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. Specifies, in
conjunction with ANSI/AAMI/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. Outlines the decision process for the
residual risk acceptability, taking into account the balance of residual risk, as defined in
ANSI/AAMI/ISO 14971, and expected medical benefit as compared to available alternatives. This
part of ANSI/AAMI/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.
| ANSI : | ANSI Approved |
| File Size : | 1
file
, 400 KB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 39 |
| Published : | 01/25/2008 |
