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1 Translated English of Chinese Standard GB Translated by: ICS C 59 National Standard of the People s Republic of China GB Hygienic standard of disinfection for single use medical products Issued on: January 23, 1996 Implemented on: July 1, 1996 Issued by: Sate Technical Supervision Bureau; and Ministry of Health. Page 1 of 17

2 Table of Contents 1 Subject content and scope Normative references Terms Sterilization and disinfection standards Production hygiene requirements Supervision and inspection management Product package marks Test methods... 8 Annex A... 9 Annex B Annex C Annex D Annex E Annex F Annex G Page 2 of 17

3 National Standard of the People s Republic of China Hygienic standard of disinfection for single use medical products This Standard is specially formulated according to "Infectious Disease Prevention Act of the People's Republic of China" and "Implementation Methods for Infectious Disease Prevention Act of the People's Republic of China". 1 Subject content and scope This Standard specifies the single use medical products hygiene standards, before and after sterilization and disinfection. This Standard provides the quality control of hygiene requirements to the manufacturing process such as manufacturing, assembly, packaging workshop, and manufacturing workers hands in manufacturing enterprises of single use medical products (including sterilized and disinfected single use medical products). This Standard applies to manufacturing enterprises of all types of single use medical products. And it also applies to sterilization and disinfection service organizations. 2 Normative references GB Standard methods of microbiological examination for cosmetics - Standard plate count GB 8368 Medical infusion sets for single use GB 8369 Transfusion sets for single use GBJ 4883 Standards for sewage drainage in hospitals (Trial) Pharmacopoeia of the People's Republic of China (1990 Edition) 3 Terms 3.1 Sterilization: USE physical or chemical methods to kill all microorganisms on the Page 3 of 17

4 4.4.1 Evaluation criteria of sterilization effects: Ethylene oxide sterilization: USE Bacillus subtilis var.niger (ATCC9372) as indicator bacteria, the inactivation index reaches Ionizing radiation sterilization: USE Bacillus pumilus E601 (ATCC27142) as indicator bacteria, the inactivation index reaches Sterilized by other methods: the inactivation index of indicator bacteria used reaches Evaluation criteria of disinfection effects: Ethylene oxide sterilization: USE Bacillus subtilis var.niger (ATCC9372) as indicator bacteria, the inactivation index reaches Ionizing radiation disinfection: USE Bacillus pumilus E601 (ATCC27142) as indicator bacteria, the inactivation index reaches Disinfected by other methods: the inactivation index of indicator bacteria used reaches Abnormal toxicity, pyrogen, and hemolytic reaction tests of products shall be conducted according to the specifications of GB 8368, Requirements for sterilization and disinfection quality control: It shall formulate the working systems, sterilization or disinfection procedures, and technical parameters according to business requirements of the organization. Records of each-time operating conditions, inspection procedures, and results must be made, and be placed in files for future reference Manufacturing enterprises and sterilization and disinfection service organizations shall set up the quality control room. It must use biological indicators to detect after sterilization and disinfection. It shall re-sterilization or re-disinfection if unqualified products are found, until it complies with 4.4 evaluation criteria of sterilization and disinfection effects. 5 Production hygiene requirements 5.1 Hygiene requirements for plant The plant shall be located at more than 500 meters away from main roads, docks, garages, and other serious air and water polluted areas. The surrounding environment shall be clean and green to prevent dust. Plants in manufacturing areas shall meet Four Nos - no water, no weeds, no garbage, and no mosquitoes breeding Page 5 of 17

5 grounds Factory layout shall be rational. Manufacturing area and administrative office area shall be separated. Manufacturing area shall be located in the upwind side of the main wind direction Water quality of cleaning water shall comply with the standards of injection water in Pharmacopoeia of the People's Republic of China (1990 Edition) Sewage discharging shall comply with GBJ Hygiene requirements for manufacturing workshops Layout of workshops shall comply with the manufacturing process. Parts manufacturing, assembly, packaging, transportation, etc. shall not be reversed and cross. Raw materials transported-in and products transported-out shall have strict regulations. Disinfected or sterilized items and non-disinfected or unsterilized items must be placed and transported separately The interior decoration shall use easy-to-clean, disinfection-resistant, and no-particle-shedding materials. Ground, wall, ceiling, and other surfaces shall be smooth, no cracks, and no dust. And INSTALL adequate low ozone ultraviolet light (30W/10m 2 ) to conduct air disinfection Before entering the assembly, cutting, and packaging workshops, it shall change clean shoes, hats, overalls, and wearing masks. Clean and disinfect hands in the buffer chamber. Buffer chamber shall be divided into polluted area and clean area, which shall have clear signs. It shall set up indoor flush toilets Manufacturing workshop (control area) of sterilized products shall reach grade purification standard, and shall be equipped with air purification system. It shall be equipped with air shower, shower and disinfection facilities. Manufacturing workshop of disinfected products requires clean conditions, and shall have ventilation and dust-prevent equipment. They shall all prevent the flies, mosquitoes, cockroaches, and rats; and prevent foreign substances, etc. from mixing into equipment Products produced shall be packaged timely. Means of transport shall be dedicated. Products packaged shall be stored at a non-corrosive-gas, well ventilated clean room with relative humidity less than 80% The concentration or amount of toxic and hazardous substances generated during the manufacturing shall comply with the relevant national standards. 5.3 Hygiene requirements for production personnel Personnel engaging in production and disinfection and sterilization must have an annual medical examination before being on the job. Patients with active Page 6 of 17

6 Annex G Test method of the amount of ethylene oxide residues in products (Supplement) G1 Test purposes It is to determine the enabled time of products after disinfection. When there are changes in raw materials and disinfection process of products, it shall be tested. G2 Sample collection After ethylene oxide is sterilized, immediately SELECT a certain amount of samples in small package from three large packages in the same disinfection batch randomly. The sampling amount shall be at least enough for 2-time measurements. CONDUCT residual amount determination after ethylene oxide is sterilized for 24h, and every few days after that respectively. It is determined qualified until the residual amount falls under the standard value specified in 4.2. G3 Operating conditions of instruments Instruments: gas chromatograph, hydrogen flame detector. Operating conditions: Column: Chromosorb W, HP, 80-mesh; length of glass column is 2m, diameter is 3mm. Column temperature: 120 C. Detector: 150 C. Gasification: 150 C. Amount of carrier gas: Nitrogen: 35mL/min; Hydrogen: 135mL/min; Air: 350mL/min. Column pre-pressure: 108kPa. G4 Operating steps G4.1 Standard preparation Page 15 of 17

YY Translated English of Chinese Standard: YY

YY Translated English of Chinese Standard: YY Translated English of Chinese Standard: YY0497-2005 www.chinesestandard.net Sales@ChineseStandard.net YY ICS 11.040.20 C 31 Pharmaceutical National Standard of the People s Republic of China YY 0497-2005