Class A

Classification Rules

1(a) A non-invasive device to be used as a mechanical barrier or for compression or for absorption of exudates—Class A.
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.
A non-invasive device is Class A, unless the device is classified at a higher level under another rule.
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.
6(b) A reusable surgical instrument—Class A.
An active device is Class A, unless the device is classified at a higher level under another rule.
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
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.