DIN EN ISO 22442-1:2021
DIN · 2021-08-00

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

Replaced

1Key Takeaways

This Part of ISO 22442 applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to investigate, usin

2Scope / Description

This Part of ISO 22442 applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to investigate, usin

3Version History

DIN EN ISO 22442-1 older
DIN EN ISO 22442-1:2016 newer
DIN EN ISO 22442-1:2018 newer

5Citation Network

0
Cite this standard
31
Referenced herein
ISO 10993-1 ISO 10993-10 ISO 10993-11 ISO 10993-12 ISO 10993-13 ISO 10993-14 ISO 10993-15 ISO 10993-16

6Frequently Asked Questions

What is DIN EN ISO 22442-1:2021?
DIN EN ISO 22442-1:2021 — Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020 is an international standard developed by German Institute for Standardization. This Part of ISO 22442 applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a...
What does DIN EN ISO 22442-1:2021 cover?
This standard covers: This Part of ISO 22442 applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to investigate, usin
Who should use this standard?
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.
What is the latest version of DIN EN ISO 22442-1:2021?
The current published version is DIN EN ISO 22442-1:2021, published on 2021-08-00. Always check for amendments or pending revisions.
How do I purchase DIN EN ISO 22442-1:2021?
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