Skip to main content
Tagasi

EVS-EN ISO 5840-2:2021

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)

Üldinfo

Kehtiv alates 15.02.2021
Alusdokumendid
ISO 5840-2:2021; EN ISO 5840-2:2021
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
Muudatus
EN ISO 5840-2:2021/prA1
15.02.2021
Põhitekst
04.11.2015
Põhitekst
This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a surgical 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 surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.

Nõutud väljad on tähistatud *

*
*
*
PDF
31,72 € koos KM-ga
Paber
31,72 € koos KM-ga
Sirvi standardit alates 2,44 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Põhitekst

EVS-EN ISO 5840-3:2021

Kardio-vaskulaarsed implantaadid. Südameklapi proteesid. Osa 3: Kateetri kaudu implanteeritavad asendusklapid
Uusim versioon Kehtiv alates 15.02.2021
Põhitekst

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
Põhitekst + muudatus

EVS-EN ISO 13485:2016+A11:2021

Meditsiiniseadmed. Kvaliteedijuhtimissüsteemid. Normatiivsed nõuded
Uusim versioon Kehtiv alates 16.09.2021
Põhitekst + muudatus

EVS-EN ISO 10993-7:2008+A1:2022

Meditsiiniseadmete bioloogiline hindamine. Osa 7: Jäägid etüleenoksiidiga steriliseerimisest
Uusim versioon Kehtiv alates 01.02.2022