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GB 27954-2011

GB 27954-2011_English: PDF (GB27954-2011)
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GB 27954-2011English319 Add to Cart Days<=3 General standard for disinfectant of mucous membrane GB 27954-2011 Obsolete GB 27954-2011
 

BASIC DATA
Standard ID GB 27954-2011 (GB27954-2011)
Description (Translated English) General standard for disinfectant of mucous membrane
Sector / Industry National Standard
Classification of Chinese Standard C59
Classification of International Standard 11.080
Word Count Estimation 8,881
Date of Issue 2011-12-30
Date of Implementation 2012-05-01
Quoted Standard Chinese Pharmacopoeia; disinfection technical specifications Ministry of Health; Hygienic Standard for Cosmetics Ministry of Health; disinfection product label instructions management practices Ministry of Health
Drafting Organization Jiangsu Province 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 mucous membrane disinfectant technical requirements, test methods, the use of methods, labels and instructions and precautions. This standard applies to medical institutions for treatment after mucosal disinfectant disinfectant. This standard does not apply to mucosal anti- antibacterial products and non -medical use of the mucosa disinfection disinfectant.

GB 27954-2011
General standard for disinfectant of mucous membrane
ICS 11.080
C59
National Standards of People's Republic of China
Mucous membrane disinfectants General requirements
Issued on. 2011-12-30
2012-05-01 implementation
People's Republic of China Ministry of Health
Standardization Administration of China released
Foreword
All the technical contents of this standard is mandatory.
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is proposed and administered by the People's Republic of China Ministry of Health.
This standard is mainly drafted by. Jiangsu Provincial Disease Prevention and Control Center, Chinese Center for Disease Control and Prevention, Shenzhen Disease Control and Prevention
center.
Participated in the drafting of this standard. Jiangsu love upon Health Products Co., Ltd., Shenzhen City Industrial Development Co., Andover.
The main drafters of this standard. Xu Yan, Sun Jun, Zhang stream wave, sink into the open, to talk about wisdom, Wu Gang, Chenyue Ying, Wu Xiaosong, pear Zhu Xi, Yi Rong, Wang Xiaolei,
Wang Ling.
Mucous membrane disinfectants General requirements
1 Scope
This standard specifies the technical requirements of the mucosa disinfectant, test methods, the use of methods, labels and instructions and precautions.
This standard applies to medical clinics and health institutions around the mucous membrane disinfectants for disinfection.
This standard does not apply to products and mucosal anti antibacterial mucosal non-medical use of disinfection disinfectant.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
People's Republic of China Pharmacopoeia
The Ministry of Health disinfection technical specifications
Hygienic Standard for Cosmetics Ministry of Health
Disinfection product label instructions management practices Ministry of Health
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Mucous membrane disinfection disinfectionofmucousmembrane
Killing or removal process oral, nasal, vaginal and external genital mucosal pathogens and meet disinfection requirements.
3.2
Mucous membrane disinfectants disinfectantformucousmembrane
For mucous membrane disinfection chemicals.
4. Technical Requirements
4.1 Requirements for raw materials
4.1.1 raw materials
It should follow the "People's Republic of China Pharmacopoeia", medical, food-grade or chemically pure quality requirements, may not use industrial grade.
4.1.2 Prohibited Substances
Various ingredients of prescription drugs such as antibiotics, antifungal drugs, hormones and other banned substances and health administration department under.
4.1.3 Water Production
It should follow the "People's Republic of China Pharmacopoeia" purified water requirements.
4.2 Quality requirements
4.2.1 sensory properties
Disinfectant evenly not hierarchical, no precipitation and suspended solids, no smell.
4.2.2 Physical indicators
4.2.2.1 disinfectant active ingredient content, pH, and other physical and chemical indicators in line with product quality standards. Expiration date ≥12 months.
4.2.2.2 active ingredients and active ingredient content of impurities ≤500mg/L, chlorhexidine gluconate, chlorhexidine acetate or limited application of povidone-iodine solution
L total amount of chlorhexidine in the total amount of active ingredient applied liquid ≤5000mg /, triclosan Disinfectant liquid active ingredient
≤3500mg/L, benzalkonium bromide or benzalkonium chloride disinfectants in the total amount of active ingredient applied liquid ≤2000mg/L. Lead <40mg/L, Hg <
1mg/L, arsenic <10mg/L.
4.2.3 kill microbiological indicators
Case by product specification use concentration to kill microorganisms indicators should comply with the requirements of Table 1.
Table 1 kill microbiological indicators
project
index
Action time
min
Killing