GB27954-2020
General requirements for disinfectant of mucous membrane
黏膜消毒剂通用要求
GB 27954-2020 is a current mandatory Chinese national standard for General requirements for disinfectant of mucous membrane. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Nov 1, 2020.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
This standard specifies the requirements for mucous membrane disinfectants used in medical and healthcare institutions. It is mandatory for all manufacturers producing disinfectants intended for mucosal application, such as those for oral, vaginal, and external genitalia disinfection. It does not apply to disinfectants used for general skin or environmental surfaces.
Technical requirements
The standard outlines comprehensive technical requirements covering raw materials, physicochemical properties, and safety. For raw materials, it mandates that active ingredients like iodine-based, guanidine-based, and quaternary ammonium compounds must comply with their respective referenced standards. It strictly prohibits the use of prescription drugs, antibiotics, and hormones. Regarding physicochemical and microbial efficacy, the standard requires that products maintain an effective concentration, stability, and pH value with a shelf life of over 12 months. Disinfectants must demonstrate specific log reduction values against targeted microorganisms including Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans under both suspension and carrier test methods. Safety requirements dictate that products must be practically non-toxic or low in acute oral toxicity, non-mutagenic, and exhibit no to mild irritation for eye and vaginal mucosa. Additionally, the standard sets strict limits on heavy metals (lead, mercury, arsenic) and requires the final product to be sterile with stringent limits on microbial contamination during use.
Testing methods
Testing methods involve determining the active ingredient content, stability, and pH value according to the Disfection Technical Specification (2002 Edition). Heavy metal limits (lead, mercury, arsenic) are tested per the Safety and Technical Standards for Cosmetics (2015 Edition). Microbial efficacy and safety tests are also conducted following the Disinfection Technical Specification, while microbial contamination tests follow the methods specified in GB 27951.
FAQs
What products are regulated under GB 27954-2020?
GB 27954-2020 regulates mucous membrane disinfectants used in medical and healthcare institutions, including those based on iodine, chlorhexidine, and quaternary ammonium compounds for oral, vaginal, and external genitalia disinfection.
Are there any updates from the previous version of GB 27954?
Yes, compared to GB 27954-2011, the 2020 version adds normative references, microbial contamination indicators, and carrier method microbial kill tests. It also removes the sub-acute oral toxicity test and merges labeling and precautions into a single identification chapter.
What are the key safety requirements for mucosal disinfectants under this standard?
The standard requires that mucosal disinfectants be practically non-toxic or low in acute oral toxicity, non-mutagenic, and cause no or only mild/very mild irritation to the eyes and vaginal mucosa. They must also be sterile and free from prohibited substances like antibiotics and hormones.
The summary above provides a high-level overview of GB 27954-2020. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 27954-2020 today to access all detailed parameters, tables, and testing procedures.
Applicability hints
- Type
- Product
- CCS
- C50
- ICS
- 11.080
- Competent department
- National Disease Control and Prevention Administration
- Technical committee
- National Disease Control and Prevention Administration
Relationships
Replaces:GB 27954-2011