This standard is developed hereby in accordance with Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases and Measures for Implementation of the Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases.
1 Subject Content and Application Scope
This standard specifies the hygienic standard of single use medical products before and after sterilization and disinfection. This standard proposes the quality control required by the hygiene for the production, assembly, packaging workshop and other production processes and production worker's hands of single use medical product (including sterilized and disinfected ones) manufacturer.
This standard is applicable to the manufacturers of various single use medical products and is also applicable to sterilization and disinfection service organizations.
2 Normative References
GB 7918.2 Standard Methods of Microbiological Examination for Cosmetics
GB 8368 Infusion Sets for Single Use
GB 8369 Transfusion Sets for Single Use
GBJ 4883 Standards for Sewage Drainage in Hospitals (Trial)
Pharmacopoeia of People's Republic of China (Edition 1990)
3 Terms and Definitions
3.1 sterilization: process of killing all the microorganisms on the vector of transmission with physical or chemical methods to be sterile
3.2 disinfection: process of killing or clearing the pathogenic microorganism on vector of transmission with physical or chemical method to be sterile
1 Subject Content and Application Scope
2 Normative References
3 Terms and Definitions
4 Sterilization and Disinfection Standards
5 Hygienic Requirements of Production
6 Supervision and Inspection Management
7 Product Package Mark
8 Test Methods
Annex A Test Methods of Total Bacterial Count in the Air (Supplement)
Annex B Test Methods of Total Bacterial Count on the Object Surface and Production Personnel's Hands (Supplement)
Annex C Test of Initial Contaminating Bacteria Count (Supplement)
Annex D Sterile Test Method (Supplement)
Annex E Test Method of Sterilization or Disinfection by Ionizing Radiation (Supplement)
Annex F Test of Sterilization or Disinfection Effect by Ethylene Oxide (Supplement)
Annex G Test Method for Ethylene Oxide Residual Quantity of Product (Supplement)
Additional Explanations:
