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I.S. EN 12564:1999

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS

Available format(s)

Hardcopy , PDF

Superseded date

12-10-2007

Superseded by

I.S. EN ISO 21536:2007

Language(s)

English

Published date

01-01-1999

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacture
9 Sterilization
10 Packaging
11 Information to be supplied by the manufacturer
Annex A (normative) Evaluation of range of relative
        angular motion of components of fully
        constrained total knee joint replacement
        implants
Annex B (normative) Bibliography
Annex ZA (informative) Clauses of this European
         Standard addressing essential requirements or
         other provisions of EU Directives

Defines specific requirements for knee joint replacement implants. Conforming to safety, gives requirements for intended performance, manufacture, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer and methods of test.

DocumentType
Standard
Pages
12
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
NF EN 12564 : 1999 Identical
NS EN 12564 : 1ED 1998 Identical
SN EN 12564 : 1999 Identical
EN 12564 : 1998 Identical
NEN EN 12564 : 1999 Identical
DIN EN 12564:1999-02 Identical
NBN EN 12564 : 1999 Identical
UNE-EN 12564:1999 Identical
BS EN 12564:1999 Identical
UNI EN 12564 : 2000 Identical

EN 12010 : 1998 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
ISO 14879-1:2000 Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial trays
ISO 7207-1:2007 Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions
ISO 14243-1:2009 Implants for surgery — Wear of total knee-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
ISO 14243-2:2016 Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)

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