Standard Swedish standard · SS-EN ISO 22442-1:2015

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)

Status: Withdrawn

· Replaced by: SS-EN ISO 22442-1:2020
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Standard Swedish standard · SS-EN ISO 22442-1:2015

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
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Scope
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 identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This part of ISO 22442 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such asa) contamination by bacteria, moulds or yeasts;b) contamination by viruses;c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);d) material responsible for undesired pyrogenic, immunological or toxicological reactions.For parasites and other unclassified pathogenic entities, similar principles can apply.This part of ISO 22442 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices.This part of ISO 22442 does not cover the utilization of human tissues in medical devices.

Subjects

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


Buy this standard

Standard Swedish standard · SS-EN ISO 22442-1:2015

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
Subscribe on standards - Read more Dölj
Price: 1 320 SEK
standard ikon pdf

PDF

Price: 1 320 SEK
standard ikon

Paper

Price: 2 112 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-8017738

Edition: 2

Approved: 12/1/2015

No of pages: 44

Replaces: SS-EN ISO 22442-1:2007

Replaced by: SS-EN ISO 22442-1:2020