Standard Swedish standard · SS-EN ISO 22442-2:2020

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

Status: Valid

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Standard Swedish standard · SS-EN ISO 22442-2:2020

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
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Scope
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.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.
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.

Subjects

Biological evaluation of medical devices (11.100.20) Other (11.100.99)


Buy this standard

Standard Swedish standard · SS-EN ISO 22442-2:2020

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
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Price: 919 SEK
standard ikon pdf

PDF

Price: 919 SEK
standard ikon

Paper

Price: 1 470,40 SEK
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Product information

Language: English

Written by: Std Vård

International title:

Article no: STD-80026690

Edition: 3

Approved: 12/16/2020

No of pages: 32

Replaces: SS-EN ISO 22442-2:2015