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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)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 594-2:1998
Заменен
Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings — 16 стр.
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.
ÖNORM EN ISO 8637-1:2020-10
Действует
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
ÖNORM EN 1283:1996-10
Заменен
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits

На этот документ ссылаются

DIN EN ISO 7199:2014-02
Отменен
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012); German version FprEN ISO 7199:2014 — 18 стр.
ÖNORM EN 1283:1996-10
Заменен
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
ÖNORM EN ISO 8637-1:2020-10
Действует
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)