GB27950-2020
General requirements for hand disinfectant
手消毒剂通用要求
GB 27950-2020 is a current mandatory Chinese national standard for General requirements for hand disinfectant. 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
GB 27950-2020 applies to chemical disinfectants intended for hygienic hand antisepsis and surgical hand antisepsis. It covers various formulations including alcohol-based hand rubs and waterless antiseptic agents used in medical and healthcare settings. This standard is mandatory for all manufacturers producing hand disinfectants for the Chinese market.
Technical requirements
This standard specifies the mandatory technical requirements for hand disinfectants, covering raw materials, physicochemical properties, and microbiological efficacy. Raw materials must comply with the Pharmacopoeia of the People's Republic of China (2015 Edition) or meet medical/food-grade standards. The standard sets limits for effective ingredient content and requires the pH value to be within ±1 of the labeled value. Manufacturers must ensure the product shelf life is no less than 12 months and validate the post-opening usage validity. Furthermore, the formulation must strictly exclude prohibited substances such as hormones, antibiotics, and antifungal drugs, while heavy metal limits for lead, arsenic, and mercury are strictly defined.
Testing methods
Testing protocols are primarily based on the Technical Specification for Disinfection (2002 Edition). Key evaluations include tests for microbial kill efficacy (e.g., E. coli, S. aureus, Candida albicans, and Poliovirus) using suspension and carrier methods. Toxicological safety assessments cover acute oral toxicity, skin irritation, and mutagenicity. Additionally, heavy metal content is tested according to the Safety and Technical Standards for Cosmetics (2015 Edition). A normative appendix provides a specific testing method to determine the post-opening usage validity by simulating real-world hospital usage conditions.
FAQs
What products are regulated under GB 27950-2020?
GB 27950-2020 applies to chemical disinfectants used for hygienic hand antisepsis and surgical hand antisepsis, including alcohol-based hand rubs and waterless antiseptic agents.
Are there any updates from the previous version of GB 27950-2020?
Yes, compared to GB 27950-2011, the 2020 version introduces new terms like "alcohol-based hand rub" and "waterless antiseptic agent", updates raw material and technical requirements, and adds a normative appendix for testing the post-opening usage validity.
Is GB 27950-2020 a mandatory standard?
Yes, all technical contents within GB 27950-2020 are mandatory for manufacturers producing and selling hand disinfectants in the Chinese market.
The summary above provides a high-level overview of GB 27950-2020. 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 27950-2020 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 27950-2011