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Requirements for clean room cleanliness for various types of medical devices
Requirements for clean room cleanliness for various types of medical devicesI. Implanted and intervened into the blood vessels and the need for subsequent processing (such as filling and sealing, etc.) of sterile medical devices or single-package factory fittings under the level of 10000 in the local class 100 clean area, with the (not clean) parts processing, the end of the road cleaning, assembling, packaging and sealing and other production areas should not be less than 10,000 levels of cleanliness level.Such as: 1. Implanted blood vessels: such as vascular stents, heart valves, and artificial blood vessels. 2. Interventional vascular: all kinds of intravascular catheters, such as central venous catheters, stent delivery systems, etc. II. Implanted into human tissue, and blood, bone marrow cavity, or non-natural lumen direct or indirect access to sterile medical devices or single-package factory fittings, with (not clean) parts processing, end-of-path cleaning, assembly, initial packaging and its sealing and other production areas should be not less than 100,000 class cleanliness level. Such as: 1. Implantation of human tissue devices: pacemaker, subcutaneous implantation of drug delivery devices, etc. 2. Devices in direct contact with blood: plasma separator, blood filter, surgical gloves, etc. 3. Devices in indirect contact with blood: infusion sets, blood transfusion sets, intravenous needles, vacuum blood collection tubes, and so on. 4. Bone contact instruments: intraosseous instruments, artificial bone, etc. III. With the human body damage to the surface and mucous membrane contact of sterile medical devices or single-package factory (without cleaning) parts of the processing, end-of-the-road cleaning, assembly, packaging, and sealing of the initial should be not less than 300000 clean room (area). Such as: 1. Contact with damaged surfaces: burn or trauma dressings, medical degreasing cotton, degreasing gauze, single-use sterile surgical supplies such as surgical pads, surgical gowns, medical masks, and so on. 2. Contact with mucous membranes: sterile urinary catheters, tracheal intubation, intrauterine devices, human lubricants, etc. IV. Direct contact with the use of sterile medical equipment surface, not cleaned that is used in the initial packaging materials, the production of environmental cleanliness level should be set up to follow the same principle as the cleanliness level of the production environment, so that the quality of the initial packaging materials to meet the requirements of the packaging of sterile medical devices, if the initial packaging materials are not in direct contact with the surface of the use of sterile medical equipment should be in not less than 300000 clean room (area). Production. Such as: 1. Direct contact: such as primary packaging materials for drug delivery devices, artificial breasts, urinary catheters, etc. 2. No direct contact: such as infusion sets, blood transfusion sets, syringes, and other primary packaging materials. V. For sterile medical devices (including medical materials) that have requirements or are processed using aseptic operation techniques, they should be produced in a local class 100 clean room (area) under class 10000. Such as: 1. such as blood bag production of anticoagulants, maintenance fluid filling, aseptic preparation, and filling of liquid products. 2. Pressure grip and coating of vascular stents. |
