This standard specifies the raw material requirements, technical requirements, application scope, application methods, packaging, transportation and storage, identification, labels and instructions as well as inspection methods for alcohol-based disinfectants.
This standard is applicable to alcohol-based disinfectants with ethanol and/or isopropanol/n-propanol as sterilization ingredient(s), and ethanol and/or isopropanol/n-propanol disinfectants compatible with surfactant and skin care ingredients.
This standard is not applicable to the ethanol or isopropanol/n-propanol disinfectants compounded with other sterilization ingredients, nor those with ethanol or isopropanol/n-propanol as the solvent.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 27949 Hygienic requirements for medical items disinfection
GB 27950 Hygienic requirements for hand antiseptic agents
GB 27951 Hygiene requirements for skin disinfectant
GB 27952 Hygienic requirements for surface disinfectants
GB 31640 National food safety standard - Edible alcohol
GB/T 38499 Evaluation method for stability of disinfectant
WS 310.2 Central sterile supply department (CSSD) - Part 2: Standard for operating procedure of cleaning, disinfection and sterilization
WS/T 535 Rapid detection methods on site for disinfectant used in medical and health institutions
Pharmacopoeia of the People's Republic of China (Edition 2015)
Technical standard for disinfection (Edition 2002) issued by the Ministry of Health of the People's Republic of China (WEIFAJIANFA [2002] No.282)
Hygienic code for disinfectant product manufacturer (Edition 2009) issued by the Ministry of Health of the People's Republic of China (WEIJIANDUFA [2009] No.53)
3 Terms and definitions
For the purposes of this document, the following term and definition apply.
3.1
alcohol-based disinfectant
disinfectant with ethanol and/or isopropanol/n-propanol as the sterilization ingredient(s)
GB/T 26373-2020 The following standards are cited: