The classification principles of ISO13485 medical devices are mainly based on their characteristics, such as non-invasive devices, invasive devices, active devices, and other special principles. The classification of ISO13485 can be defined according to the guidelines of MDD, 93/42/EECAnnexIX Description, or use the British Department of Health's disk to judge, and it is up to the manufacturer to decide.

Considering the degree of danger that the design and manufacture of ISO13485 medical devices may bring to the human body, medical devices can be divided into the following four categories:

1.Class I low risk (Low risk)

2.Class IIa low to medium risk (Lowtomedium risk)

3. Class IIb medium risk (Medium risk)

4.Class III high risk (High risk)

The ISO13485 classification description is as follows:

1.Class I low risk, defined as follows:

a. Non-invasive devices for the delivery, storage or injection of blood, other than body fluids

b. Non-invasive devices in contact with injured skin to stop exudates

c. Temporary use of invasive devices not exceeding 60 minutes

d. Short-term use of invasive devices from mouth to throat, ear tube to eardrum for a short period of not more than 30 minutes

e. Reusable surgical instruments

f. Invasive devices for long-term implantation in teeth

g. Active devices not belonging to Class II

Non-sterile medical equipment, such as: examination gloves, latex gloves for examination, bandages, operating tables, operating lights, prosthetics, wheelchairs, electric scooters, hot and cold packs, medical braces, etc.

Sterilized therapeutic equipment, such as surgical sterilization gloves, knives, OK bandages, etc.

2.Class IIa low to medium risk, defined as follows:

a. Non-invasive devices for delivering, storing or injecting blood and body fluids

b. Directly include filtration, exchange, heat treatment of category IIb (a)

c. Category I(d) devices for long-term use

d. Active therapeutic devices for controlling or exchanging energy

e. An active device for diagnosis that supplies visible light energy for absorption by the human body and displays images of the distribution of radiopharmaceuticals in the body

f. Devices for sterilizing medical use

g. Non-active devices especially for recording X-ray diagnostic images

For example: surgical gloves, various types of catheters for surgery, blood circuit catheters for kidney dialysis, suction devices, infusion sets, emergency breathing equipment, injection syringes with needles, safety syringes, acupuncture needles, scalp needles, ear thermometers, Electronic thermometer, low/medium/high frequency therapy device, infrared electronic therapy device, infrared electronic toothbrush, blood circulation machine, sterilizer, contact lenses...etc.

3. Risk in Class IIb is defined as follows:

a. Non-invasive devices for altering blood, other body fluids or injectable fluids

b. Non-invasive devices for subsequent treatment of torn epidermal wounds

c. Long-term use of invasive devices that provide energy or produce biological effects with ionizing radiation

d. In addition to long-term invasive devices of categories I(f) and III, and active devices with danger (such as electro-radiation)

e. Devices for birth control or prevention of sexually transmitted infections

f. All devices used for disinfection, cleaning and washing of contact lenses

g. blood bag

For example: hemodialyzer, oximeter, electrosurgery device, X-ray machine, ultrasonic spray breathing therapy device, physiological monitor, bone nail, bone plate, artificial joint, condom, blood bag...etc.

4.Class III high risk, defined as follows:

a. Temporary, short-term and long-term invasive devices for diagnostic and monitoring purposes in direct contact with the heart or central circulation and nervous system

b. Invasive devices that produce biological effects in the body, undergo chemical changes or control drugs

c. All devices that contain a medical substance in compliance with Directive 65/65/EEC and which may have an effect on the human body to assist in the medical effect

d. Long-term implantable medical devices

e. Devices made from non-living animal tissue or its derived substances in contact with wounded skin

For example: absorbable surgical suture, joint injection, brain drainage system...etc.

Requirements for ISO13485 technical files

Technical file (Technical Construction File, TCF) requirements in 93/42/EEC

1. A comprehensive description of the product, including any planned changes;

2. Technical drawings, production methods, schematic diagrams of components, circuit diagrams, etc.;

3. The descriptions necessary to understand the above drawings and diagrams, and the descriptions on the working principle of the product;

4. As a result of the hazard analysis of the product, in accordance with the list of all technical standards referred to in Article 5 of the Directive, if the product does not fully meet the listed standards, it must be stated what other measures are taken to ensure full compliance with the Directive's requirements. basic requirements;

5. For sterilization and disinfection products, the method used must be explained;

6. The result of the design check and the result of the relevant inspection. If the product must be used in combination with other products, it must be proved that the basic requirements of the directive can also be met when used in combination with the manufacturer's regulations;

7. Test report, including clinical data if necessary;

8. Product labeling and instructions for use.