In order to ensure the supply of emergency medical disposable protective clothing during the epidemic prevention and control period and ensure the quality, safety and controllability, the Medical Materials Guarantee Group of the Joint Prevention and Control Mechanism of the State Council in response to the new coronavirus-infected pneumonia epidemic recently issued The notice requires the industry and information technology departments, drug supervision and administration departments, and health commissions of all provinces, autonomous regions, municipalities directly under the Central Government, and cities under separate state planning to implement the “Emergency Specifications for Radiation Sterilization of Medical Disposable Protective Clothing (Provisional)” during the epidemic period. There are a total of The four specific measures are temporary emergency measures for epidemic prevention and control and will be lifted automatically after the epidemic is over.
The Medical Materials Guarantee Group of the Joint Prevention and Control Mechanism of the State Council in response to the new coronavirus-infected pneumonia epidemic will implement the “Medical Single Use” during the epidemic. Notice of “Emergency Specifications for Radiation Sterilization of Sexually Protective Clothing (Provisional)”
Pneumonia Mechanism Medical Security Issue [2020] No. 112
Provinces, autonomous regions, and municipalities directly under the Central Government And the industry and information technology departments, drug regulatory departments, and health commissions of cities under separate state planning:
In order to ensure the supply of emergency medical disposable protective clothing during epidemic prevention and control and ensure quality, safety and controllability, the State Council Under the joint prevention and control working mechanism to deal with the pneumonia epidemic caused by the new coronavirus infection, the Ministry of Industry and Information Technology, the State Food and Drug Administration, and the National Health Commission conducted research. After organizing expert deliberation, the National Technical Committee for Standardization of Disinfection Equipment and the National Bioprotection Products The focal point for standardization voted to adopt the “Emergency Specifications for Radiation Sterilization of Medical Disposable Protective Clothing (Provisional)”. The relevant matters are now notified as follows:
1. All localities can adopt the “Emergency Specifications for Radiation Sterilization of Medical Disposable Protective Clothing (Temporary)” (see Attachment 1, hereinafter referred to as the “Emergency Specifications”). Medical protective clothing is sterilized by irradiation (cobalt 60 or electron accelerator) and meets the release conditions in Chapter 4 of the “Emergency Specifications”, and is determined to be qualified medical disposable protective clothing.
2. Institutions with corresponding inspection and testing qualifications shall conduct inspections of medical disposable protective clothing sterilized by radiation in accordance with the requirements of the “Emergency Specifications for Radiation Sterilization of Medical Disposable Protective Clothing (Provisional)”. Test the three major indicators of product performance (one test), rapid detection of biological indicators (one test), and radiation absorbed dose (test for each sterilization batch) and issue test reports.
3. Enterprises that use radiation sterilization to produce medical disposable protective clothing should affix special labels (see attachment 2) on the outer packaging of each medical protective clothing and provide testing that meets product release requirements. Report and ensure that each product meets the requirements of the “Emergency Specifications” and related quality standards. When providing radiation sterilization services, irradiation companies should affix irradiation labels (including: irradiation company name, irradiation date, irradiation batch number and other information) at designated locations on the outer packaging box.
4. When receiving and using emergency medical disposable protective clothing, medical supplies distribution agencies and medical institutions should pay attention to checking the test reports, special markings and irradiation labels, and ensure that they are Only emergency medical disposable protective clothing within the validity period can be used in severe isolation and protection wards (rooms).
The above measures are temporary emergency measures for epidemic prevention and control and will be lifted automatically after the epidemic is over.
Attachment:
1. Emergency specifications for radiation sterilization of medical disposable protective clothing (temporary)
2. Labeling instructions
Ministry of Industry and Information Technology
National Medical Products Administration
National Health Commission
February 7, 2020
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