TSE - TS EN ISO 22442-1
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
active, Most Current
| Organization: | TSE |
| Publication Date: | 24 March 2016 |
| Status: | active |
| ICS Code (Other standards related to laboratory medicine): | 11.100.99 |
scope:
This part of ISO 22442 applies to medical devices other than invitro diagnostic medical devices manufactured utilizing materialsof animal origin, which are non-viable or have been renderednonviable. It specifies, in conjunction with ISO 14971, a procedureto identify the hazards and hazardous situations associated withsuch devices, to estimate and evaluate the resulting risks, tocontrol these risks, and to monitor the effectiveness of thatcontrol.
Document History
TS EN ISO 22442-1
March 24, 2016
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
This part of ISO 22442 applies to medical devices other than invitro diagnostic medical devices manufactured utilizing materialsof animal origin, which are non-viable or have been renderednonviable....
April 29, 2008
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
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