BSI BS EN 12006-1 Non-Active Surgical Implants - Particular Requirements for Cardiac and Vascular Implants - Part 1: Heart Valve Substitutes
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BSI BS EN 12006-1 Document Information:
Title
Non-Active Surgical Implants - Particular Requirements for Cardiac and Vascular Implants - Part 1: Heart Valve Substitutes
Nichtaktive chirurgische Implantate. Besondere Anforderungen fuer Herz und Gefaessimplantate. Herzklappenprothesen
Implants chirurgicaux non actifs. Exigences particulieres pour les implants cardiovasculaires. Protheses valvulaires cardiaques
British Standards Institution
Publication Date:
Nov 15, 1999
Scope:
To be read in conjunction with BS EN ISO 14630:1998
Keywords:
- Implants (surgical)
- Circulatory system
- Prosthesis
- Medical equipment
- Cardiology
- Heart
- Valves
- Blood vessels
- Performance
- Design
- Product design
- Design calculations
- Production
- Packaging
- Instructions for use
- Consumer-supplier relations
- Performance testing
- Biological analysis and testing
- Chemical analysis and testing
- Determination of content
- Chemical properties
- Mechanical testing
- Torsion testing
- Pressure testing
- Deformation
- Dynamic testing
- Hydrostatics
- Flow measurement
- Leak tests
- Clinical testing
- Life (durability)
- Reports
- Testing conditions
- Marking
- Classification systems
- Physical properties of materials
- Mechanical properties of materials
- Sterilization (hygiene)
- Inspection
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