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Scope of application of ISO13485 certification
Time:2022-03-24 Clicks:

1. General medical devices


2. Active implantable medical devices are medically or surgically


A medical device that implants all or part of an active medical device into the human body or inserts it into the natural hole of the human body by means of medical methods, and indwells it in the human body.


3. Active medical devices


device) is a medical device that cannot be driven only by the human body or gravity, but by electrical energy or power energy.


4. Implantable medical device (implantable medical device) as a medical device used in the following conditions


The device is to be implanted in whole or in part into the human body or the natural orifice of the human body The device itself replaces the surface of the skin or the surface of the eye


Such devices must be surgically implanted in the human body and remain in the human body for at least 30 days, and when removed from the human body, only by medical or surgical procedures.


5. Sterilized medical devices refer to medical devices that are intended to meet sterilization requirements.