Spotlight on Australia: Life and Health Sciences
Different types
and classes of
Medical
Benefit vs. risk approach
Medical devices (not including in vitro diagnostics)
Devices
I
i
Class
Risk
Examples
Class I
Low
Tongue depressors, slings
Class - supplied sterile
Low-
medium
Class - incorporating a
Some bandages, wound dressings, catheters
Medicine cups with defined units
measuring function
Class lla
Intravenous tubing, syringes for infusion pumps
Class llb
Medium
Lung ventilators, medical device disinfectants, some
implantable devices (e.g. urethral stents)
Class III
High
Heart valves, devices containing medicines or tissues, cells or
substances of animal, biological or microbiological origin
Active implantable medical High
device (AIMD)
Implantable defibrillators
MyMedical
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