ÖNORM EN ISO 22442-1:2021-05

Действует

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

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 14971:2007

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

ISO 22442-2:2007

Заменен

Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling — 24 стр.

ISO 22442-3:2007

Действует

Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/ or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents — 30 стр.

ÖNORM EN ISO 22442-1:2016-04

Заменен

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)

На этот документ ссылаются

ÖNORM EN ISO 22442-1:2016-04

Заменен

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)