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

DIN EN ISO 22442-1:2021-04 — Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020) is an international standard developed by German Institute for Standardization. This standard specifies the application of risk management to medical devices incorporating animal tissues and their derivatives. It is part one of a series and aligns with international guidelines for ensuring safety and efficacy in the...

This standard covers: This standard specifies the application of risk management to medical devices incorporating animal tissues and their derivatives. It is part one of a series and aligns with international guidelines for ensuring safety and efficacy in the development, production, and use of such medical devices.

This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.

The current published version is DIN EN ISO 22442-1:2021-04, published on 2021-04-01. Always check for amendments or pending revisions.

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