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 |
|---|
| 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. |