DR 03114 CP
Superseded
Superseded
View Superseded by
Animal tissues and their derivatives utilized in the manufacture of medical devices Part 1: Analysis and management of risk
Published date
02-28-2003
Publisher
Superseded date
10-26-2017
Superseded by
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Proposes a procedure to investigate, using available information, the safety of medical devices by identifying hazards and estimating the risks associated with the device (risk analysis). EN 12442.1 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendererd non-viable.
| CommentClosesDate |
04-15-2003
|
| Committee |
HE-012
|
| DocumentType |
Draft
|
| PublisherName |
Standards Australia
|
| Status |
Superseded
|
| SupersededBy |
To be AS EN 12442.1
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