Original Title: Relevant Requirements for Clean Workshops for Medical Device Production Relevant requirements for clean workshop of medical device production The Detailed Rules for the Implementation of the Production of In Vitro Diagnostic Reagents (Trial) (GSYJX [2007] No.239) has been implemented since 2007, and the Good Manufacturing Practice for Sterile and Implantable Medical Devices has been implemented since 2011. Announcement No.64 of 2014, the State Administration revised the Good Manufacturing Practice for Medical Devices in July 2015. The General Administration of the People's Republic of China has successively issued the Announcement on Issuing the Appendices to the Quality Management Standards for Medical Device Production for In Vitro Diagnostic Reagents, the Announcement on Issuing the Appendices to the Quality Management Standards for Medical Device Production for Sterile Medical Devices, and the Announcement on Publishing the Appendix to the Standards for Quality Management of Medical Devices Production for Implantable Medical Devices. To further strengthen the production quality requirements of aseptic, implantable and in vitro diagnostic reagents, in the daily supervision process, it is found that the construction of clean delivery rooms in some enterprises is not standardized enough. Therefore, the construction requirements of the clean plant are as follows: I. Standards and working papers currently covered 1. YY 0033-2000 Production Management Specification for Sterile Medical Devices; 2. YY/T 0567.1-2013 Aseptic Processing of Medical Products Part 1: General Requirements; 3. YY/T 0567.2-2005 Aseptic Processing of Medical Products-Part 2: Filtration; 4. GB 50457-2008 Code for Design of Clean Room in Pharmaceutical Industry; 5. Appendix A of the Detailed Rules for the Production of In Vitro Diagnostic Reagents (Trial); 6. Announcement on Issuing the Appendix of Good Manufacturing Practice for Medical Devices Sterile Medical Devices (No.101 of 2015); 7. Announcement on Issuing the Appendix to the Good Manufacturing Practice for Medical Devices Implantable Medical Devices (No.102 of 2015); 8. tailed Rules for the Implementation of the Production of IVD Reagents (Trial). The treatment of negative and positive serum, plasmids or blood products shall be carried out in an environment of at least 10,000 levels, with a relative negative pressure maintained in the adjacent area, and shall meet the protection requirements. 7. The direction of air return, and shall be 20 ~ 24 ,Medical Full Body Coverall, and the relative humidity shall be 45% ~ 65%; the temperature of the clean room (area) with air cleanliness of one hundred thousand and three hundred thousand shall be 18 ~ 26 , and the relative humidity shall be 45% ~ 65%. If there are special requirements, they shall be determined according to the process requirements. 3. The temperature of the personnel purification room shall be 16 ~ 20 in winter and 26 ~ 30 in summer. V. Commonly used monitoring equipment Anemometer, dust particle counter, temperature and humidity meter, differential pressure meter, etc. VI. Requirements for Sterile Testing Room The clean plant must be equipped with a sterile testing room (seprence, ventilation rate, dust count and settling bacteria. 2. The parts to be tested include: (1) Production workshop: personnel purification room; material purification room; buffer area; rooms required by the product process; cleaning room for station appliances, sanitary ware room, Medical Full Body Coverall ,Virus Prevention Mask 3 Ply with Earloop, laundry room, temporary storage room, etc. (2) Sterile testing room. VIII. Requirements for Catalogue of Medical Devices Produced in Clean Workshop For the sterile medical devices implanted or inserted into the blood vessel and the aironment. The environment's air supply, materials, equipment, and personnel are controlled to maintain acceptable levels of microbial and particulate contamination. Sterile medical device: refers to any medical device marked with "sterile". Note: The clean workshop must include a sanitary ware room,KN95 Mask for Epidemic Prevention and Control, a laundry room, a temporary storage room, and a cleaning room for station tools. Products produced under purification conditions: refer to the products that are required to be sterile or sterilized at the time of final use. Source Medical Equipment Industry Information Return to Sohu to see more Responsible Editor:. zjyuan-group.comd env