Biomedical Engineering Reference
In-Depth Information
Table 9.7
Japanese MHW test selection guidelines
Device
categories
Body contact
Contact
duration
Initial evaluation
Supplemental evaluation
Cytoto-
xicity
Sensiti-
zation
Irritation
or intra-
cutane-
ous
Systemic
toxicity
(acute)
Sub-
chronic
toxicity
Genoto-
xicity
Pyro-
gen
Implan-
tation
Hemo-
compati-
bility
Chronic
toxicity
Carcino-
genicity
Surface
devices
Skin
A
X
X
X
B
X
X
X
C
X
X
X
Mucosal
membrane
A
X
X
X
B
X
X
X
C
X
X
X
X
X
Breached/
compro-
mised
surface
A
X
X
X
B
X
X
X
C
X
X
X
X
X
Blood path
indirect
A
X
X
X
X
X
X
Externally
com-
muni-
cating
devices
B
X
X
X
X
X
X
C
X
X
X
X
X
X
X
X
X
Tissue/bone
dentin
communi-
cating
A
X
X
X
B
X
X
X
X
C
X
X
X
X
X
Circulating
blood
A
X
X
X
X
X
X
B
X
X
X
X
X
X
X
C
X
X
X
X
X
X
X
X
X
X
Implant
devices
Bone/tissue
A
X
X
X
B
X
X
X
X
C
X
X
X
X
X
X
Blood
A
X
X
X
X
X
X
X
B
X
X
X
X
X
X
X
X
C
X
X
X
X
X
X
X
X
X
X
X
Notes
: A = Temporary contact (<24 h); B = Short and medium term contact (24 h-29 days); C = Long term contact (>30 days).
