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GB 15980-1995 English PDF (GB15980-1995)

GB 15980-1995 English PDF (GB15980-1995)

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GB 15980-1995: Hygienic standard of disinfection for single use medical products

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 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.
GB 15980-1995
GB
ICS 11.120.20
C 59
National Standard
of the PEOPLE Republic of China
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.
Table of Contents
1 Subject content and scope ... 3
2 Normative references ... 3
3 Terms ... 3
4 Sterilization and disinfection standards ... 4
5 Production hygiene requirements ... 5
6 Supervision and inspection management ... 7
7 Product package marks ... 7
8 Test methods ... 8
Annex A ... 9
Annex B ... 10
Annex C ... 11
Annex D ... 12
Annex E ... 13
Annex F ... 14
Annex G ... 15
National Standard of the PEOPLE 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 7918.2 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 4.4.1 Evaluation criteria of sterilization effects.
4.4.1.1 Ethylene oxide sterilization. USE Bacillus subtilis var.niger (ATCC9372) as indicator bacteria, the inactivation index reaches 106.
4.4.1.2 Ionizing radiation sterilization. USE Bacillus pumilus E601 (ATCC27142) as indicator bacteria, the inactivation index reaches 106.
4.4.1.3 Sterilized by other methods. the inactivation index of indicator bacteria used reaches 106.
4.4.2 Evaluation criteria of disinfection effects.
4.4.1.1 Ethylene oxide sterilization. USE Bacillus subtilis var.niger (ATCC9372) as indicator bacteria, the inactivation index reaches 103.
4.4.1.2 Ionizing radiation disinfection. USE Bacillus pumilus E601 (ATCC27142) as indicator bacteria, the inactivation index reaches 103.
4.4.2.3 Disinfected by other methods. the inactivation index of indicator bacteria used reaches 103.
4.4.2.4 Abnormal toxicity, pyrogen, and hemolytic reaction tests of products shall be conducted according to the specifications of GB 8368, 8369.
4.5 Requirements for sterilization and disinfection quality control.
4.5.1 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.
4.5.2 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
5.1.1 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 grounds.
5.1.2 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.
5.1.3 Water quality of cleaning water shall comply with the standards of injection water in Pharmacopoeia of the People's Republic of China (1990 Edition).
5.1.4 Sewage discharging shall comply with GBJ 4883.
5.2 Hygiene requirements for manufacturing workshops
5.2.1 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.
5.2.2 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/10m2) to conduct air disinfection.
5.2.3 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.
5.2.4 Manufacturing workshop (control area) of sterilized products shall reach 100000-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. 5.2.5 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%.
5.2.6 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
5.3.1 Personnel engaging in production and disinfection and sterilization must have an annual medical examination before being on the job. Patients with active 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

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