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EVS-EN ISO 5840-3:2021

Kardio-vaskulaarsed implantaadid. Südameklapi proteesid. Osa 3: Kateetri kaudu implanteeritavad asendusklapid

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Kehtiv alates 15.02.2021
Alusdokumendid
ISO 5840-3:2021; EN ISO 5840-3:2021
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
15.02.2021
Põhitekst
02.04.2013
Põhitekst
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).
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EVS-EN ISO 5840-1:2021

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
Uusim versioon Kehtiv alates 15.02.2021
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EVS-EN ISO 5840-2:2021

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)
Uusim versioon Kehtiv alates 15.02.2021
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EVS-EN IEC 60812:2018

Failure modes and effects analysis (FMEA and FMECA)
Uusim versioon Kehtiv alates 02.11.2018
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EVS-EN ISO 10993-15:2009

Meditsiiniseadmete bioloogilise sobivuse hindamine. Osa 15: Metallide ja sulamite laguproduktide kindlaksmääramine ja koguseline tuvastamine
Uusim versioon Kehtiv alates 07.08.2009