Class B

Rules for Classification

1(b) A non-invasive device to be used in contact with injured skin (including a device the principal intention of which is to manage the microenvironment of a wound)—Class B.

2(b) A non-invasive device to channel or store a liquid or gas that is to be infused, administered or introduced into a patient and may be connected to an active medical device classified as Class B or higher—Class B.

2(c) A non-invasive device to channel blood, to store or channel other body liquids, or to store an organ, parts of an organ or body tissue that is to be later introduced into a patient—Class B.

3(b) A non-invasive device to be used in treatment consisting of filtration, centrifugation or exchanges of gas or heat—Class B.

5(b) 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 short- term use—Class B.

5(e) Invasive devices for long-term use in the oral cavity as far as the pharynx or in an ear canal to the ear drum, or in a nasal cavity and are not liable to be absorbed by the mucous membrane—Class B.

5(f) Invasive device with respect to body orifices, to be connected to an active medical device that is classified as Class B or higher—Class B.

6(a) Surgically invasive device for transient use—Class B.

7(a) Surgically invasive device for short-term use—Class B.
7(i) A surgically invasive device for short-term use that is intended by the manufacturer to be placed in the teeth and to undergo a chemical change in the body—Class B. Note: for this clause, a medical device to be placed in the teeth includes a device that is intended to penetrate a tooth but that does not enter the gum or bone beyond the tooth.
8(b) A surgically invasive device for long-term use to be placed in the teeth—Class B.
8(m) A surgically invasive device for long-term use that is intended by the manufacturer to be placed in the teeth and to undergo a chemical change in the body is Class B. Note: for this rule a medical device to be placed in the teeth includes a device that is intended to penetrate a tooth but does not enter the gum or bone beyond the tooth.

9 (i)(a) An active medical device for therapy to administer energy to a patient, or exchange energy to or from a patient—Class B.

10(i)(a) A device to supply energy that will be absorbed by a patient’s body (except a device that illuminates the patient’s body in the visiblespectrum)—Class B.

10(i)(b) A device to be used to image in vivo distribution of radiopharmaceuticals in patients—Class B.

10(i)(c) A device used for direct diagnosis or monitoring of vital physiological processes of a patient, excluding devices mentioned in the previous entry—Class B.

11 (a) An active device to administer or remove medicine, body liquids or other substances—Class B.

15(b) A device intended for disinfecting medical devices prior to end point sterilisation or higher level disinfection – Class B

Examples
warming or cooling blood in the extracorporeal circulatory system
cardioscopes with or without pacing pulse indicators
centrifugation of blood for transfusion or auto transfusion
chest retractors for cardiac surgery
dental hand pieces
temporarily store and transport of organs for transplant
diagnostic ultrasound
drills
electrical acupuncture
electroencephalographs
electronic thermometers
evoked response stimulators
external bone growth stimulators
feeding pumps
fissures sealants
fixed dental prostheses
heat and moisture exchangers
heat exchangers
hydrogel dressings
hypodermic needles and syringes
infusion cannulae
jet injectors for vaccination
nasopharyngeal airways
perineal reduction devices
polymer film dressings
positron emission tomography
powered nasal irrigators
pulp testers
removal of carbon dioxide from the blood and/or adding oxygen
single photon emission computer tomography
skin closure devices or temporary filling materials
sperm and human embryos
stents
suckers
suction catheters or tubes for stomach drainage
surgical gloves
surgical swabs
TENS devices
tracheal tubes
urinary catheters
vaginal pessaries
adhesives for topical use
bridges
clamps
crowns
cryosurgery equipment
dental adhesives used for root canal therapy
dentine adhesives
electrocardiographs
gamma cameras
hard contact lenses
hearing aids
magnetic and electromagnetic energy muscle stimulators
magnetic resonance equipment
non-medicated impregnated gauze dressings
orthodontic wire
oxygen tubing and masks; anaesthetic tubing and breathing circuits
particulate filtration of blood in an extracorporeal circulation system
phototherapy for skin treatment and for neonatal care
powered dermatomes
some surgical retractors for example
sterilizers specifically intended to sterilize medical devices
suction equipment
suture needles
syringes and tubing for infusion pumps
tracheostomy tubes connected to a ventilator
Tubes for blood transfusion
Washers-disinfectors intended specifically for disinfecting non-invasive medical devices
long-term storage of biological substances and tissues such as corneas