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Risk management - Risk assessment techniques

...Note 3 to entry: Taking or not taking an opportunity are both sources of risk...
...3 probability measure of the chance of occurrence expressed as a number between 0 and 1, where 0 is impossibility and 1 is absolute certainty Note 1 to entry: See definition 3...
...4 risk driver driver of risk factor that has a major influence on risk 3...

Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

...of device materials on male/female reproductive organs or from subacute/chronic study on the histopathology of reproductive system should also form the basis before a full scale reproductive toxicity testing is performed...
...of genetic damage: Gene mutations (point mutations); Chromosomal damage [structural aberrations such as translocations, small or large deletions and insertions, and numerical chromosomal aberrations (aneuploidy)]...
...1 General No single test is capable of detecting all relevant genotoxic agents...