手消毒剂卫生要求

National Standard of People’s Republic of China GB 27950-2011 Hygienic requirements for hand disinfectants

1.General

This standard stipulates technological requirements, testing methods,

instructions, applications, labels and cautions for hand disinfectants.

This standard applies to hand disinfectants that are made of iodine, alcohol, guanidines, quaternary ammonium salt, phenols or use water or alcohol as

solvents.

This standard is not applicable to the skin disinfectants.

2.Normative cited documents

The following documents are indispensable to the application of this document.

For cited documents with dates on it, only the dated version apply to this

document. For the cited documents without dates on it, only the latest version apply to this document.

GB 15982 Hospital disinfection hygiene standards

Pharmacopoeia of People's Republic of China (2005)

Technical Standards for Disinfection Health Ministry

Cosmetics hygiene standards Health Ministry

Label and Instruction Manual Regulation Specification of Disinfection Products Health Ministry

3.Terminology and Definitions

The following terminology and definitions are applicable to this documents.

3.1Hand disinfection

The process of killing or eliminating pathogenic microorganism and

reaching the disinfection requirements. It can be classified into hygiene

hands disinfection and surgical hands disinfection.

3.2hand disinfectants

chemical agents that can apply to hand disinfection

3.3Hygiene hands disinfection

The process of preventive hands disinfection

3.4Surgical hands disinfection

The process of disinfection for medical staff’s hands and forearms before

operations.

4.Technological requirements

4.1raw material requirements

4.1.1Raw materials should conform with Pharmacopoeia of People's

Republic of China and the quality requirements for pharmaceutical

grade and food grade or chemically pure. The industrial grade is

forbidden.

4.1.2The formulations should not contain ingredients of ethical drugs like

hormone, antibiotics and antifungal drug and materials banned by

Health Ministry.

4.1.3The water for manufacturing is deionized water or distilled water.

4.2quality requirements

4.2.1appearance

The disinfectants should be even without separate layers , sediments,

suspended substance and strange smell.

4.2.2physicochemical indexes

4.2.2.1quality standards

The physicochemical indexes like the disinfectants’ active

ingredients percentage and PH value should conform with

quality standard. Shelf life ≥12 months

4.2.2.2quantity limits for active ingredients

The active ingredients of guanidine disinfectants ≤4.5%,

benzalkonium bromide or Benzalkonium Chloride ≤0.5%，

HD-244≤2.0%.

4.2.2.3limits for impurity

lead＜40mg/L, mercury＜1mg/L, arsenic＜10mg/L

4.2.3indexes for killing microbes

the indexes for killing microbes should conform with the requirements

of the table below