What should be paid attention to when analyzing the clean area of ​​medical equipment

First, the production technology of sterile medical devices should be used to minimize the pollution to ensure that medical devices are not polluted or can effectively eliminate pollution.

Second, implanted and inserted into the blood vessels and need to be processed in the local 100-level clean area under the 10,000 level (such as filling seals) of sterile medical equipment or single packaging by the factory's accessories, which (not cleaned) zero Processing of parts; final cleaning, assembly, initial packaging and sealing, etc. should be no less than 10,000 cleanliness level.

Third, implanted into human tissue, with or without the blood or unnatural channel, the reactive bridge device or single-package factory accessories, the processing of (not cleaning) parts, the final cleaning, assembly, initial packaging Production areas such as sealing and sealing should be no less than 100000 cleanliness level.

Fourth, the processing of sterile medical equipment or single-package factory (non-cleaning) parts that are in contact with the human body and the mucosa, the final cleaning, assembly, initial packaging and sealing should be no less than 300,000 clean room. get on.

5. Direct contact with the surface of the sterile medical device, the primary packaging material that is not used for cleaning, the setting of the cleanliness level of the production environment should be the same as the cleanliness level of the product production environment, so that the quality of the initial packaging material To meet the requirements of the packaged sterile medical devices, if the initial packaging materials are not in direct contact with the surface of the sterile medical device, it should be produced in a clean room of not less than 300,000.

6. For sterile medical devices (including medical materials) that are required or processed by aseptic technique, they should be produced in a partial 100 clean room under Class 10,000.

Seven, clean overalls cleaning, drying and wearing clean overalls room, the level of cleanliness and disinfection of the special cleaning and disinfection area of ​​the special station equipment can be lower than the level of the production area, the finishing of the sterile work clothes, the storage after the bacteria should be It is necessary to have a Class 10,000 clean area.

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