BS EN ISO 5840-3:2021 - Cardiovascular implants. Cardiac valve prostheses. Heart valve substitutes implanted by transcatheter techniques

BS EN ISO 5840-3:2021

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

Status : Current   Published : February 2021

Format
PDF

Format
HARDCOPY



This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.

This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).




Standard NumberBS EN ISO 5840-3:2021
TitleCardiovascular implants. Cardiac valve prostheses. Heart valve substitutes implanted by transcatheter techniques
StatusCurrent
Publication Date08 February 2021
Normative References(Required to achieve compliance to this standard)ISO 14971, ISO 10993-2, ISO 14630, IEC 62366 (all parts), ISO 14155, ISO 5840-1:2021
Informative References(Provided for Information)ISO 25539-1, ASTM F2079, IEC 60601-1 (all parts), ASTM F2081, ISO 10555-1, ASTM F3067, ISO 5840-2:2021
ReplacesBS EN ISO 5840-3:2013
International RelationshipsEN ISO 5840-3:2021,ISO 5840-3:2021
Draft Superseded By19/30385881 DC
DescriptorsRisk assessment, In vivo testing, Clinical testing, Hazards, Acceptance (approval), Cardiology, Packaging, Implants (surgical), Prosthesis, Performance testing, Heart, Sterilization (hygiene), Physical properties of materials, Valves, Labels, Prosthetic devices, Reports, Instructions for use, Circulatory system, Performance, Life (durability), Verification, Design, Medical equipment, Classification systems
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 0 539 02794 5
PublisherBSI
FormatA4
DeliveryYes
Pages66
File Size2.402 MB
Price£260.00


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