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Norm
ÖNORM EN ISO 22442-1
Issue date: 2021 05 15
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have be...
Valid
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 42 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document 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 document 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 as:
a) 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 document 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 document does not specify a quality management system for the control of all stages of production of medical devices.
This document does not cover the utilization of human tissues in medical devices.
ÖNORM EN ISO 22442-1
2021 05 15
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk managem...
Norm
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ÖNORM EN ISO 22442-1
2016 04 01
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk managem...
Norm
ÖNORM EN ISO 22442-1
2008 04 01
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk managem...
Norm
ÖNORM EN 12442-1
2000 12 01
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analys...
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Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
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Issue date :
2020 09 15
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
Norm
Issue date :
2007 11 27
Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Norm
Issue date :
2020 09 15
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management