For sterile and implantable medical devices, what princ […]
For sterile and implantable medical devices, what principles should be followed when setting up a laboratory?
Local sterility test rooms, microbiological limit rooms and positive control rooms (including the flow of people and logistics are relatively independent) should be established separately under the 10,000 level.
Can sterile and implantable medical device manufacturers make parameter releases for their products?
For sterile, implantable medical device manufacturers that have the ability to sterilize their products, the factory inspection items stipulate that the products should be sterilized and can be performed in accordance with the regulations. On the basis of scientific verification of the bacterial process, the detection of bacterial chips can be adopted for product release.
What are the requirements for the production environment of common sterile and implantable medical device products?
(1) The production environment for single-use intravenous needles should be 100,000; the production environment for intravenous indwelling catheters should be 10,000; the production environment for contact lenses (contact lenses) is at least 300,000, and for contact lenses (contact lenses) Production processes such as filling of care liquids should be performed at least in a local environment of 10,000 levels; for products without pyrogen (or endotoxin) and particulate requirements, such as medical masks, medical latex gloves and other products, the production environment is at least 30 Ten thousand.
(2) Staplers (nails) should be implemented according to the appendix of implantable medical devices; embolic agents should be implemented according to the appendix of implantable medical devices; artificial skin should be implemented according to the appendix of implantable medical devices; absorbable materials should be implemented according to implantability Medical device appendix implementation; contact lens (contact lens), contact lens (contact lens) care solution products should be implemented in accordance with the sterile medical device appendix.
(3) Sterile medical devices implanted and intervened in blood vessels and parts that require subsequent processing (such as filling and sealing) in a local hundred-level clean room under the level of 10,000, or single-package factory-made accessories, which are not cleaned The production area of parts processing, final cleaning, assembly, primary packaging and sealing should not be less than 10,000 cleanliness. Such as: intravascular stent, occluder, pacing electrode, artificial blood vessel, intravascular catheter, stent delivery system, etc.
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