GB 15980-1995 English PDF (GB15980-1995)

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GB 15980-1995: Hygienic standard of disinfection for single use medical products
GB 15980-1995
GB
ICS 11.120.20
C 59
National Standard
of the People’s 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’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 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 steriliz...