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Provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. The TIR incorporates the expanded view of risk management from IEC 80001-1 by incorporating the same key properties of Safety, Effectiveness and Data & Systems Security with Annexes that provide process details and illustrative examples.
Product Details
- Published:
- 06/05/2016
- ISBN(s):
- 9781570206122
- ANSI:
- ANSI Approved
- Number of Pages:
- 84
- File Size:
- 1 file , 4.8 MB
