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EVS-EN ISO 5840-1:2021

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)

Üldinfo
Kehtiv alates 15.02.2021
Alusdokumendid
ISO 5840-1:2021; EN ISO 5840-1:2021
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
15.02.2021
Põhitekst
04.11.2015
Põhitekst
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are 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. ISO 5840-1 defines operational conditions for heart valve substitutes. ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3. ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable. NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A.
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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 ISO 5840-3:2021

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