to substances which
could cause combustion.
4.4 Implants with a measuring function
4.4.1 Implants with a measuring function should be designed and manufactured in such a way as to provide
sufficient accuracy and stability, within appropriate limits of accuracy and taking into account the intended
purpose of the implant. The limits of accuracy should be indicated by the manufacturer.
4.4.1.1 The measurements, monitoring and display scale should be designed in accordance with
ergonomic principles, taking into account the intended purpose of the implant.
4.4.1.2 If an implant or its accessories bears instructions required for the operation of the implant or
indicates operating or adjustment parameters by means of a visual system, such information must be
understandable to the user and, as appropriate, the patient.
4.4.2 The measurements made by implants with a measuring function should be expressed in units
conforming to the provisions of the ISO 31 series.
4.5 Protection against radiation
4.5.1 General
Implants should be designed and manufactured in such a way that exposure of patients, users and other
persons to radiation is reduced as low as possible, compatible with the intended purpose, while not restricting
the application of appropriate specified levels for therapeutic and diagnostic purposes.
4.5.2 Intended radiation
4.5.2.1 If implants are designed to emit hazardous levels of radiation necessary for a specific medical
purpose, the benefit of which is considered to outweigh the risks inherent in the emission, the implants should
be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters.
4.5.2.2 If implants are intended to emit potentially hazardous, visible and/or invisible radiation, they
should be fitted, where practicable, with visual displays and/or audible warnings of such emissions.
4.5.3 Unintended radiation
Implants should 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 possible.
4.5.4 Instructions
The operating instructions for implants emitting radiation should give detailed information as to the nature of
the emitted radiation, means of protecting the patient and the user, and ways to avoid misuse and eliminate
the risks inherent in use.
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ISO/TR 14283:2004(E)
4.6 Ionizing radiation
4.6.1 Implants intended to emit ionizing radiation should be designed and manufactured in such a way as to
ensure that, where practicable, the quantity, geometry and quality of radiation emitted can be varied and
controlled taking into account the intended use.
4.6.2 Implants emitting ionizing radiation intended for diagnostic radiology should be designed and
manufactured in such a way as to achieve appropriate image and/or output quality for the intended medical
purpose while minimizing radiation exposure of the patient and user.
4.6.3 Implants emitting ionizing radiation, intended for therapeutic radiology should be designed and
manufactured in such a way as to enable reliable monitoring and control of the delivered dose.
4.7 Principles for implants connected to or equipped with an energy source
4.7.1 General
4.7.1.1 Implants incorporating electronic programmable systems should be designed to ensure the
repeatability, reliability and performance of these systems according to their intended use. In the event of risks
(of the system) as determined by a risk analysis for the particular device/system, appropriate means should be
adopted to eliminate or reduce as far as possible their risk.
4.7.1.2 Implants for which the safety of the patients depends on an internal power supply should be
equipped with a means of determining the state of the power supply.
4.7.1.3 Implants should bear, if practical and appropriate, a code by which they and their manufacturer
can be unequivocally identified (particularly with regard to the type of implant). It should be possible to read
this code, if necessary, without the need for a surgical operation.
4.7.1.4 For implants for which the safety of the patients depends on an external power supply, the
external power supply should include an alarm system to signal any power failure.
4.7.1.5 External devices intended to monitor one or more clinical parameters from an implant should be
equipped with appropriate alarm systems to alert the user to situations which could lead to death or severe
deterioration of the patient's state of health.
4.7.2 Protection against electrical risks
4.7.2.1 Implants should be designed and manufactured in such a way as to avoid, as far as possible, the
risk of accidental electric shocks during normal conditions and fault conditions provided the implants are
installed correctly. By the “risks during normal conditions and fault conditions” are meant those risks which
have been determined by a risk analysis for the particular device(s).
4.7.2.2 Active implants should be designed and manufactured in such a way as to minimize the risks
connected with the use of energy sources, with particular reference, where electricity is used, to insulation,
leakage currents and overheating of the devices.
4.7.3 Protection against mechanical risks
4.7.3.1 Implants should be designed and manufactured in such a way as to protect the patient and user
against mechanical risks, for example those connected with resistance, stability and moving parts.
4.7.3.2 Implants should be designed and manufactured in such a way as to minimize the risks arising
from vibration generated by the implants, taking into account technical progress and the means available for
limiting vibration, particularly at source, unless the vibrations are part of the specified performance.
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4.7.3.3 Implants should be designed and manufactured in such a way as to minimize the risks arising
from the noise emitted, taking into account technical progress and the means available to reduce noise,
particularly at source, unless the noise emitted is part of the specified performance.
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