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

BS EN ISO 5840-3:2013

Cardiovascular implants. Cardiac valve prostheses. Heart valve substitutes implanted by transcatheter techniques

Status : Superseded, Withdrawn   Published : April 2013 Replaced By : BS EN ISO 5840-3:2021

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Standard NumberBS EN ISO 5840-3:2013
TitleCardiovascular implants. Cardiac valve prostheses. Heart valve substitutes implanted by transcatheter techniques
StatusSuperseded, Withdrawn
Publication Date30 April 2013
Withdrawn Date08 February 2021
Normative References(Required to achieve compliance to this standard)ASTM F2052, ISO 22442-3, ISO 10993-1, ISO 11137-1, ISO 14937, ISO 22442-1, ISO 11607-2, ISO 11607-1, ISO 22442-2, ISO/TS 11135-2, ASTM F2213, ISO 14971, ISO/IEC 17025, ISO 11135-1, ISO 11137-2, ISO 14155, ISO 14630:2012, ASTM F2182, ISO 10993-2, IEC 62366, ASTM F2503, ASTM F2119, ISO 14160, ISO 17665-1, ISO 11137-3:2017
Informative References(Provided for Information)ISO 8601, ISO 13485, ISO/TS 11139, ISO 25539-1ANSI/AAMI HE75, ISO 5840:2005, ISO 10555-1, EuroSCORE, 93/42/EEC
Replaced ByBS EN ISO 5840-3:2021
International RelationshipsISO 5840-3:2013,EN ISO 5840-3:2013
Draft Superseded By11/30219211 DC
DescriptorsCardiology, Sterilization (hygiene), Instructions for use, Prosthesis, Implants (surgical), Medical equipment, Heart, Classification systems, Packaging, Performance testing, Physical properties of materials, Clinical testing, Circulatory system, Reports, In vivo testing, Risk assessment, Labels, Acceptance (approval), Design, Verification, Hazards, Life (durability), Performance, Prosthetic devices, Valves
ICS11.040.40
Title in FrenchImplants cardiovasculaires. Prothèses valvulaires. Valves cardiaques de substitution implantées par des techniques transcathéter
Title in GermanHerz- und Gefäßimplantate. Herzklappenprothesen. Durch minimal-invasive Methoden implantierter Herzklappenersatz
CommitteeCH/150/2
ISBN978 0 580 71177 0
PublisherBSI
FormatA4
DeliveryYes
Pages118
File Size2.348 MB
Price£298.00


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