BS EN ISO 5840-2:2015 - Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes

BS EN ISO 5840-2:2015

Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes

Status : Superseded, Withdrawn   Published : October 2015 Replaced By : BS EN ISO 5840-2:2021

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Standard NumberBS EN ISO 5840-2:2015
TitleCardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes
StatusSuperseded, Withdrawn
Publication Date31 October 2015
Withdrawn Date08 February 2021
Normative References(Required to achieve compliance to this standard)ISO 5840-1:2015, ISO 14971, ASTM F2119, ASTM F2182, ISO 22442, ASTM F2052, ISO 10993-2, ASTM F2213, ISO/IEC 17025:2005, ASTM F2503, ISO 14155, ISO 10993-1, ISO 14630, ISO 16061
Informative References(Provided for Information)ISO 17665-1:2006, ISO 11135, ISO 532:1975, ISO 11137, ISO 11607, ISO 14937, ISO 13485, IEC 60651, ISO/TS 12417:2011, IEC 62366, ISO/TS 11139:2006, ISO 25539-1:2003, ISO 8601, ISO 14160
Replaced ByBS EN ISO 5840-2:2021
ReplacesBS EN ISO 5840:2009
International RelationshipsISO 5840-2:2015,EN ISO 5840-2:2015
Draft Superseded By14/30281560 DC
DescriptorsLife (durability), Verification, Reports, Performance testing, Packaging, Performance, Cardiology, Prosthetic devices, Labels, Clinical testing, Hazards, Physical properties of materials, Sterilization (hygiene), Classification systems, Prosthesis, Design, Medical equipment, Acceptance (approval), Instructions for use, Implants (surgical), In vivo testing, Circulatory system, Valves, Risk assessment, Heart
ICS11.040.40
Title in FrenchImplants cardiovasculaires. Prothèses valvulaires. Prothèse valvulaires implantées chirurgicalement
Title in GermanHerz- und Gefäßimplantate. Herzklappenprothesen. Chirurgisch implantierter Herzklappenersatz
CommitteeCH/150/2
ISBN978 0 580 82708 2
PublisherBSI
FormatA4
DeliveryYes
Pages66
File Size2.438 MB
Price£260.00


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