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.
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
|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|
|evoked response stimulators|
|external bone growth stimulators|
|fixed dental prostheses|
|heat and moisture exchangers|
|hypodermic needles and syringes|
|jet injectors for vaccination|
|perineal reduction devices|
|polymer film dressings|
|positron emission tomography|
|powered nasal irrigators|
|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|
|suction catheters or tubes for stomach drainage|
|adhesives for topical use|
|dental adhesives used for root canal therapy|
|hard contact lenses|
|magnetic and electromagnetic energy muscle stimulators|
|magnetic resonance equipment|
|non-medicated impregnated gauze dressings|
|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|
|some surgical retractors for example|
|sterilizers specifically intended to sterilize medical devices|
|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|