What are the requirements for the production of sterile medical devices?

Mar 30,2023

All aspects of its production, especially the production environment must be strictly required and controlled in order to ensure product quality and prevent the production environment from polluting the product. Therefore, sterile medical devices must be produced in a clean area, and the cleanliness level is set according to the contact between the product and the human body to meet the specified production environment requirements.

The processing, finishing cleaning, assembly, primary packaging and sealing of sterile medical devices or single-packaged (uncleaned) parts that come into contact with human body damaged surfaces and mucous membranes should be performed in a clean room of no less than 300,000 (area) ) within.

1. Contact with damaged surfaces: burn or wound dressings, medical absorbent cotton, absorbent gauze, disposable sterile surgical supplies such as surgical pads, surgical gowns, medical masks, etc.

2. Contact with mucous membrane: sterile catheter, tracheal intubation, intrauterine device, etc.

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