Classification Rules
Rule 1
1(a) A non-invasive device to be used as a mechanical barrier or for compression or for absorption of exudates—Class A.
Rule 2
2(a) A non-invasive device used to channel or store body liquids or tissues, liquids or gases that are to be infused, administered or introduced into a patient—Class A.
Rule 4
A non-invasive device is Class A, unless the device is classified at a higher level under another rule.
Rule 5
5(a) Invasive devices that are not connected to an active medical device, or are intended for connection to a Class A medical device only and are for transient use—Class A.
5(c) Invasive devices that are for short-term use in the oral cavity as far as the pharynx, in an ear canal to the ear drum, or in a nasal cavity—Class A.
Rule 6
6(b) A reusable surgical instrument—Class A.
Rule 12
An active device is Class A, unless the device is classified at a higher level under another rule.
Rule 14
14(b) Devices that only contains animal tissues that have been rendered non-viable and the device is only intended by the manufacturer to come into contact with intact skin – Class A
Rule 15
15(c) A device specifically for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses - Class C.
Note: this clause does not apply to a medical device that is intended only to clean another medical device (other than contact lenses) by means of physical action—these devices are Class A.
Examples |
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absorbent pads |
active devices for recording |
Adhesive dressing strip—not sterile |
administration sets for gravity infusion |
artery forceps |
cervical collars and gravity traction devices or compression hosiery |
chisels |
Compression bandage used for sprains |
cotton wool |
cotton wool |
Dental curing lights |
dental impression materials |
dental patient chairs |
dentures removable by the patient |
diagnostic devices for thermography |
dressing for nose bleeds |
exam gloves |
examination lights |
excavators |
handheld dental mirrors |
hospital beds |
island dressings |
island dressings |
leather straps associated with limb prostheses |
non-sterile dressings |
osteotomes |
ostomy pouches |
patient hoists |
plaster bandages |
processing or viewing of diagnostic images |
prostatic balloon dilation catheters |
scissors |
surgical microscopes |
syringes without needles |
tissue clamps |
tissue forceps |
urine collection bottles |
wheelchairs |
wound drainage collection bottles and incontinence pads |
wound strips and gauze dressings to act as a barrier or absorb exudates from the wound |
wound strips and gauze dressings to act as a barrier or absorb exudates from the wound. |