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All the technical contents of this standard are mandatory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB 27950-2011 Hygienic requirements for hand antiseptic agents. The following main technical changes have been made with respect to GB 27950-2011:
——some normative references are added;
——in the clause of "Terms and definitions", "alcohol-based hand rub" and "waterless antiseptic agent" are added;
——the requirements are modified for the raw materials;
——the technical requirements are modified;
——the inspection methods are modified.
——the surgical hand antisepsis is modified to be conducted according to WS/T 313;
——the Normative Annex A "Inspection methods for useful life after products are used" is added.
This standard was proposed by and is under the jurisdiction of the National Health Commission of the People's Republic of China.
The previous edition of this standard is as follows:
——GB 27950-2011.
General requirements for hand disinfectant
1 Scope
This standard specifies the requirements for raw materials, technical requirements, inspection methods, application methods and marking of hand disinfectant.
This standard is applicable to disinfectants for hygienic hand antisepsis and surgical hand antisepsis.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 15982 Hygienic standard for disinfection in hospitals
WS/T 313 Specification of hand hygiene for healthcare workers
Pharmacopoeia of the People's Republic of China (Edition 2015)
Safety and technical standards for cosmetics (Edition 2015)
Technical standard for disinfection (Edition 2002) [issued by the Ministry of Health of the People's Republic of China (WEIFAJIANFA [2002] No.282)]
Management standard for labels and instructions of disinfectant products (Edition 2009) [issued by the Ministry of Health of the People's Republic of China (WEIJIANDUFA [2009] No.53)]
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
hand antisepsis
the treatment process of killing or eliminating microorganisms on hands and achieving harmlessness
Note: It may be divided into hygienic hand antisepsis and surgical hand antisepsis.
3.2
hand disinfectant
chemical preparations used for hand antisepsis
3.3
alcohol-based hand rub
hand disinfectant containing alcohol and skin care ingredients
Note: Dosage forms include aqua, gel and foam.
3.4
waterless antiseptic agent
hand disinfectant mainly used for surgical hand antisepsis that does not need to be washed with water after use
Note: Dosage forms include aqua, gel and foam.
3.5
hygienic hand antisepsis
process of rubbing hands with hand disinfectant to reduce the transient flora on hands
3.6
surgical hand antisepsis
process that medical staffs rub and rinse their hands with flowing water and hand sanitizer, and then use hand disinfectant to eliminate or kill transient flora and reduce resident flora on their hands before surgery
4 Requirements for raw materials
4.1 The raw materials shall meet the quality requirements of the Pharmacopoeia of the People’s Republic of China (Edition 2015) or medical or food grade or other corresponding standards.
4.2 Production water shall meet the requirements of Hygienic code for disinfectant product manufacturer (Edition 2009).
5 Technical requirements
5.1 Content of active ingredients
The content of active ingredients shall meet the requirements of national standards or quality standards of corresponding products.
5.2 pH value
The pH value of hand disinfectant shall be within the range of the marked value ± 1.
5.3 Shelf life
5.3.1 The shelf life of products shall not be less than 12 months.
5.3.2 The useful life after the product is used shall meet the requirements of the instruction manual.
5.4 Microorganism killing index
According to the characteristics of hand disinfectant products, the effect of microorganism killing index shall meet the requirements of Table 1.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for raw materials
5 Technical requirements
6 Inspection methods
7 Application methods
8 Marking
Annex A (Normative) Inspection methods for useful life after products are used
