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PD ISO/TR 22442-4:2010

Действует
Medical devices utilizing animal tissues and their derivatives. Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes — 24 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 14160:2011
Действует
Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices — 42 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.
ISO 22442-2:2007
Заменен
Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling — 24 стр.
ISO 22442-1:2007
Заменен
Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management — 34 стр.