Sterile medical devices implanted into human tissue, di […]
Sterile medical devices implanted into human tissue, directly or indirectly connected with blood, bone marrow cavity, or unnatural cavity, or single-package factory-made accessories, the processing (non-cleaning) of components, unclean cleaning, assembly, initial The production areas such as packaging and sealing should be no less than 100,000 cleanliness. Such as: pacemaker, percutaneous drainage tube (apparatus), blood separation or filter, single-use sterile syringe, single-use sterile infusion set, single-use sterile blood transfusion device, bone plate bone nail, joint Prostheses, bone cement, etc.
The processing, unfinished cleaning, assembling, primary packaging and sealing of sterile medical devices or single-packed (not cleaned) parts that come into contact with the injured surface and mucous membranes of the human body should be in a clean room of not less than 300,000 get on. Such as: sterile dressings, natural-cavity catheters, tracheal intubation, sterile storage devices and other devices called sterile. The environment required for the processing, final fine cleaning, assembly, primary packaging and sealing of aseptic implantable medical devices or single-package factory-excluded (non-cleaning) parts that come in contact with the surface of the human body is subject to necessary verification and confirmation.
Aseptic medical devices (including medical materials) that are required or processed using aseptic processing technology should be produced in a local hundred-level clean room (area) below the 10,000 level. Such as: sodium hyaluronate gel and so on.
The primary packaging materials that are in direct contact with the used surface of the sterile medical device and are used without cleaning should be set after the verification of the cleanliness level of the production environment. It is advisable to follow the same principles as the cleanliness level of the product production environment. The quality of the packaging material meets the requirements of the packaged sterile medical device. If the primary packaging material does not directly contact the surface of the sterile medical device, it should be produced in a clean room (area) of not less than 300,000. Packaging materials that come into direct contact with the use surface of sterile implantable medical devices and are used without cleaning should take measures to ensure that the packaging materials meet the corresponding cleanliness and sterility requirements and have been verified. The direct contact surfaces of medical devices should be produced in no less than 300,000 clean rooms (areas).
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