AS/NZS 4810.1:2000
Withdrawn
Medical devices - Risk management Application of risk analysis
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
05-18-2000
04-27-2018
Specifies a procedure for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. Does not stipulate levels of acceptability nor is it intended to give guidance on all aspects of management of risks. This Standard is identical with and has been reproduced from ISO 14971-1:1998.
| Committee |
H-000
|
| DocumentType |
Standard
|
| ISBN |
0 7337 3319 0
|
| Pages |
17
|
| PublisherName |
Standards Australia
|
| Status |
Withdrawn
|
| Supersedes | |
| UnderRevision |
| Standards | Relationship |
| ISO 14971-1:1998 | Identical |
First published as AS/NZS 4810-1:2000.
This standard has been withdrawn and is no longer current. No replacement edition is available.