ÖNORM EN ISO 8637-1:2020-10

Действует

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

Описание Изменения Ссылки Версии

Ссылочные документы

ISO 10993-1:2009/Cor.1:2010

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process -- Technical Corrigendum 1 — 1 стр.

ISO 10993-4:2002/Amd.1:2006

Заменен

Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood -- Amendment 1 — 10 стр.

ISO 10993-7:2008/Cor.1:2009

Действует

Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals -- Technical Corrigendum 1 — 2 стр.

ISO 10993-11:2017

Действует

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 36 стр.

ISO 80369-7:2016

Действует

Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications — 52 стр.

ÖNORM EN ISO 8637:2014-03

Заменен

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)

На этот документ ссылаются

DIN EN ISO 7199:2017-05

Отменен

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016); German version EN ISO 7199:2017 — 31 стр.

ÖNORM EN ISO 8637:2014-03

Заменен

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)