ISO13485 certification scope

Following the medical device industry can be applied to this certification: 1. General medical equipment; 2. Active Implantable Medical Devices (active implantable medical device) to medical or surgical manner, the active all or part of the medical device, implant human body or by medical method for inserting the body's natural hole, and left in the body of the medical device; 3. Active Medical Devices (active medical device) not only by the human body or gravity, but must be driven by electrical energy or power to drive medical The implantable medical devices (implantable medical device) for use as a medical device following conditions; equipment: equipment in whole or in part to be implanted in the body or the body's natural hole; the equipment itself or to replace the surface of the skin surface of the eye; such equipment must By surgically implanted in the body and remain in the body for at least 30 days, and, when removed from the body, only by medical or surgical whom. 5. sterilized medical devices (sterile medical device) intent to meet the sterilization requirements refer to medical devices.