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GB 27947-2011

Chinese Standard: 'GB 27947-2011'
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GB 27947-2011English279 Add to Cart Days<=3 [GB/T 27947-2011] Hygienic requirements for phenol disinfectant Valid GB 27947-2011
GB 27947-2011Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID GB 27947-2011 (GB27947-2011)
Description (Translated English) [GB/T 27947-2011] Hygienic requirements for phenol disinfectant
Sector / Industry National Standard
Classification of Chinese Standard C59
Classification of International Standard 11.080
Word Count Estimation 14,192
Date of Issue 2011-12-30
Date of Implementation 2012-05-01
Quoted Standard GB/T 191; GB/T 2600; Chinese Pharmacopoeia; disinfection technical specifications Ministry of Health; disinfection products production enterprises standardize the Ministry of Health; disinfection product label instructions management practices Ministry of Health
Drafting Organization Zhejiang 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 phenolic disinfectant raw materials, product quality, range of applications, the use of methods, test methods, marking and packaging, transport and storage, labeling and instructions and precautions required. This standard applies to phenol, cresol, xylenol chloride, triclosan and other phenolic compounds as the main raw material, the use of appropriate surfactants, ethanol or isopropanol as solubilizers, ethanol or iso- propanol (or) water as a solvent, do not add other ingredients with a germicidal disinfectant. This standard does not apply to other unilateral or compound phenolic disinfectant.

GB 27947-2011
Hygienic requirements for phenol disinfectant
ICS 11.080
C59
National Standards of People's Republic of China
Phenolic disinfectants hygiene 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 was drafted. Disease Prevention and Control Center of Zhejiang Province, Zhejiang Province Health Authority, Hangzhou Center for Disease Control and Prevention, Ciba
Chemicals (China) Co., Ltd., Lee Benckiser (China) Co., Laimanhesi Health Products (Guangzhou) Co., Ltd., Tianjin Braun disinfection
Agent limited liability company.
The main drafters of this standard. Wei Lanfen, Lu Longxi, Xu Hao row, Sun Jianrong, Ma Mingjie, Wang Yurong, Huang Shaofeng, Liu Xianzhong.
Phenolic disinfectants hygiene requirements
1 Scope
This standard specifies the raw materials, product quality, range of applications, use, testing methods phenolic disinfectant, logo and packaging, transportation and storage
Deposit, labels and instructions and precautions requirements.
This standard applies to phenol, cresol, m-chloroperbenzoic xylenol, triclosan and other phenolic compounds as the main raw material, the use of appropriate
A surfactant, ethanol or isopropanol as solubilizers, ethanol or isopropanol (or) water as a solvent, without adding another message having a bactericidal component
Agents.
This standard does not apply to other unilateral or compound phenolic 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.
GB/T 191 Packaging - Pictorial signs
GB/T 2600 coking xylenol
People's Republic of China Pharmacopoeia
The Ministry of Health disinfection technical specifications
Disinfection products manufacturing enterprises health norms 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
Phenolic compounds phenoliccompounds
Aromatic hydrogen atoms in the benzene ring is substituted with hydroxy compounds generated, especially in this standard phenol, cresol, xylenol inter chlorine,
Triclosan.
3.2
Phenolic disinfectants phenoldisinfectant
Phenolic compounds in the main raw material, addition of a surfactant, solubilizer ethanol or isopropanol, ethanol or isopropanol, or water as a
Solvents, disinfectants add other sterilization components.
4 raw material requirements
4.1 General
Raw materials shall comply with relevant hygiene standards, norms and relevant regulations, and a corresponding quality inspection evidence. Those who are included in the "danger
Dangerous chemicals directory "disinfectant raw materials, should follow the" Regulations People's Republic of China Production Safety Law, "" dangerous chemical safety regulations ", etc.
Given the corresponding requirements.
4.2 Phenol (C6H6O)
Should follow the "People's Republic of China Pharmacopoeia" requirements, content ≥99.0%.
4.3 cresol (C7H8O)
It should follow the "People's Republic of China Pharmacopoeia" requirement, the distillation capacity of 190 ℃ ~ 205 ℃ of ≥85%.
4.4 xylenol (C8H10O)
Shall comply with GB/T 2600 requirements, the purity of ≥95%.
4.5 pairs between chloroxylenol (C8H9OCl)
Purity ≥98%, vulcanized ash ≤1%.
4.6 Triclosan (C12H2Cl3O2)
Purity of raw materials should be between (containing no crystal water gauge) from 97% to 103% 2,4-DCP content should ≤10mg/kg, 3- and 4-chloro-chlorophenol
Phenol content should ≤10mg/kg, 2,3,7,8 four chlorinated benzene -p- two and two  English <1.0ng/kg, 2,3,7,8 tetrachlorodibenzo furan <1.0ng/kg,
2,8-dichloro benzene -p- two and two  English ≤0.5mg/kg, 1,3,7-trichlorobenzene and benzene -p- two  two British ≤0.25mg/kg, 2,8-dichloro-furan
≤0.25mg/kg, 2,4,8-trichloro-furan ≤0.5mg/kg.
4.7 ethanol, isopropanol
Comply with the relevant provisions of "People's Republic of China Pharmacopoeia."
4.8 production quality requirements
Should follow the "disinfection products manufacturing enterprises health standards" requirements process water.
5 Phenolic Disinfectant product quality requirements
5.1 Sensory
Shall comply with phenolic disinfectant unique olfactory characteristics, and in accordance with the provisions of the product color, no impurities.
5.2 Physical indicators
Product physical and chemical indicators should meet the requirements of Table 1.
Table 1 Physical and Chemical Indicators
Item Index
A content of active ingredients
(Mass fraction)
Phenol, the application was a ≤5.0
Cresol, the application was a ≤5.0
Inter chloroxylenol
Skin disinfection, application of liquid ≤2.0
Surface disinfection, application of liquid ≤2.0
Wash hands with health, application of liquid ≤1.0
Mucosa disinfection, application of liquid ≤1.0
Table 1 (continued)
Item Index
A content of active ingredients
(Mass fraction)
Triclosan
Skin disinfection, application of liquid ≤2.0
Mucosa disinfection, application solution ≤0.35
pH
Phenol, cresol 6.0 to 10.0
Chloro-xylenol between 7.5 and 10.5
Triclosan 5.5 to 8.5.
Each application of a solution containing an active ingredient of a limited, without making the classifier, the active ingredient in the solution for all applications should not exceed the limit.
5.3 Stability
Products stored at room temperature, protected from light, shall be valid for not less than one year, the active ingredient during storage rate should be decreased ≤10%, and the yield
Appearance does not change significantly.
5.4 kill microbiological indicators
Germicidal efficacy shall comply with the requirements in Table 2.
Table 2 germicidal efficacy
Test
microorganism
Action time
min
Killing logarithm value
surgical
Wash your hands with
health
Wash your hands with
Surface
Wipe with
Soak items
Disinfection
The suspension of a carrier method b
E. ≤5 ≤1 ≤15 ≤30 ≥5.00 ≥3.00
Golden
Staphylococcus ≤5 ≤1 ≤15 ≤30 ≥5.00 ≥3.00
Pseudomonas
Pseudomonas ≤5 ≤1 ≤15 ≤30 ≥5.00 ≥3.00
Candida albicans ≤5 ≤1 ≤15 ≤30 ≥4.00 ≥3.00
Natural bacteria c
(Spot disinfection test) ≤5 ≤1 ≤15 ≤30 ≥1.00 ≥1.00
Artificial contamination c
(Simulated field disinfection test) ≤5 ≤1 ≤15 ≤30 ≥3.00 ≥3.00
After a thin shape or diluted sample for laboratory users should use suspension quantitative germicidal test quantitative method.
b specimen viscous liquid or user should be using a carrier quantitative germicidal test laboratory quantitative method.
c Select the appropriate disinfection and detection methods according to the product manual.
5.5 safety index
Liquid products or the highest concentration should belong to five times the amount of actual non-toxic, skin, eye mucosa, vaginal mucosa and other non-irritating to the skin weak
Allergenic, non-mutagenic, causing distortion effect, no in vivo genotoxicity.
6 Applications
6.1 phenol, cresol as main bactericidal disinfectant composition suitable for disinfecting surfaces and fabrics.
6.2 pairs between chlorine as a disinfectant xylenol main bactericidal component for hygienic hand washing, skin, mucous membranes, surface and fabric disinfection,
Which is limited to the mucosa disinfection before and after treatment using medical clinics.
6.3 Triclosan is the main bactericidal disinfectant components for hygienic hand washing, skin, mucous membranes, and the fabric article surface disinfection,
Which is limited to the mucosa disinfection before and after treatment using medical clinics.
7 Use
7.1 phenol, cresol as a main component of bactericidal disinfectant
Application of liquid active ingredient content ≤5.0%, on the surface, after disinfection fabric wiping action time ≤15min, soaking disinfection
No more than 30min.
7.2 pairs between chlorine as a disinfectant xylenol main bactericidal component
7.2.1 Health hand disinfection. the application of the active ingredient content was ≤1.0%, rival wipe or immersion disinfection action time ≤1min.
7.2.2 skin disinfection. the application of the active ingredient content was ≤2.0% wipe disinfection action time ≤5min.
