I.S. EN 12564:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
10-12-2007
English
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.
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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Superseded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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