
Medical devices - Risk management Part 1: Application of risk analysis
出版:Standards Australia

专家解读视频
Proposes the adoption of ISO 14971-1:1998 which specifies a procedure for investigating the safety of a medical device by identifying hazards and estimating the risks associated with the device. Not intended to give guidance on all aspects of management of risks. The complete text can be viewed at the Sydney and Melbourne Information Centres of Standards Australia or at Standards New Zealand. Arrangements can be made to view copies at other Standards Australia branches if required. Proposed as a Joint Australian/New Zealand Standard.