7.2.3 surface disinfection. the application of the active ingredient content was ≤2.0%, after wiping action time ≤15min, disinfection soaking time
≤30min.
7.2.4 mucous membrane disinfection. the application of the active ingredient content was ≤1.0%, wipe or rinse disinfection time ≤5min.
7.3 Triclosan is the main component of bactericidal disinfectant
7.3.1 Health hand disinfection. Apply liquid active ingredient content ≤2.0%, wiping or immersion disinfection opponents, time was ≤1min.
7.3.2 skin disinfection. the application of the active ingredient content was ≤2.0%, wiping disinfection, the role of time ≤5min.
7.3.3 surface disinfection. the application of the active ingredient content was ≤2.0%, after wiping action time ≤15min, disinfection soaking time
≤30min.
7.3.4 mucous membrane disinfection. the application of the active ingredient content was ≤0.35%, wipe or rinse disinfection time ≤5min.
8 test methods
8.1 Appearance
The sample is placed within a colorless transparent glass bottle or glass, light visual inspection, sniffing.
8.2 Physical indicators
Test methods in Appendix A, Appendix B, Appendix C, Appendix D or press the "Disinfection technical specifications", "People's Republic of China Pharmacopoeia" to
Requirements, other suitable liquid chromatography method to test the product or active ingredient content.
8.3 germicidal efficacy
In accordance with the test method "disinfection technical specifications" set forth in the measurement.
8.4 toxicological safety
In accordance with the test method "disinfection technical specifications" set forth in the measurement.
9 logo and packaging
In line with GB/T 191 requirements.
10 transport and storage
10.1 Transportation
Transportation under sealed shipping containers require preservation, working with light-light, non-throwing. Transport should be sun, rain and moisture.
10.2 Storage
Cool and dry place, packaging should be tight to prevent moisture, stacking pads to more than 10cm from the ground, stack height not exceeding 12 boxes, and wall
Holding more than 20cm from the surface.
11 labels and instructions
Performed in "sterile product label instructions management practices" requirement.
12 Notes
12.1 topical disinfectant, not oral, mucosal disinfection treatment process is limited to the medical and health institutions.
12.2 phenol, cresol toxic to humans, the environment and surface disinfection, should be good personal protection, if high concentrations
Solution come into contact with the skin, can wipe ethanol or flush with water.
Skin disinfection prior to 12.3, you must first clean the skin. Surface with dirt before disinfection should also do the clean decontamination work.
12.4 After disinfection, the treated surface response, fabrics and other objects with water to wipe or wash to remove residual disinfectant.
12.5 product can not be used to sterilize bacterial spores contaminated items; medical devices can not be used for high and intermediate level disinfection; phenol, cresol as the main
Disinfectant ingredient does not apply to the skin, mucous membrane disinfection.
Appendix A
(Informative)
Determination of phenol content in disinfectant
A.1 Principle
Using volumetric analysis. Sample phenol under acidic conditions after reaction with excess bromine full role, the excess bromine and potassium iodide yield
Health and iodine, sodium thiosulfate standard solution titration, based on the amount of bromine consumed by the sample to calculate the content of phenol in disinfectants.
A.2 Methods
A.2.1 sodium thiosulfate (0.1mol/L) Preparation and Calibration
A.2.1.1 preparation
Weigh Na2S2O3 · 5H2O26g, anhydrous sodium carbonate 0.20g, dissolved in distilled water into 1000mL, shake. Packed in brown glass
Glass bottle, set in the dark by filtration and concentration 30d after calibration.
A.2.1.2 Calibration
He said learn 120 ℃ drying to constant weight, baseline potassium dichromate 0.15g (accurate to 0.0001g), placed in 250mL iodometric flask, add
Distilled water 50mL dissolved. Plus 2mol/L sulfuric acid 15mL and 200g/L potassium iodide solution 10mL, capped and mixed with distilled water several
Drops of iodine bottle edge, set in the dark after 10min plus distilled water 90mL. At room temperature 20 ℃ ~ 25 ℃, with installed in 50mL burette
Thiosulfate titration droplet given to the solution was light yellow, plus 5g/L 10 drops of starch solution (solution immediately turns blue) and continue titration to the solution of
Blue to bright green. Record total sodium thiosulfate solution milliliters, and titration with blank test correction. If there are blank test
Consumption of sodium thiosulfate, titrant milliliters of sodium thiosulphate titrated spent will be subtracted from the amount of blank test, thiosulfate was corrected
Milliliters of sodium titrant. Because 1mol/L sodium thiosulfate solution 1mL equivalent 0.04903g dichromate, therefore according to equation
(A.1) to calculate the concentration of sodium thiosulfate solution.
c (mol/L) = m0.04903 × V
(A.1)
Where.
