BS EN ISO 14602:2010 - Non-active surgical implants. Implants for osteosynthesis. Particular requirements – BSI British Standards

BS EN ISO 14602:2010

Non-active surgical implants. Implants for osteosynthesis. Particular requirements

Status : Revised, Withdrawn   Published : May 2010 Replaced By : BS EN ISO 14602:2011

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BS EN ISO 14602:2010 Non-active surgical implants. Implants for osteosynthesis. Particular requirements

BS EN ISO 14602 is an International Standard which specifies particular requirements for non-active surgical implants for osteosynthesis.

In addition to BS EN ISO 14630, BS EN ISO 14602 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

Contents of BS EN ISO 14602:

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
4.1 General
4.2 Intended purpose
4.3 Functional characteristics
4.4 Intended conditions of use
5 Design attributes
6 Materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.3 Clinical evaluation
7.4 Post-market surveillance
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by manufacturer
11.1 General
11.2 Labelling
11.3 Instructions for use
11.4 Restrictions on combinations
11.5 Marking on implant
11.6 Marking for special purposes
Annex A (informative) Correspondence of the clauses of this International Standard to the fundamental principles outlined in ISO/TR 14283
Annex B (informative) ISO standards referring to implants and associated instruments found acceptable through clinical use for given applications in osteosynthesis
Annex C (informative) ISO Standards referring to materials found acceptable through proven clinical use
Annex D (informative) Standards related to testing and design evaluation
Bibliography

 




Standard NumberBS EN ISO 14602:2010
TitleNon-active surgical implants. Implants for osteosynthesis. Particular requirements
StatusRevised, Withdrawn
Publication Date31 May 2010
Confirm Date22 September 2015
Withdrawn Date31 October 2011
Normative References(Required to achieve compliance to this standard)ISO 14630:2008
Informative References(Provided for Information)ISO 15814, ISO 15142-2, ISO 5834-3, ISO 9714-1, ISO 15142-3, ISO 13782, ISO 5834-4, ISO 16429, ISO 10334, ISO 6474-2, ISO 9584, ISO 15142-1, ISO 5832-9, ISO 5833, ISO 9585, ISO 13779-1, ISO 5832-14, ISO 8319-1, ISO 5835, ISO 13356, ISO 5832-12, ISO 8615, ISO 16402, ISO 6475, ISO 9268, ISO 16428, ISO 5836, ISO 5832-8, ISO 5834-5, ISO 5838-3, ISO 9269, ISO 8828, ISO 14949, ISO 5832-1, ISO 5832-4, ISO 5834-1, ISO 13779-2, ISO 5838-1, ISO 5832-3, ISO/TR 9586, ISO 13779-4, ISO 5832-5, ISO 5834-2, ISO 5837-2, ISO 5832-6, ISO 5832-7, ISO 6474-1, ISO/TR 14283:2004, ISO 5837-1, ISO 8319-2, 2007/47/EC, 93/42/EEC, ISO 5838-2, ISO 15374, ISO 20160, ISO 9583, ISO 23317, ISO 5832-11, ISO 13779-3, ISO 5832-2
Replaced ByBS EN ISO 14602:2011
ReplacesBS EN ISO 14602:2009
International RelationshipsEN ISO 14602 (ISO 14602:2010),ISO 14602:2010
Draft Superseded By09/30198885 DC
DescriptorsDesign, Instructions for use, Medical equipment, Surgical equipment, Implants (surgical), Orthopaedics, Performance testing, Performance, Orthopaedic equipment
ICS11.040.40
Title in FrenchImplants chirurgicaux non actifs. Implants pour ostéosynthèse. Exigences particulières
Title in GermanNichtaktive chirurgische Implantate. Implantate zur Osteosynthese. Besondere Anforderungen
CommitteeCH/150/5
ISBN978 0 580 66818 0
PublisherBSI
FormatA4
DeliveryNo
Pages24
File Size468 KB
Price£182.00


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