Rule No.

Description

Class

Rule 1

Either do not touch patient or contact only intact skin.

Class I

Rule 2

Channeling or storing for eventual administration

unless;

Class I

- for use with blood, other body fluids, organs, tissues

or;  

Class IIa

- may be connected to an active medical devices.

Class IIa

Rule 3

Modify biological or chemical composition of blood,

body fluids, other liquids unless;

Class IIb

-Only filtration, centrifugation or exchange of gas or heat

Class IIa

Rule 4

Contact with injured skin (mechanical barrier – absorb

exudates) unless;

Class I 

- intended for wounds which breach dermis and heal

only by secondary intent or;

Class IIb

- intended to manage micro-environment of wound +

toehrs

Class IIa

Rule 5

Invasive in body orifice or stoma (not surgically) for

transient use

Class I

Invasive in body orifice or stoma (not surgically) for short time use

* If only in oral cavity, ear canal or nasal cavity

Class IIa

Class I

Invasive in body orifice or stoma (not surgically) for long time use    * If only in oral cavity, ear canal or nasal cavity

Class IIb

Rule 6

Surgically invasive – Transient use

* Diagnose/Control – Defect of heart/Central circulation system

* Reusable surgical instrument

* Supply energy/Ionizing radiation

* Biological effect –mainly absorbed

* System to administer medicines/Potentially hazardous

Class IIa

Class III

Class I

Class IIb

Class IIb

Class IIb

Rule 7

Surgically invasive – Short term use

* specifically to monitor/correct defect of heart or central

circulation system by direct contact

* for use in direct contact with central nervous system

* Supply energy/Ionizing radiation

* Biological effect – mainly absorbed

* undergo chemical change in body – or administer

medicines   (not in teeth)

Class IIa

Class III

Class III

Class IIb

Class III

Class IIb

Rule 8

Surgically invasive – Long term use

* To be placed in teeth

* Used in direct contact with heart circulatory system /nervous system

* Biological effect – mainly absorbed

* undergo chemical change in body – or administer

medicines (not in teeth)

Class IIb

Class IIa

Class III

Class III

Class IIb

Rule 9

Active therapeutic devices intended to administer or

exchange energy unless;

Class IIa

- administer or exchange energy in potentially

hazardous way or;

Class IIb

- intended to control and monitor or influence directly a

class IIb active therapeutic devices

Class IIb

Rule 10

Active device for diagnosis.

May supply energy, for imaging purpose, monitor vital

physiological processes unless;

Class IIa

- when used to monitor vital processes where variations

could result in immediate danger or;

Class IIb

- SPECIAL: all devices emitting ionizing radiation and

related monitors in medical procedure

Class IIb

Rule 11

Active devices to administer and remove medicines and

other substances to or from the body unless;

Class IIa

- if this is in a potentially hazardous way

Class IIb

Rule 12

All other active devices

Class I

Rule 13

Devices incorporating integral medicinal product – liable

to act in ancillary way on human body

Class III

Rule 14

Devices used for contraception or prevention of sexually

transmitted diseases unless;

Class IIb

- If implantable or long-term invasive    

Class III

Rule 15

Specific disinfecting, cleaning, rinsing devices – for contact lenses unless;

Class IIb

- For disinfecting other medical devices other than by

physical action  

Class IIa

Rule 16

Non-active devices to record X-ray diagnostic images

Class IIa

Rule 17

Devices utilizing animal tissues or derivatives (not

devices in contact only with intact skin)

Class III

Rule 18

Blood bags

Class IIb