19/30385869 DC - BS EN ISO 5840-1. Cardiovascular implants. Cardiac valve prostheses. Part 1. General requirements

19/30385869 DC

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

Status : Current, Draft for public comment   Published : January 2019

Format
PDF

Format
HARDCOPY






Standard Number19/30385869 DC
TitleBS EN ISO 5840-1. Cardiovascular implants. Cardiac valve prostheses. Part 1. General requirements
StatusCurrent, Draft for public comment
Publication Date23 January 2019
Normative References(Required to achieve compliance to this standard)ISO 14630, ISO/TR 22442-4, ISO 11137 (all parts), ASTM F2182, ISO 10993-1, ISO 22442-1, ISO 13485, ISO 11607 (all parts), ASTM F2503, ISO 176651, ISO 22442-2, ASTM F2119, ISO 5840-2, ASTM F2052, ISO 5840-3, ISO 10993-4, ISO/IEC 17025, IEC 62366, ASTM F2213, ISO 22442-3, ISO 14155, ISO 14160, ASTM F1830 ? 97, ISO 11135, ISO 14937, ISO 14971
Informative References(Provided for Information)ISO/TS 11139, ISO 25539-1
International RelationshipsISO/DIS 5840-1
Draft Expiry Date09 March 2019
DescriptorsHeart, Cardiology, Medical equipment, Labels, Life (durability), Hazards, Performance testing, Prosthesis, Valves, Prosthetic devices, Implants (surgical), In vivo testing, Packaging, Performance, Risk assessment, Reports, Verification, Design, Instructions for use, Classification systems, Physical properties of materials, Sterilization (hygiene), Circulatory system, Clinical testing, Acceptance (approval)
ICS11.040.40
Title in FrenchImplants cardiovasculaires -- Prothèses valvulaires Partie 1: Exigences générales
CommitteeCH/150/2
PublisherBSI
FormatA4
DeliveryYes
Pages80
File Size2.702 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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