SIST EN ISO 14630:2008
Non-active surgical implants - General requirements (ISO 14630:2008)
Non-active surgical implants - General requirements (ISO 14630:2008)
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dentalimplants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this International Standard gives requirements for intended performance,design attributes, materials, design evaluation, manilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)
Diese Internationale Norm legt allgemeine Anforderungen für nichtaktive chirurgische Implantate fest, im Folgenden Implantate genannt. Diese Norm gilt nicht für Dentalimplantate, dentalrestaurative Werkstoffe, transendodontische und transradikuläre Implantate sowie Intraokularlinsen.
In Bezug auf die Sicherheit legt diese Norm Anforderungen für die beabsichtigte Funktion, Konstruktions¬merkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller sowie Prüfverfahren fest, die erforderlich sind, um die Übereinstimmung mit diesen Anforderungen zu zeigen. Zusätzliche Prüfverfahren sind enthalten in Normen der Level 2 und 3 bzw. es finden sich darin Verweise hierauf.
ANMERKUNG Diese Internationale Norm fordert vom Hersteller kein Qualitätsmanagementsystem. Dennoch könnte die Anwendung eines wie in ISO 13485 beschriebenen Qualitätsmanagementsystems zur Unterstützung der Gewähr¬leistung angemessen sein, dass das Implantat die beabsichtigte Funktion erfüllt.
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2008)
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14630:2008
01-marec-2008
1DGRPHãþD
SIST EN ISO 14630:2005
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2008)
Non-active surgical implants - General requirements (ISO 14630:2008)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2008)
Ta slovenski standard je istoveten z: EN ISO 14630:2008
ICS:
11.040.40
SIST EN ISO 14630:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 14630
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2008
ICS 11.040.40 Supersedes EN ISO 14630:2005
English Version
Non-active surgical implants - General requirements (ISO
14630:2008)
Implants chirurgicaux non actifs - Exigences générales Nichtaktive chirurgische Implantate - Allgemeine
(ISO 14630:2008) Anforderungen (ISO 14630:2008)
This European Standard was approved by CEN on 12 January 2008.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14630:2008: E
worldwide for CEN national Members.
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EN ISO 14630:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC.4
2
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EN ISO 14630:2008 (E)
Foreword
This document (EN ISO 14630:2008) has been prepared by Technical Committee ISO/TC 150 "Implants for
surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat
of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by July 2008, and conflicting national standards shall be withdrawn at the
latest by July 2008.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14630:2005.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 14630:2008 has been approved by CEN as a EN ISO 14630:2008 without any modification.
3
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EN ISO 14630:2008 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
to provide one means of conforming to Essential Requirements of the EU Directive 93/42/EEC of 14 June
1993 concerning medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA 1— Correspondence between this International Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Directive 93/42/EEC Qualifying
this International Standard remarks/Notes
4 1, 2, 3, 4, 5, 7.1
5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2
6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 - 8.2 - 9.2
7 1 - 2 - 3 - 4 - 6 - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 - 14
8 1 - 2 - 3 - 5 - 7.1 - 7.2
9 1 - 2 - 7.2 - 8.1 - 8.3 - 8.4
10 1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6
11 1 - 2 - 8.7 - 13
WARNING — Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
4
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INTERNATIONAL ISO
STANDARD 14630
Third edition
2008-01-15
Non-active surgical implants — General
requirements
Implants chirurgicaux non actifs — Exigences générales
Reference number
ISO 14630:2008(E)
©
ISO 2008
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ISO 14630:2008(E)
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ii © ISO 2008 – All rights reserved
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ISO 14630:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Intended performance .3
5 Design attributes.4
6 Materials .5
7 Design evaluation .5
7.1 General.5
7.2 Pre-clinical evaluation.5
7.3 Clinical evaluation .6
7.4 Post-market surveillance .6
8 Manufacture.6
9 Sterilization.6
9.1 General.6
9.2 Products supplied sterile.6
9.3 Sterilization by the user .7
9.4 Sterilization residuals.7
10 Packaging .7
10.1 Protection from damage in storage and transport.7
10.2 Maintenance of sterility in transit.8
11 Information supplied by the manufacturer .8
11.1 General.8
11.2 Labelling .9
11.3 Instructions for use .9
11.4 Restrictions on combinations .11
11.5 Marking on implants.11
11.6 Marking for special purposes.11
Annex A (informative) Correspondence between this International Standard and
ISO/TR 14283:2004.12
Bibliography .13
© ISO 2008 – All rights reserved iii
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ISO 14630:2008(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.
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 14630 was prepared by Technical Committee ISO/TC 150, Implants for surgery.
This third edition cancels and replaces the second edition (ISO 14630:2005), which has been technically
revised.
iv © ISO 2008 – All rights reserved
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ISO 14630:2008(E)
Introduction
This International Standard provides a method of addressing the fundamental principles outlined in
ISO/TR 14283, as they apply to non-active surgical implants. It also provides a method to demonstrate
compliance with the relevant essential requirements as outlined in general terms in Annex 1 of the European
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as they apply to non-active
surgical implants, hereafter referred to as implants. It might also assist manufacturers to comply with the
requirements of other regulatory bodies.
There are three levels of standards dealing with non-active surgical implants and related instrumentation. For
the implants themselves these are as follows, with level 1 being the highest:
⎯ level 1: general requirements for non-active surgical implants;
⎯ level 2: particular requirements for families of non-active surgical implants;
⎯ level 3: specific requirements for types of non-active surgical implants.
Level 1 standards, such as this International Standard and reference [4] in the Bibliography, contain
requirements that apply to all non-active surgical implants. They also anticipate that there are additional
requirements in the level 2 and level 3 standards.
Level 2 standards (e.g. references [5] – [9] in the Bibliography) apply to a more restricted set or family of non-
active surgical implants, such as those designed for use in neurosurgery, cardiovascular surgery, or joint
replacement.
Level 3 standards (e.g. references [10] – [13] in the Bibliography) apply to specific types of implants within a
family of non-active surgical implants, such as hip joints or arterial stents.
To address all requirements for a specific implant, it is advisable that the standard of the lowest available level
be consulted first.
NOTE The requirements in this International Standard correspond to international consensus. Individual or national
standards or regulatory bodies can prescribe other requirements.
© ISO 2008 – All rights reserved v
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INTERNATIONAL STANDARD ISO 14630:2008(E)
Non-active surgical implants — General requirements
1 Scope
This International Standard specifies general requirements for non-active surgical implants, hereafter referred
to as implants. This International Standard is not applicable to dental implants, dental restorative materials,
transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, this International Standard gives requirements for intended performance, design
attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the
manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or
referred to in level 2 and level 3 standards.
NOTE This International Standard does not require that the manufacturer have a quality management system in
place. However, the application of a quality management system, such as that described in ISO 13485, could be
appropriate to help ensure the implant achieves its intended performance.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 31 (all parts), Quantities and units
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management system
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 13408-1, Aseptic processing of health care products — Part 1: General requirements
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
© ISO 2008 – All rights reserved 1
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ISO 14630:2008(E)
ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin — Validation
and routine control of sterilization by liquid chemical sterilants
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk
management
ISO 22442-2, Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing,
collection and handling
ISO 22442-3, Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the
elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
coating
layer of material covering or partially covering a surface of an implant
3.2
implantable state
condition of an implant prepared for implantation into a human subject
3.3
leakage
unintended movement of fluid, including body fluids, into or out of an implant
NOTE An unintended diffusion phenomenon is an example of leakage for the purposes of this International Standard.
3.4
magnetic resonance environment
MR environment
volume within the 0,50 mT [5 gauss (G)] line of a magnetic resonance imaging (MRI) system, which includes
the entire three-dimensional volume surrounding the magnetic resonance imaging scanner
1)
[ASTM F2503-05 , definition 3.1.7]
NOTE For cases where the 0,50 mT line is contained within the Faraday shielded volume, the entire room is
considered the MR environment. For cases where the 0,50 mT line is outside the Faraday shielded volume (e.g. in the
adjacent room or area), it is advisable that the entire adjacent room or area be considered part of the MR environment.
1) Definitions for magnetic resonance environment and magnetic resonance imaging are reproduced from
ASTM F2503-05 and ASTM F2119-01 respectively, copyright ASTM. Reproduced with permission of ASTM International,
http://www.astm.org/.
2 © ISO 2008 – All rights reserved
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ISO 14630:2008(E)
3.5
magnetic resonance imaging
MRI
diagnostic imaging technique that uses static and time varying magnetic fields to provide images of tissue by
the magnetic resonance of nuclei
1)
[ASTM F2119-01 , definition 2.1.4]
3.6
non-active surgical implant
surgical implant, the operation of which does not depend on a source of electrical energy or any source of
power other than that directly generated by the human body or gravity
3.7
safety
freedom from unacceptable risk
[ISO/IEC Guide 51:1999, definition 3.1]
3.8
surgical implant
device that is intended to be totally introduced into the human body, or to replace an epithelial surface or the
surface of the eye, by means of surgical intervention and that is intended to remain in place after the
procedure, or any medical device that is intended to be partially introduced into the human body by means of
surgical intervention and that is intended to remain in place after the procedure for at least 30 days
4 Intended performance
The intended performance of an implant shall be described and documented by addressing the following, with
particular regard to safety:
a) intended purpose(s);
b) functional characteristics;
c) intended conditions of use;
d) intended lifetime.
NOTE For this purpose, it is advisable that particular account be taken of
⎯ published standards,
⎯ published clinical and scientific literature, and
⎯ validated test results.
© ISO 2008 – All rights reserved 3
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ISO 14630:2008(E)
5 Design attributes
The design attributes to meet the intended performance shall take into account at least the following:
a) materials and their biocompatibility (see Clause 6);
b) physical, mechanical and chemical properties of materials, including endurance properties and ageing
(see Clauses 6 and 7);
c) wear characteristics of materials and the effects of wear and wear products on the implant and the body
(see Clauses 6 and 7);
d) degradation characteristics of materials, and the effects of degradation, degradation products and
leachables on the implant and the body (see Clauses 6 and 7);
e) the extent and effect of leakage (see Clauses 6 and 7);
f) safety with respect to viruses and other transmissible agents (unclassified pathogenic entities, prions and
similar entities), of animal tissues or derivatives of animal tissue utilized in the implant or during its
manufacture (see Clause 6);
g) the effect of manufacturing processes (including sterilization) on material characteristics and performance
(see Clauses 6, 7, 8 and 9);
h) possible effects on the implant and its function due to interactions between its constituent materials and
between its constituent materials and other materials and substances (see Clauses 6 and 7);
i) interconnections and their effects on the intended performance (see Clause 7);
j) interface(s) between the implant and body tissue(s), particularly relative to fixation and connection, and
surface conditions (see Clause 7);
k) shape and dimensions, including their possible effects on tissues and body fluids (see Clause 7);
l) biocompatibility of the implant in its implantable state (see Clauses 6 and 7);
m) physical and chemical effects of the body and external environment on the implant (see Clause 7);
n) effects of radiation, electromagnetic and magnetic fields on the implant and its function, and any
consequential effects on the body (see Clauses 6 and 7);
NOTE Particular attention is drawn to the fields used for magnetic resonance imaging (MRI) in respect of patient
safety. The test methods in ASTM F2052, ASTM F2119, ASTM F2182 and ASTM F2213 can be used to evaluate the
safety of an implant in the MR environment.
o) the ability to implant and, when applicable, to remove or replace the implant (see Clause 7);
p) the ability to visualize the position and orientation of the implant by radiological or other imaging
procedures;
q) microbiological and particulate contamination levels (see Clauses 8, 9 and 10);
r) the suitability and effectiveness of packaging (see Clause 10).
Implant design attributes shall be documented. Where any of the above are not considered to be relevant, the
reason shall be documented and justified.
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ISO 14630:2008(E)
6 Materials
Implant materials shall be selected with regard to the properties required for the intended purpose, also taking
into account the effects of manufacture, handling, sterilization and storage, as well as any treatment
(chemical, electro-chemical, thermal, mechanical, etc.) applied to the surface or a part of the surface of the
implant material in order to modify its properties. Possible reactions of implant materials with human tissues
and body fluids, other materials, other implants, substances and gases shall be considered. Possible effects
of radiation, magnetic and electromagnetic fields on the material shall also be considered.
When a medicinal product is an integral part of an implant, the medicinal product shall be assessed according
to pharmaceutical principles. The performance of the medicinal product used in combination with the implant
shall not be affected by the implant and/or vice versa.
NOTE 1 For the assessment of the safety, quality and usefulness of the medicinal product incorporated as an integral
part of an implant, appropriate methods might be specified in national or regional regulations (e.g. European
Directive 2001/83/EC).
Materials, including biological materials, used for implants and coatings shall be acceptably compatible with
the biological tissues, cells and body fluids with which they are in contact in their implantable state. The
compatibility of possible wear and degradation products shall also be acceptable. The acceptability in the
particular application shall be demonstrated either
a) by documented assessment in accordance with ISO 10993-1, or
b) by selection from the materials found suitable by proven clinical use in similar applications.
NOTE 2 Some of the level 2 standards include lists of materials which have been found acceptable in certain
applications.
For implants utilizing materials of animal origin that are non-viable or have been rendered non-viable either in
the implant or in its manufacture, these materials shall be evaluated and their safety with respect to viruses
and other transmissible agents shall be in accordance with the requirements of ISO 22442-1, ISO 22442-2
and ISO 22442-3.
NOTE 3 See ISO 22442-1 for the definition of the terms “animal” and “tissue”.
7 Design evaluation
7.1 General
Implants shall be evaluated to demonstrate that the intended performance (see Clause 4) is achieved. The
extent to which the intended performance has been achieved shall be determined and documented. Safety
and intended performance shall be demonstrated by pre-clinical evaluation, clinical evaluation and post-
market surveillance, including appropriate risk management at all stages of the life cycle of the implant, in
accordance with the requirements of ISO 14971.
7.2 Pre-clinical evaluation
Implants shall undergo pre-clinical evaluation based on
a) the relevant scientific literature relating to the safety, performance, the design characteristics, and the
intended use of the implant,
b) analysis of available predictive and outcome data from sources such as national and other registries, and
c) analysis of data obtained from testing incl
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