Biomedical Engineering Reference
In-Depth Information
TABLE 2.1
Initial Evaluation Tests for Consideration
Device Categories
Biological Effect
Contact
Duration
(see 4.2)
A—Limited
(24 h)
B—Prolonged
(24 h to 30
days)
C—Permanent
(>30 days)
Body Contact
(see 4.1)
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
o
o
o
C
x
x
x
o
x
x
o
Breached or
Compromised
Surfaces
A
x
x
x
o
B
x
x
x
o
o
o
C
x
x
x
o
x
x
o
External
Communicating
Devices
Blood Path, Indirect
A
x
x
x
x
x
B
x
x
x
x
o
x
C
x
x
o
x
x
x
o
x
Tissue/Bone/
Dentin
Communicating+
A
x
x
x
o
B
x
x
o
o
o
x
x
C
x
x
o
o
o
x
x
Circulating Blood
A
x
x
x
x
o^
x
B
x
x
x
x
o
x
o
x
C
x
x
x
x
x
x
o
x
Implant Devices
Tissue/Bone
A
x
x
x
o
B
x
x
o
o
o
x
x
C
x
x
o
o
o
x
x
Blood
A
x
x
x
x
x
x
B
x
x
x
x
o
x
x
x
C
x
x
x
x
x
x
X
x
Note:
X = ISO Evaluation Tests for consideration.
O:
Additional tests that may be applicable.
+:
Tissue includes tissue fluids and subcutaneous spaces.
^:
For all devices used in extracorporial circuits.
