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AS/NZS 4810.1:2000

Withdrawn

Withdrawn

Medical devices - Risk management Application of risk analysis

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

05-18-2000

Withdrawn date

04-27-2018

US$71.73
Excluding Tax where applicable
Summarise this standard

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Withdrawn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This standard has been withdrawn and is no longer current.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.

US$71.73
Excluding Tax where applicable