Risk Management


EN 13641

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

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EN ISO 14971

Medical devices - Application of risk management to medical devices

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EN ISO 22442-1

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

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EN ISO 22442-2

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

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EN ISO 22442-3

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

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