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STANDARD

Current

ÖNORM EN ISO 22442-2

Issue date: 2021 05 15

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1. This document does not cover the utilization of human tissues in medical devices. This document does not specify a quality management system for the control of all stages of production of medical devices.

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General information on ÖNORM EN ISO 22442-2

Format

Digital | 27 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 22442-2 from 2000 til today.

• ÖNORM EN ISO 22442-2

  2021 05 15 Standard ÖNORM EN ISO 22442-2, Edition: 2021 05 15

  Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, colle...
• ÖNORM EN ISO 22442-2

  2016 03 15 Standard ÖNORM EN ISO 22442-2, Edition: 2016 03 15

  Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, colle...
• ÖNORM EN ISO 22442-2

  2008 04 01 Standard ÖNORM EN ISO 22442-2, Edition: 2008 04 01

  Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, colle...
• ÖNORM EN 12442-2

  2000 12 01 Standard ÖNORM EN 12442-2, Edition: 2000 12 01

  Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Contro...

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Frequently Asked Questions about ÖNORM EN ISO 22442-2

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 22442-1:2020	Titel Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management	Ausgabedatum 2020 09 15	Art Standard	Zur Produktseite

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