PDF Actual Sample: GB 27950-2011 (Release/modified date: 2020-04-25/2020-04-25. Wayne Zheng et al.)
| Standard ID | GB 27950-2011 (GB27950-2011) |
| Description (Translated English) | Hygienic requirements for hand antiseptic agents |
| Sector / Industry | National Standard |
| Classification of Chinese Standard | C59 |
| Classification of International Standard | 11.080 |
| Word Count Estimation | 7,734 |
| Date of Issue | 2011-12-30 |
| Date of Implementation | 2012-05-01 |
| Quoted Standard | GB 15982; Chinese Pharmacopoeia 2005; disinfection technical specifications Ministry of Health; Hygienic Standard for Cosmetics Ministry of Health; disinfection product label instructions management practices Ministry of Health |
| Drafting Organization | Hunan Provincial Center for Disease Control |
| Administrative Organization | Ministry of Health |
| Regulation (derived from) | Announcement of Newly Approved National Standards No. 23 of 2011 |
| Proposing organization | People's Republic of China Ministry of Health |
| Issuing agency(ies) | Ministry of Health of People's Republic of China; Standardization Administration of China |
| Summary | This Chinese standard specifies the technical requirements of hand sanitizer, test methods, the use of methods, label instructions and precautions. This standard applies to iodine, alcohols, guanidine, quaternary ammonium salts, phenols as raw materials, water or ethanol as a solvent to prepare for hand disinfection disinfectant. This standard does not apply for skin disinfection disinfectant. |
ENGLISH: GB 27950-2011 (Translated) GB 27950-2011
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 59
Hygienic requirements for hand antiseptic agents
手消毒剂卫生要求
ISSUED ON: DECEMBER 30, 2011
IMPLEMENTED ON: MAY 01, 2012
Issued by: Ministry of Health of the People's Republic of China;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Technical requirements ... 5
5 Inspection methods ... 6
6 Use methods ... 7
7 Labels and user manual ... 8
8 Precautions ... 8
Hygienic requirements for hand antiseptic agents
1 Scope
This Standard specifies technical requirements, inspection methods, use
methods, label manual and precautions for hand antiseptic agents.
This Standard is applicable to antiseptic agents that take iodine, alcohols,
guanidine, quaternary ammonium salts, phenols as raw materials, and water or
ethanol as a solvent for hand antisepsis.
This Standard is not applicable to antiseptic agents for skin disinfection.
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 15982, Hygienic standard for disinfection in hospitals
Pharmacopoeia of the People's Republic of China (2005)
Disinfection Technical Specifications -- Ministry of Health
Cosmetic Hygienic Specifications -- Ministry of Health
Specification for Management of Label Instructions for Disinfection Products
-- Ministry of Health
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 hand antisepsis
The process of killing or removing pathogenic microorganisms in the hand and
meeting disinfection requirements. It can be divided into hygienic hand
antisepsis and surgical hand antisepsis.
3.2 hand antiseptic agent
5.2 Physical-chemical indicators
5.2.1 pH measurement
Measure according to the relevant methods in Disinfection Technical
Specifications.
5.2.2 Active ingredient content
Measure according to the relevant methods in Disinfection Technical
Specifications and national standards.
5.2.3 Stability test
Measure according to the relevant methods in Disinfection Technical
Specifications.
5.2.4 Determination of lead, mercury and arsenic limits
Measure according to the relevant methods in Cosmetic Hygiene Regulations.
5.3 Killing microorganism test
Measure according to the relevant methods in Disinfection Technical
Specifications.
5.4 Toxicological safety test
Measure according to the relevant methods in Disinfection Technical
Specifications.
6 Use methods
6.1 Hygienic hand antisepsis
Take the right amount of hand antiseptic agent on the palm. Rub hands together
to evenly coat each part. Act 1.0min.
6.2 Surgical hand antisepsis
After washing hands surgically, apply an appropriate amount of hand antiseptic
agent and apply it evenly to the skin of the hands, forearms and 1/3 of the skin
under the upper arm. Act 3min~5min.
......
(Release/modified date: 2020-04-25 / 2020-04-25. Wayne Zheng et al.)