Silicone Foam Dressing Risk Management Report
3_| Risk evatuation ertoria
3.4 | The classification ofthe seventy of damage
: ‘Severity Level ‘Classification orteria
: ‘st | nestinie _with tle oF no possibilty of potentat harm
's2_| marginal ‘causes @ mild infection or Injury
i 83. | creat ea to severe ife-treatening infection or serious inky
84 _| catastrophic ead to Me-hreatening infection
32 | Probability levels
|
| Proabity Evert tequendy yea unt of product
1 [ave i
P2_| probable =o"
| 3 | exxasona erg
P4 | remote 10?~10%
PS | unlikely 10*~10*
PG | incredibie <10*
33 | Acceptance cteia
saaiy
Probability
st o 8 a
freq LARP wace wace Nace
probate ALaRP LARP ace wixce
eccsional ALARP LARP ‘LARP wace
renee nce LARP ALARP LARP
i
| unlikely, ACC ACG ALARP- ALARP-
‘ocean ace ace nee nec
(NAGG- unacceptable District; the ACC-scceptable; ALARP-easonably practicable low love area)
To take all raining risk measures, on the one hand, does not alow N / ACC level of risk; the other hand, the
Fiske inthe ALARP level must be less than 9wer
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