Xinhua Beijing January 1 (Xinhuanet Huang Greek) State Food and Drug Administration recently issued a "Medical Device Good Manufacturing Practice Rules for the Implementation sterile medical devices (Trial)" on the health of employees, Workwear Clothing, cleaning, etc. required to make clearly defined.
    According to "Medical Device Manufacturing Practice Rules for the Implementation sterile medical devices (for Trial Implementation)", direct contact with materials and products for operators of medical examinations at least 1 year. Suffering from contagious and infectious diseases shall not engage in direct contact with the work product.
    Rule requirements, manufacturers should develop clean and sterile Workwear Clothing regulations. Clean Workwear Clothing and sterile Workwear Clothing shall not be shedding fibers and particulate materials, sterile overalls should be able to package covered all the hair, beard and feet, and can stay in the body blocking off things.
    Rule also provides that persons entering the clean room (zone) should be decontaminated according to procedures, and wear clean Workwear Clothing, work hats, masks, work shoes. Bare hand contact with the product operator at regular intervals to be disinfected once again opponents.
    "Medical Device Good Manufacturing Practice Rules for the Implementation sterile medical devices (Trial)" Since January 1, 2011 into effect. State Food and Drug Administration "on the issuance of" single-use sterile medical products (Note, transmission equipment) production implementation details "(2001 Amendment) Notice" (State Drug Administration of firearms 〔2001〕 No. 288), and "on the issuance of" Disposable anesthesia puncture package production implementation details "notice" (State Drug Administration of firearms 〔2002〕 472 号) also abolished.