GB27951-2021

General requirements for skin disinfectant

皮肤消毒剂通用要求

GB 27951-2021 は現行の中国強制国家規格です：General requirements for skin disinfectant。業界：食品。テーマ：製品安全。施行日：2022年11月1日。

適用可否は製品範囲、認証ルート、所管当局の通知、移行規定によって異なります。コンプライアンス判断に使う前に、翻訳をご依頼いただくか公式情報源をご確認ください。

コンプライアンス概要

この概要は現在英語のみで提供しています。

適用範囲

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.

技術要求

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.

試験方法

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.

よくある質問

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.

適用のヒント

種別: 衛生
CCS: C50
ICS: 11.080
所管部門: National Disease Control and Prevention Administration
技術委員会: National Disease Control and Prevention Administration