C --- sodium thiosulfate solution concentration, in units of moles per liter (mol/L);
m --- iodine bottle of potassium dichromate mass in grams (g);
V --- sodium thiosulfate solution (minus blank) volume in milliliters (mL).
0.04903 --- 1.00mL dichromate and sodium thiosulfate standard solution [c (NaS2O3) = 1.000mg/L] equivalent in grams
Quality potassium.
A.2.2 bromine titration solution (0.05mol/L) Preparation and Calibration
A.2.2.1 preparation
Take 3.0g potassium bromate and potassium bromide 15g, add water to dissolve and dilute to 1000mL, and mix.
A.2.2.2 Calibration
The precision drawing solution 25mL set iodometric bottle, add water 100mL with potassium iodide 2.0g, shake to dissolve, add hydrochloric acid 5mL, immediately vibrator
Shake 30s, dark place 5min. In (0.1mol/L) titrated with sodium thiosulfate standard solution, to near the end, plus 0.5% starch indicator
Solution 2mL, continue titration to the disappearance of the blue. According to the consumption of sodium thiosulfate to calculate the concentration of the solution, that is, too. The solution should be every time before use
The nominal concentration.
A.2.3 Determination of phenol content in disinfectant
Take appropriate disinfectants (phenol-containing approximately 0.75g) into 500mL volumetric flask, add water to dissolve and dilute to volume, mix well
Uniform; precision drawing 25mL set iodometric bottle, precision bromine titration solution (0.05mol/L) 30mL, plus hydrochloric acid 5mL, immediately Mesa, shake
30min, 15min after standing, pay attention to slightly open the cork, plus potassium iodide test solution 6mL, immediately Mesa, after shaking well, add chloroform 1mL,
With standard sodium thiosulfate solution (0.1mol/L) titration to near the end, plus 0.5% starch indicator solution 1mL, continue titration until the blue Consumers
Loss, and titration with blank test correction. Each 1mL (0.05mol/L) is equivalent to 1.569mg of phenol (C6H6).
Appendix B
(Informative)
Test methods in disinfectant cresol isomer content
B.1 Principle
Using column separation, hydrogen flame ionization detector, based on retention time qualitative and quantitative peak height or peak area.
B.2 Chromatographic conditions and system suitability test reference
Adipic acid glycol polyester containing 2% phosphoric acid as the stationary phase, the coating concentration of 4% to 10% hydrogen flame detector, column temperature
145 ℃, injector and detector temperature was 200 ℃.
B.3 Determination of the correction factor
Precision water Yang aldehyde of about 1.3g, set 50mL volumetric flask, add ether to dissolve and dilute to the mark, shake, as the internal standard solution.
Another accurately weighed ortho-cresol reference about 0.65g, to 25mL volumetric flask, add ether to dissolve and dilute to the mark, shake, as
Reference solution. The precise amount of the reference solution and internal standard solution 5mL, set stoppered test tube, Mesa, shake. Take 1μL injection gas chromatography
Spectrometer, ortho-cresol calculated correction factor, then multiplied by 1.042, i.e. between, para-cresol correction factor.
B.4 sample determination
Precision to take this product 1.0g set separating funnel, concentrated hydrochloric acid 0.1mL, shake, add water, 3mL, shake, the precise addition of ether
20mL, shaking gently, standing layer, the aqueous layer was discarded, add water, 5mL, shaking gently, layered, discard the aqueous layer. The precise amount of ether extract
5mL and the internal standard solution 5mL, set stoppered test tube, shake, take 1μL injected into the gas chromatograph to measure.
B.5 formula
x =
(A1 × f1 A2 × f2) × m1
A × m × 100%
(B.1)
Where.
X --- cresol content,%;
A --- internal standard peak area;
A1 --- ortho-cresol peak area;
A2 --- Room, para-cresol peak area;
f1 --- ortho-cresol correction factor;
f2 --- Room, para-cresol correction factor;
m1 --- internal standard substance mass in grams (g);
m --- cresol sample mass, in grams (g).
Appendix C
(Informative)
Determination of disinfectants between chlorine content of xylenol
C.1 Principle
Inter chloroxylenol have UV absorption, the available phase high performance liquid chromatography (HPLC) separation of 220nm wavelength, and the retention
Time qualitative and quantitative peak area. This method is applicable to the determination of chlorine disinfectant between xylenol active ingredients right.
C.2 reagent preparation
Methanol (HPLC grade); inter chloroxylenol standard solution. Weigh inter chloroxylenol standard 0.1g, with a small amount of methanol was dissolved and
Constant volume to 100mL, 1L solution each containing between chloroxylenol 1g right.
C.3 reference chromatographic conditions
Column. