EN ISO 14630:2005
(Main)Non-active surgical implants - General requirements (ISO 14630:2005)
Non-active surgical implants - General requirements (ISO 14630:2005)
This European Standard specifies general requirements for non-active surgical implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests. Tests required to be used to demonstrate compliance with this standard are contained in other levels.
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2005)
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, Konstruktionsmerkmale, 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 in anderen Ebenen enthalten bzw. es finden sich Verweise in anderen Ebenen auf diese.
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2005)
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2005
1DGRPHãþD
SIST EN ISO 14630:2000
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2005)
Non-active surgical implants - General requirements (ISO 14630:2005)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2005)
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2005)
Ta slovenski standard je istoveten z: EN ISO 14630:2005
ICS:
11.040.40
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 14630
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2005
ICS 11.040.40 Supersedes EN ISO 14630:1997
English version
Non-active surgical implants - General requirements (ISO
14630:2005)
Implants chirurgicaux non actifs - Exigences générales Nichtaktive chirurgische Implantate - Allgemeine
(ISO 14630:2005) Anforderungen (ISO 14630:2005)
This European Standard was approved by CEN on 22 April 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14630:2005: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 14630:2005) 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 NEN.
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 November 2005, and conflicting national
standards shall be withdrawn at the latest by November 2005.
This document supersedes EN ISO 14630:1997.
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 organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 14630:2005 has been approved by CEN as EN ISO 14630:2005 without any
modifications.
ANNEX ZA
(informative)
Relationship between this International 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 New
Approach 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 normative 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 relevant Essential
Requirements of that Directive and associated EFTA regulations.
Table ZA.1— Correspondence between this International Standard and Directive
93/42/EEC
Clause/subclause of this Essential requirements (ERs) of EU Qualifying
International Standard Directive 93/42/EEC remarks/Notes
1- 2 - 4 - 7.1
1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 - 7.5
- 7.6 - 8 - 9.1 - 9.2
1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 - 8.2
- 9.2
1 - 2 - 3 - 4 - 6 - 7.1 - 7.2 - 7.3 - 7.5
- 7.6 - 8 - 9.1 - 9.2 - 14
1 - 2 - 3 - 5 - 7.1 - 7.2
1 - 2 - 7.2 - 8.1 - 8.3 - 8.4
1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6
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.
INTERNATIONAL ISO
STANDARD 14630
Second edition
2005-05-01
Non-active surgical implants — General
requirements
Implants chirurgicaux non actifs — Exigences générales
Reference number
ISO 14630:2005(E)
©
ISO 2005
ISO 14630:2005(E)
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ii © ISO 2005 – All rights reserved
ISO 14630:2005(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. 5
7.4 Post market surveillance. 5
8 Manufacture. 5
9 Sterilization. 5
9.1 General. 5
9.2 Products supplied sterile . 6
9.3 Sterilization by the user. 6
9.4 Sterilization residuals . 6
10 Packaging . 6
10.1 Protection from damage in storage and transport . 6
10.2 Maintenance of sterility in transit. 7
11 Information supplied by the manufacturer. 7
11.1 General. 7
11.2 Labelling. 7
11.3 Instructions for use. 8
11.4 Restrictions on combinations. 9
11.5 Marking on implants . 9
11.6 Marking for special purposes . 10
Annex A (informative) Correspondence of the clauses of this International Standard to the
fundamental principles as outlined in ISO/TR 14283:2004 . 11
Bibliography . 12
ISO 14630:2005(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 second edition cancels and replaces the first edition (ISO 14630:1997), which has been technically
revised.
For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council
Directives has been removed.
iv © ISO 2005 – All rights reserved
ISO 14630:2005(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
Community 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 may 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 i
...
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