BS EN ISO 22442-2:2007

Заменен

Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling — 28 стр.

Ссылочные документы

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.

ISO 14971:2007

Действует

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

ISO 13485:2003/Cor.1:2009

Заменен

Medical devices -- Quality management systems -- Requirements for regulatory purposes -- Technical Corrigendum 1 — 2 стр.

ISO 9001:2015

Действует

Quality management systems -- Requirements — 40 стр.

ISO 22442-1:2007

Заменен

Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management — 34 стр.

На этот документ ссылаются

BS EN ISO 22442-2:2015

Действует

Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling — 30 стр.

BS EN 12442-2:2000

Заменен

Animal tissues and their derivatives utilized in the manufacture of medical devices, Controls on sourcing, collection and handling — 20 стр.