Technical requirements for the hygiene and safety evaluation of disinfectant products
1 Scope
This standard specifies the basic requirements and contents of hygiene and safety evaluation of disinfectant product.
This standard is applicable to the hygiene and safety evaluation of classes I and II disinfectant products (disinfectants, disinfection instruments, indicators and antibacterial (bacteriostatic) preparations) produced, managed and used within the territory of the People's Republic of China, except new disinfectant products.
This standard is not applicable to the hygiene and safety evaluation of customized disinfection instruments.
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.
Standard for hygiene and safety evaluation of disinfectants and disinfection facilities for drinking water (trial) (Edition 2005) issued by the Ministry of Health of the People's Republic of China (WEIJIANDUFA [2005] No.336)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
hygiene and safety evaluation of disinfectant product
comprehensive evaluation on the effectiveness, hygiene and safety of disinfectant products, including product labels (nameplates), instructions, inspection reports, enterprise standards or quality standards, hygiene licenses of manufacturers (documents proving that production and sales are allowed overseas and customs declarations), as well as product formulas of disinfectants, indicators and antibacterial (bacteriostatic) preparations, and structural diagrams of disinfection instruments
3.2
responsible entity
individuals, legal persons and other organizations that are liable for compensation for personal injury or property losses caused by product defects in accordance with the law; it refers in particular to the entrusting party where the production and processing are entrusted; and it refers to the responsible entity in China for imported products
3.3
class I disinfectant product
high-level disinfectants and disinfection instruments, sterilizing agents and sterilization instruments for medical devices, as well as skin & mucosal disinfectants, biological indicators and chemical indicators for sterilization effect
3.4
class II disinfectant product
disinfectants, disinfection instruments and chemical indicators other than class I disinfectant products, as well as sterilization article packaging with sterilization identification and antibacterial (bacteriostatic) preparations
3.5
customized disinfection instrument
non-approved disinfection instruments designed and manufactured for a single project and not mass-produced