How to define sterile medical devices and implantable medical devices

***** sterile medical device refers to the final state of the product to provide sterile devices, there are more kinds of la, there is the use of aseptic processing technology for the manufacture of the product, but also after ethylene oxide sterilization, irradiation sterilization, etc. to get the final sterile products (general manufacturers commonly used EO ethylene oxide sterilization, γ-ray GAMMA irradiation sterilization, medical structure of the hospital is commonly used in STEAM high temperature steam sterilization, small EO sterilizer, PLASMA plasma sterilization, formaldehyde sterilization, and so on). (Generally, manufacturers use EO ethylene oxide sterilization, gamma ray GAMMA irradiation sterilization, medical structure of hospitals and other commonly used STEAM high temperature steam sterilization, small EO sterilizers, plasma sterilization, formaldehyde sterilization, etc.) Such as gauze, surgical gowns, cavity towels, medical catheters, artificial joints, probes high-frequency surgical electrosurgical pens, balloon stents, etc. (basic implanted are sterile)

***** implantable medical devices: surgical means to insert in whole or in part into the human body or natural cavities or to replace the upper epidermis or the surface of the eye, and to survive in the body for at least 30 days, and can only be removed by surgical or medical means. Such as: bone nails, bone plates, artificial organs, cardiac stents, artificial joints, pacemakers, etc. (In general, there are two categories, one is passive implantable devices, including bone and joint replacements, cardiovascular implants, artificial heart valves, breast implants, intraocular crystalline implants, vascular scaffolds, artificial organs, and so on; the other is active implantable devices. (Including implantable cardiac pacemakers, implantable cochlear implants, implantable neurostimulators, implantable electromechanical cardiac circulatory systems, etc.)

-Distinguishable from interventional devices oh ---- interventional medical devices: inserted into the human body or natural cavities by surgical means, for a short period of time for the treatment or examination, the treatment or examination is completed that is removed. Such as: angiography catheter, balloon dilatation catheter, central venous catheter, arterial venous pressure measurement catheter, disposable interventional therapy instrument probe. -----

Generally interventional Implanted is also basically sterile!