Back

EVS-EN ISO 22442-1:2015

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

General information
Withdrawn from 31.12.2020
Base Documents
ISO 22442-1:2015; EN ISO 22442-1:2015
Directives or regulations
None
Standard history
Status
Date
Type
Name
31.12.2020
Main
05.01.2016
Main
07.02.2008
Main
EVS-EN ISO 22442-1:2008
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 nonviable. 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 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.
*
*
*
PDF
17.63 € incl tax
Paper
17.63 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

EVS-EN ISO 22442-2:2015

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
Withdrawn from 31.12.2020
Main

EVS-EN ISO 22442-3:2008

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
Newest version Valid from 07.02.2008
Main

EVS-EN ISO 14644-1:2015

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
Newest version Valid from 05.01.2016
Main

EVS-EN ISO 14644-2:2015

Cleanrooms and associated controlled environments - Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1 (ISO 14644-2:2015)
Newest version Valid from 05.01.2016