Medical devices – Risk management, Part 1: Application of risk analysis

Published by	Publication Date	Number of Pages
AS/NZS	05/18/2000	17

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Category: AS-NZS

Description

AS/NZS 4810.1 – Medical devices – Risk management, Part 1: Application of risk analysis

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.