AS EN 12442.3-2003

AS EN 12442.3-2003 Animal tissues and their derivatives utilized in the manufacture of medical devices - Validation of the elimination and/or inactivation of viruses and transmissible agents
standard by Standards Australia, 01/01/2003

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Full Description

Specifies requirements for the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing materials of animal origin. It is not applicable to bacteria, moulds and yeasts.