BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Non-active surgical implants. Particular requirements for cardiac and vascular implants Heart valve substitutes
Hardcopy , PDF
29-12-2006
English
15-11-1999
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
Defines requirements for heart valve substitutes, excluding heart valve substitutes composed in whole, or in part, of human tissue. Supplied with consideration to safety, requirements for intended design attributes, performance, design evaluation, materials, manufacturing, sterilization, packaging and information supplied by the manufacturer. Defines a number of requirements and test procedures with respect to performance characteristics of equipment which is used to determine the chemical, biological and physical properties of heart valve substitutes and of materials and components from which they are made.
Committee |
CH/150/2
|
DevelopmentNote |
To be read in conjunction with BS EN ISO 14630. Supersedes 95/562277 DC (08/2004)
|
DocumentType |
Standard
|
Pages |
52
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
NBN EN 12006-1 : 1999 | Identical |
I.S. EN 12006-1:1999 | Identical |
NF EN 12006-1 : 1999 | Identical |
DIN EN 12006-1:1999-10 | Identical |
NEN EN 12006-1 : 1999 | Identical |
NS EN 12006-1 : 1ED 1999 | Identical |
SN EN 12006-1 : 1999 | Identical |
UNE-EN 12006-1:2000 | Identical |
EN 12006-1 : 1999 | Identical |
UNI EN 12006-1 : 2001 | Identical |
ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
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