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Provides guidance to manufacturers that change existing or create new alarm systemalgorithms as to how to create evidence that demonstrates a reasonable assurance of the safety and efficacy of the algorithm. This document also provides guidance to authorities having jurisdiction for the assessment of such evidence.
Product Details
- Published:
- 02/28/2017
- ISBN(s):
- 9781570206528
- Number of Pages:
- 34
- File Size:
- 1 file , 480 KB