I.S. EN 12006-1:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - HEART VALVE SUBSTITUTES
Hardcopy , PDF
03-10-2006
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (normative) Classification of valves
Annex B (informative) Physical and material properties
of heart valve substitutes and
their components
Annex C (informative) Standards that may be applicable
for testing materials and
components of heart valve
substitutes
Annex D (informative) Test apparatus for mechanical
testing
Annex E (normative) Test apparatus for hydrodynamic
testing
Annex F (informative) Rationales for pre-clinical: and
clinical evaluations
Annex G (informative) Concordance table EN 12006-1 and
ISO 5840
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements
or other provisions of
EU Directives
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