BS EN ISO 5840-1:2015 - Cardiovascular implants. Cardiac valve prostheses. General requirements

BS EN ISO 5840-1:2015

Cardiovascular implants. Cardiac valve prostheses. General requirements

Status : Current, Under review   Published : October 2015



Standard NumberBS EN ISO 5840-1:2015
TitleCardiovascular implants. Cardiac valve prostheses. General requirements
StatusCurrent, Under review
Publication Date31 October 2015
Normative References(Required to achieve compliance to this standard)ISO 14630:2012, ISO 11137, ISO 5840-2, ISO 11607, ISO 14971, ISO 5840-3, ISO 11135, ISO 14160, ISO 14155, ISO 14937, ISO 17665
Informative References(Provided for Information)ISO/TS 11139:2006, ISO 25539-1:2003, ISO 532:1975, ISO 13485, IEC 60651:1973, ISO/IEC 17025, ISO/TS 12417:2011, ISO 22442-3, ISO 22442-2, ISO 22442-1, ISO 16061, ASTM F2213, ASTM F2119, ASTM F2052, ASTM F2182, ASTM F2503, IEC 62366
International RelationshipsEN ISO 5840-1:2015,ISO 5840-1:2015
Draft Superseded By14/30270462 DC
DescriptorsImplants (surgical), Physical properties of materials, Reports, Clinical testing, Instructions for use, Prosthesis, Acceptance (approval), Life (durability), Cardiology, Sterilization (hygiene), Valves, Classification systems, Hazards, Prosthetic devices, Circulatory system, Labels, Design, Risk assessment, Heart, Medical equipment, Verification, Performance testing, In vivo testing, Performance, Packaging
Title in FrenchImplants cardiovasculaires. Prothèses valvulaires. Exigences générales
Title in GermanHerz- und Gefäßimplantate. Herzklappenprothesen. Allgemeine Anforderungen
ISBN978 0 580 80484 7
File Size1.716 MB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Develop a PAS

Develop a fast-track standardization document in 9-12 months

Worldwide Standards
We can source any standard from anywhere in the world

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version

Customers who bought this product also bought

  • BS EN ISO 5840-2:2015
    Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes
  • BS EN ISO 5840-3:2013
    Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques