GB 15980-1995Hygienic standard of disinfection for single use medical products (English PDF)

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.

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

6 Supervision and inspection management

7 Product package marks

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.