Product Scope
The hygiene and safety evaluation of disinfection product refers to a comprehensive evaluation on product efficacy and hygiene & safety of the non-new Category I and Category II disinfection products, including product label(nameplate), manual, test reports, executive standard (quality standard), product formula (of disinfectant, indicator and antibacterial/bacteriostatic agent) and structural diagram of disinfecting apparatus, as well as necessary documentary evidence. Category I disinfection products are high-level disinfectants and disinfecting apparatus for medical devices, sterilizers and sterilization equipment, skin/mucosal disinfectants, biological indicators, and chemical indicators of sterilization effect and Category II disinfection products are disinfectants, disinfection equipment, chemical indicators, packed-sterilized articles with sterilization marking, and antibacterial (bacteriostatic) agents other than Class I disinfection products. It is important to notice that carrier disinfectants (disinfecting wipes, cotton balls and cotton swabs) boiling sterilizer and milk bottle sterilizer are not yet subject to the evaluation requirements.Evaluation Requirements
Before the place of disinfection products on the market, indigenous manufacturers of homemade products, entrusting parties of OEM products and the Chinese responsible parties of imported products should conduct the evaluation and compile the evaluation report either by themselves or third-party organizations. The test reports and other information need to be incorporated into the “Hygienic Safety Evaluation Report of Disinfection Products” and filed at provincial health authorities. Companies will bear legal liabilities for the authenticity of the filed data as receiving authorities will only check the completeness and appropriateness. Post filing rectification measures would be implemented if inconsistency was identified during the market circulation stage. The test scope, evaluation criteria and report compilation requirements were originally specified in a ministerial regulation, “Rules on the Hygiene and Safety Assessment on Disinfection Products”. In 2019, China regulation, “WS 628-2018 Technical Requirements for the Hygiene and Safety Evaluation of Disinfection Products”, which includes some technical amendments to the ministerial regulation and enacted in parallel with the ministerial regulation.Follow-up Obligations
All Category I products need to be re-evaluated every 4 years and the evaluation of Category II products can be recognized permanently. If the Category II producer alters the production site, opens a new facility or entrusts new OEM factories, prolongs the shelf life of disinfectants, sterilization indicator, packed-sterilized articles with sterilization marking or alter the use scope or application method of disinfectants, disinfecting apparatus and antibacterial (bacteriostatic) agents, the products shall be re-evaluated.Product Executive Standard
Product executive standards include necessary quality requirements of raw material, quality indicators and testing methods of final products. For homemade products, the standard can be an enterprise standard self-declared at the National Enterprise Standard Service Platform. For imported products, the standard refers to the quality standard of the products. In recent 2 years, China promulgated/revised a dozen mandatory or voluntary standards of disinfectants. The voluntary ones can serve as an important reference in preparing an executive standard, but the mandatory ones are the minimum requirements for disinfection products. all executive standards need to comply with the specific requirements in corresponding mandatory standards:| Mandatory | Voluntary |
| GB 27948-2020 General Requirements for Air Disinfectant 空气消毒剂通用要求 | GB26366-2020 Hygienic Standard for Chlorine Dioxide Disinfectant 二氧化氯消毒剂卫生标准 |
| GB 27949-2020 General Requirements of Disinfectant of Medical Instruments 医疗器械消毒剂通用要求 | GB26367-2020 Hygienic Standard for Biguanide Disinfectants 胍类消毒剂卫生标准 |
| GB 27950-2020 General Requirements for Hand Disinfectant 手消毒剂通用要求 | GB26368-2020 Hygienic Standard for Iodine-containing Disinfectants 含碘消毒剂卫生标准 |
| GB27951-2011 Hygiene Requirements for Skin Disinfectant皮肤消毒剂卫生要求 | GB26369-2020 Hygienic Standard for Quaternary Ammonium Disinfectants 季铵盐类消毒剂卫生标准 |
| GB 27952-2020 General Requirements for Ordinary Objects Surface Disinfectant 普通物体表面消毒剂通用要求 | GB26371-2020 Hygienic Requirements for Peroxide Disinfectants 过氧化物类消毒剂卫生标准 |
| GB 27953-2020 General Requirements on Disinfectant for Infectious Focus 疫源地消毒剂通用要求 | GB26370-2020 Hygienic Requirements for Hypobromous Acid Disinfectants 含溴消毒剂卫生标准 |
| GB 27954-2020 General Requirements for Disinfectant of Mucous Membrane 黏膜消毒剂通用要求 | GB26372-2020 Hygienic Requirements for Glutaraldehyde disinfectants 戊二醛消毒剂卫生标准 |
| GB26373-2020 Hygienic Requirements for alcohol disinfectants 乙醇消毒剂卫生标准 | |
| GB/T 27947-2020 Hygienic Requirements for Phenol Disinfectant 酚类消毒剂卫生要求 | |
| WS /T 646-2019 Hygienic requirement for sodium percarbonate disinfectant 过碳酸钠消毒剂卫生要求 | |
| WS /T 647-2019 Hygienic requirement for lysostaphin and lysozyme disinfectants 溶葡萄球菌酶和溶菌酶消毒剂卫生要求 | |
| GB/T 36758-2018 Hygienic requirements for disinfectants with chlorine 含氯消毒剂卫生要求 |
