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GB 27954-2011

Chinese Standard: 'GB 27954-2011'
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GB 27954-2011English159 Add to Cart Days<=3 General standard for disinfectant of mucous membrane Valid GB 27954-2011
GB 27954-2011Chinese14 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

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 logarithm value
Staphylococcus aureus
ATCC6538
≤5.0 ≥5.00
Pseudomonas aeruginosa
ATCC15442
≤5.0 ≥5.00
Candida albicans
ATCC10231
≤5.0 ≥4.00
Natural bacteria (Field Test) ≤5.0 ≥1.0
Note. The field test field test for the mucosa (skin substitute is available).
4.2.4 toxicological safety indicators
Toxicology test results should meet the requirements of Table 2.
Table 2 toxicological safety indicators
Project decision index
Acute oral toxicity test actual non-toxic or low toxicity
A mutagenicity test without mutagenicity
Primary eye irritation test (occasionally) no stimulation or mild irritation
Many eye irritation test (repeated use) No light stimulation or irritation
A vaginal mucous membrane irritation test (occasionally) very light or no stimulation irritating
Repeated vaginal mucous membrane irritation test (repeated use) no stimulation or very light irritation
Subacute oral toxicity test (repeated use) was not observed toxicity
NOTE. occasionally. that occasional use or use interval days, repeated use. daily use or use for several days.
5 test methods
5.1 Appearance
Visual inspection.
5.2 Physical indicators
5.2.1 Stability
According to relevant regulations, "disinfection technical specifications" were determined.
5.2.2 The active ingredient content is detected
Press the "disinfection technical specifications", determined by the method specified in Appendix A.
5.2.3 lead, mercury, arsenic limit determination
Press the "Hygienic Standard for Cosmetics," about the method were determined.
5.3 kill microbial test
According to relevant regulations, "disinfection technical specifications" were determined.
5.4 Toxicological Safety Test
According to relevant regulations, "disinfection technical specifications" were determined.
6 Use
6.1 disinfection oral mucosa. a cotton swab to clean, rinse.
6.2 vaginal mucosa disinfection. cotton swab wipe lavage.
6.3 nasal disinfection. wipe a cotton swab.
6.4 genitalia disinfection. cotton swab to clean, wash.
7 labels and instructions
According to the relevant provisions of "sterile product label instructions management practices."
8 Precautions
8.1 mucosa disinfectant poured from the original packaging should be disposable.
8.2 topical disinfectant, not oral, placed in the reach of children.
8.3 avoid antagonizing drugs with the use.
8.4 allergy caution.
8.5 dark, sealed, moisture, cool, dry place.
8.6 expiration date.
8.7 may not be as mucosal therapeutic drug use, only clinics with medical and health institutions.
8.8 vaginal mucous membrane disinfectant "shall not be used for prevention of sexually transmitted diseases, sexual life."
Appendix A
(Normative)
Determination polyhexamethylene biguanide content (Colorimetric)
A.1 Principle
Detection principle is the color reaction between poly biguanide (PHMB) and eosin (Eosin dye), color change can be achieved by wave
Long 545nm measured absorbance values.
A.2 Instruments
A.2.1 visible spectrophotometer.
A.2.2 1cm cuvette.
A.2.3 glassware.
8 25mL volumetric flask;
A 100mL volumetric flask;
A 250mL volumetric flask;
A 500mL volumetric flask;
1.0mL, 2.0mL, 2.5mL, 4.0mL, 6.0mL, 8.0mL 10.0mL and pipette.
A.3 reactants required
A.3.1 EosinY (aqueous Eosin Y).
A.3.2 PHMB standards.
A.3.3 sodium acetate trihydrate.
A.4 procedural steps
A.4.1 instructions to prepare a solution
0.6g said water-soluble eosin Y, into the 250mL beaker, approximately 50mL of warm distilled water and cooled. Transferred to
100mL standard volumetric flask with distilled water volume to 100mL. Mix well to obtain a solution A.
10mLA with pipette solution, distilled water volume to 250mL, was instructed liquid.
Prepare A.4.2 acetate solution
10g of sodium acetate were dissolved in 100mL of distilled water.
A.4.3 Prepare standard curve
Standards were prepared with a concentration of 0.8mg/L, 1.6mg/L, 3.2mg/L, 4.8mg/L, 6.4mg/L of standard PHMB
Quasi-liquid.
The adjusted wavelength 545nm, measurement of the absorbance values of standard solutions of different concentrations, and the standard curve.
Calculation A.4.4 unknown solutions
Pipette 10mL with unknown concentration PHMB solution to a 25mL volumetric flask, add 1mL acetic acid solution and 2.5mL instructions
Liquid, distilled water volume to 25mL, shake vigorously, and mix well.
Spectrophotometer with absorbance values of unknown concentration PHMB solution.
A.4.5 Results/Calculation
According to the standard curve, calculating the unknown PHMB content of the solution.
Related standard:   GB 27954-2020  GB 27948-2020
Related PDF sample:   GB 27954-2020  GB 27948-2020
   
 
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