SIST EN ISO 14630:2013

SLOVENSKI STANDARD
SIST EN ISO 14630:2013
01-marec-2013
1DGRPHãþD
SIST EN ISO 14630:2009
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2012)
Non-active surgical implants - General requirements (ISO 14630:2012)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2012)
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2012)
Ta slovenski standard je istoveten z: EN ISO 14630:2012
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14630:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14630:2013

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SIST EN ISO 14630:2013


EUROPEAN STANDARD
EN ISO 14630

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2012
ICS 11.040.40 Supersedes EN ISO 14630:2009
English Version
Non-active surgical implants - General requirements (ISO
14630:2012)
Implants chirurgicaux non actifs - Exigences générales Nichtaktive chirurgische Implantate - Allgemeine
(ISO 14630:2012) Anforderungen (ISO 14630:2012)
This European Standard was approved by CEN on 30 November 2012.

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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14630:2012: E
worldwide for CEN national Members.

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SIST EN ISO 14630:2013
EN ISO 14630:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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SIST EN ISO 14630:2013
EN ISO 14630:2012 (E)
Foreword
This document (EN ISO 14630:2012) 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 June 2013, and conflicting national standards shall be withdrawn at
the latest by June 2013.
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 14630:2009.
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 EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14630:2012 has been approved by CEN as a EN ISO 14630:2012 without any modification.
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SIST EN ISO 14630:2013
EN ISO 14630:2012 (E)
Annex ZA
(informative)

Relationship between this European Standard and
the Essential Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union 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 European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 93/42/EEC
4 1, 2nd indent
4, 5, 8 and 10 5
7.1 and 7.2 6a
5 a), 5 l), 6 a) and 6 b) 7.1, 1st indent
5 a), 6 a) and 6 b) 7.1, 2nd indent
7.2 c) 7.1, 3rd indent
5 f), 5 r), 7, 8 and 10 7.2
5 h) and 6 7.3
6 7.4
5 d), 5 e) and 6 7.5
5 b), 5 f), 5 m) and 6 7.6
5 q), 6, 8, 9.1 and 10.1 8.1
6 8.2
10.2 8.3
9.2 8.4
5 g), 8 and 9.3 8.5
9.1 and 10.1 8.6
11.2 f) and 11.3 j) 8.7
5 i), 5 j) and 11.4 9.1
5 b), 5 k), 6 and 7.1 9.2, 1st indent
5 n), 6 and 7.1 9.2, 2nd indent
5 n) 9.2, 3rd indent
5 c), 5 d) and 6 9.2, 4th indent
11.1, 11.2, 11.3 b), g), h) and 11.5 13.1
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SIST EN ISO 14630:2013
EN ISO 14630:2012 (E)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 93/42/EEC
11.1 13.2
11.2 b) 13.3 a)
11.2 c) and 11.2 d) 13.3 b)
11.2 e) 13.3 c)
11.2 c) 13.3 d)
11.2 g) 13.3 e)
11.2 h) 13.3 f)
11.6 13.3 g)
11.6 13.3 h)
10.1 and 11.2 j) 13.3 i)
11.2 j) 13.3 j)
11.2 k) 13.3 k)
11.2 e) 13.3 m)
11.2 d) and 11.3 d) 13.4
4 and 11.2 c) 13.5
11.3 b), c), d), i), m), n) and 11.6 13.6 a)
11.3 e) 13.6 b)
11.3 f) and 11.4 13.6 c)
11.3 h) 13.3 d)
11.3 g) and o) 13.6 e)
11.3 q), r) and t), Indent 5 13.6 f)
9.3.2, 10.2 and 11.3 l) 13.6 g)
9.3 and 11.2 k) 13.6 i)
11.3 a) 13.6 j)
11.3 b) and t), Indent 3 13.6 k)
11.3 t), Indents 1, 2 and 4 13.6 l)
11.3 t), Indent 6 13.6 m)
11.3 s) 13.6 n)
11.3 u) 13.6 q)

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

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SIST EN ISO 14630:2013

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SIST EN ISO 14630:2013
INTERNATIONAL ISO
STANDARD 14630
Fourth edition
2012-12-01
Non-active surgical implants — General
requirements
Implants chirurgicaux non actifs — Exigences générales
Reference number
ISO 14630:2012(E)
©
ISO 2012

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SIST EN ISO 14630:2013
ISO 14630:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 14630:2013
ISO 14630:2012(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 . 3
6 Materials . 4
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 . 7
11 Information supplied by the manufacturer . 8
11.1 General . 8
11.2 Labelling . 8
11.3 Instructions for use . 9
11.4 Restrictions on combinations .10
11.5 Marking on implants .10
11.6 Marking for special purposes . 11
Bibliography .12
© ISO 2012 – All rights reserved iii

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SIST EN ISO 14630:2013
ISO 14630:2012(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 fourth edition cancels and replaces the third edition (ISO 14630:2008), which has been technically revised.
iv © ISO 2012 – All rights reserved

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SIST EN ISO 14630:2013
ISO 14630:2012(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 for demonstrating
compliance with the relevant essential requirements as outlined in the 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 help manufacturers 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, they 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], 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 (see References [5], [6], [7], [8] and [9]) 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 (see References [10], [11], [12] and [13]) 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 2012 – All rights reserved v

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SIST EN ISO 14630:2013

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SIST EN ISO 14630:2013
INTERNATIONAL STANDARD ISO 14630:2012(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 specifies 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, might be appropriate to
help ensure that 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 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 process
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, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical
devices utilizing animal tissues and their derivatives — Requirements for characterization, development,
validation and routine control of a sterilization process for medical devices
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 2012 – All rights reserved 1

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SIST EN ISO 14630:2013
ISO 14630:2012(E)
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
ISO 80000 (all parts), Quantities and units
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 1 to entry: 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
NOTE 1 to entry: 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.
[SOURCE: ASTM F2503-05, 3.1.7, modified — the second sentence has been converted into a note.]
3.5
magnetic resonance imaging
MRI
imaging technique that uses static and time varying magnetic fields to provide images of tissue by the magnetic
resonance of nuclei
[SOURCE: ASTM F2119-07, 2.1.4]
3.6
non-active surgical implant
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
[SOURCE: ISO/IEC Guide 51:1999, 3.1]
2 © ISO 2012 – All rights reserved

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SIST EN ISO 14630:2013
ISO 14630:2012(E)
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 To describe the intended performance, it is advisable that particular account be taken of the following, among
other things:
— published standards,
— published clinical and scientific literature, and
— validated test results.
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);
NOTE It is advisable that the shape, dimensions and tolerances of the interconnections, as well as the potential
wear, degradation, corrosion and electrolytic effects, be taken into account.
© ISO 2012 – All rights reserved 3

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SIST EN ISO 14630:2013
ISO 14630:2012(E)
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, where 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);
s) where appropriate, the anthropometric and anatomical features of the population for whom the implant is
intended;
t) the condition and pathology of the host tissue;
u) required operative techniques and the appropriate care and handling of the implant to reduce the risk of
use error while not impairing the intended use and performance of the implant;
v) where applicable, the nature and type of any radioactive substances incorporated in or used with the
implant to achieve the intended performance while reducing or eliminating the risk of exposure of patients,
users and other persons to unintended radiation.
Implant design attributes shall be documented. Where any of the above are not considered to be relevant, the
reason shall be documented and justified.
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
and of 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 compatible to an acceptable
degree 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
...