GB27950-2020

General requirements for hand disinfectant

手消毒剂通用要求

GB 27950-2020 es una norma nacional china obligatoria vigente: General requirements for hand disinfectant. Sector: Alimentos. Enfoque: Seguridad de productos. Entrada en vigor: 1 nov 2020.

La aplicabilidad depende del alcance del producto, la vía de certificación, los avisos de la autoridad competente y las reglas de transición. Solicite una traducción o verifique la fuente antes de usar esta ficha en una decisión de cumplimiento.

Resumen de cumplimiento

Este resumen está disponible por ahora solo en inglés.

Alcance y aplicabilidad

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.

Requisitos técnicos

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.

Métodos de ensayo

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.

Preguntas frecuentes

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.

Indicaciones de aplicabilidad

Tipo: Producto
CCS: C50
ICS: 11.080
Organismo competente: National Disease Control and Prevention Administration
Comité técnico: National Disease Control and Prevention Administration

Relaciones

Sustituye a:GB 27950-2011