GB 15980-1995 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 15980-1995 | English | 70 |
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Hygienic standard of disinfection for single use medical products
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GB 15980-1995: Hygienic standard of disinfection for single use medical products---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB15980-1995
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
media, so as to make them sterile.
3.2 Disinfection. USE physical or chemical methods to kill or clear all pathogenic
microorganisms on the media, so as to make them harmless.
3.3 Sterilized single use medical products. The single use medical products that enter
into the body tissues; that are sterile, non-pyrogenic, non-hemolytic reactions, without
abnormal toxicity; that have been inspected to be conformance; that must be sterilized
before exiting out of the factory; and that can be used directly.
4 Sterilization and disinfection standards
4.1 Single use medical products must be sterilized and disinfected by ethylene oxide,
ionizing radiation or other methods that have are determined qualified by Ministry of
Health. All sterilization and disinfection equipment used must have a product license
and hygiene license.
4.2 When single use medical products exit the factory after being sterilized or
disinfected by ethylene oxide, the ethylene oxide residues shall be not more than
10μg/g.
4.3 Microbial indicators of sterilization and disinfection.
4.4 Evaluation criteria of sterilization and disinfection effects.
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.
4.4.2.4 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.
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.
5.2 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.
5.2.5 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
tuberculosis, viral hepatitis, dysentery, typhoid fever or chronic carriers, gonorrhea
and purulent or exudative dermatitis must not engage in this work.
6 Supervision and inspection management
6.1 Manufacturing enterprises must have the test equipment and measurement
instruments that guarantee product quality, and set up quality control room.
6.2 Requirements for self-test of manufacturing enterprises.
6.2.2 At the key operating points of workshop (control area), CONDUCT one-time
total bacteria number detection for the air, objects’ surfaces, and manufacturing
workers’ hands every week.
6.2.3 For each batch of products, SELECT randomly 10 pieces of samples to conduct
initial contaminating bacteria number AND sterile detection of after-sterilization OR
bacteria number detection after disinfected.
7 Product package marks
7.1 Each set of products shall be packaged and sealed in plastic bags. It shall have
the following marks on small packages.
7.2 Middle package shall be sealed by plastic bags, and shall have the following
marks.
7.3 It shall have the following marks on large packing cases.
8 Test methods
REFER to Annex A~G.
Annex A
Detection method of the total number of bacteria in the air
(Supplement)
A1 DETERMINE the total number of bacteria in the air in dynamic state.
A2 USE plate exposure method. For the workshops larger than 30m2, at five points of
east, west, south, north, and center (1m away from the wall). For the workshops less
than 30m2, at three points of inside, middle, and outside of a diagonal line. Sampling
height is at 1.5m. PLACE ordinary nutrient agar plates (diameter of 9cm) according to
the above sampling points and height. CLOSE the lid immediately after exposing for
15min. OBSERVE the result after cultured at 37°C incubator for 24h. WORK OUT the
average number of bacteria of 5 or 3 sampling points. The calculation formula is
shown in Formula (A1).
Annex B
Detection method of the total amount of bacteria on object surfaces and
manufacturing personnel’s hands
(Supplement)
B1 Sampling method
PUT the sterilization specification-plate with the inner diameter of 5cm×5cm ONTO
the surface of objects to be tested. TAKE 1~4 parallel samples according to the
surface area of objects. USE cotton swabs with sterile normal saline, to smear 10
times on the specification-plate (a round-trip is counted as 1). PUT the cotton swabs
into the 10 mL sampling tube of sterile normal saline. Conduct sampling on
manufacturing personnel’s hands. fingers of person to be detected shall be close
together. USE cotton swabs with sterile normal saline to smear 10 times
back-and-forth from the fingertips, to nail groove then to finger root on the surface of
right hand’s fingers. then PUT the cotton swabs into the 10 mL sampling tube of sterile
normal saline.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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