GB27951-2021

General requirements for skin disinfectant

皮肤消毒剂通用要求

GB 27951-2021 es una norma nacional china obligatoria vigente: General requirements for skin disinfectant. Sector: Alimentos. Enfoque: Seguridad de productos. Entrada en vigor: 1 nov 2022.

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

This standard specifies the general requirements for skin disinfectants used on both intact skin and damaged skin. It applies to manufacturers and distributors of chemical disinfectants intended for human skin application in the Chinese market. It is mandatory for all skin disinfectant products entering China. The standard does not apply to general sanitizers or hand rubs unless explicitly marketed for skin disinfection.

Requisitos técnicos

The standard outlines comprehensive technical requirements categorized into raw materials, physicochemical properties, microbial limits, and safety. For raw materials, active ingredients like guanidine and iodine-based compounds must comply with their respective specific national standards, while excipients and production water must meet Pharmacopoeia requirements. Regarding physicochemical and microbial indicators, the standard mandates that products maintain an effective shelf life of over 12 months. It sets strict limits on microbial contamination, requiring products for damaged skin to be completely sterile. Manufacturers must ensure no pathogenic bacteria such as Staphylococcus aureus or Pseudomonas aeruginosa are detectable. In terms of safety, the standard enforces strict toxicological limits, requiring tests for acute oral toxicity and skin irritation. It also sets maximum concentration limits for heavy metals, specifically lead, mercury, and arsenic. Prescription components like antibiotics and hormones are strictly prohibited as active ingredients.

Métodos de ensayo

Testing procedures include physicochemical analysis for active ingredient content and pH value, typically conducted according to the Technical Standard for Disinfection (2002 edition). Microbial efficacy is evaluated through quantitative suspension and carrier tests against specific strains like Staphylococcus aureus and Candida albicans. Safety assessments involve toxicological testing and heavy metal detection, while prohibited substances are screened using methods specified in WS/T 684, WS/T 685, and WS/T 686.

Preguntas frecuentes

What products are regulated under GB 27951-2021?

GB 27951-2021 regulates skin disinfectants intended for use on human skin, covering both intact skin and damaged skin. It applies to various chemical formulations including alcohol-based, iodine-based, and quaternary ammonium compound disinfectants.

Are there any updates from the previous version of GB 27951-2021?

Yes, compared to GB 27951-2011, the 2021 version adds requirements for raw materials, updates the definition of intact skin, and revises toxicological indicators by adding a multiple skin irritation test. It also introduces testing requirements for prohibited substances like antibiotics and antifungal drugs.

How does GB 27951-2021 differ from ISO standards?

While ISO standards provide general guidelines for disinfectants, GB 27951-2021 is a mandatory Chinese national standard tailored specifically for the domestic market. It includes specific limits on heavy metals like lead and mercury, and explicitly prohibits the use of prescription drug components, which may not be as strictly regulated in international standards.

The summary above provides a high-level overview of GB 27951-2021. 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 27951-2021 today to access all detailed parameters, tables, and testing procedures.

Indicaciones de aplicabilidad

Tipo: Salud e higiene
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 27951-2011