هيئة المواصفات والمقاييس العربية السورية
The Syrian Arab Organization For Standardization & Metrology
3991
11.100.20
50
National - Accredited - non-mandatory
new
Quality
2020-12-24
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
This Syrian national standard specifies: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of medical devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyze the biological safety of the medical device; the assessment of the biological safety of the medical device.
ISO 10993-1/2018