General requirements of disinfectant of medical instruments
1 Scope
This standard specifies the raw material requirements, technical requirements, inspection methods, application methods, identification, packaging, storage and transportation requirements of chemical disinfectants for medical instruments disinfection and sterilization.
This standard is applicable to disinfectant of medical instruments.
This standard is not applicable to disinfection instruments with disinfection factor generating devices and gases as well as disinfection and sterilization products that effect after gasification/vaporization under specific conditions.
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 (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods.
GB 30689 Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
GBZ 2 (all parts) Occupational exposure limits for hazardous agents in the workplace
WS 507 Regulation for cleaning and disinfection technique of flexible endoscope
Technical standard for disinfection (Edition 2002) issued by [the Ministry of Health of the People's Republic of China (WEIFAJIANFA [2002] No.282)]
Technical Specification for Disinfection Effect Inspection of Endoscope Cleaning Disinfector (Trial) [the Ministry of Health of the People's Republic of China (WEIFAJIANFA [2003] No.330)]
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
medical instruments
apparatus, equipment, appliances, materials or other articles used alone or in combination for human body
Note: medical instruments are classified into critical, semi-critical and less critical ones according to the degree of risk of infection during use.
3.2
disinfectant of medical instruments
chemical used for treatment of medical instruments to achieve disinfection or sterilization requirements
4 Requirements for raw materials
4.1 Disinfectant raw materials shall comply with the Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV), corresponding national standards or industry standards and other relevant regulations, and have corresponding qualification certificates.
4.2 Production water shall be deionized water.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for raw materials
5 Technical requirements
6 Inspection methods
7 Application methods
8 Labeling
9 Packaging, storage and transportation
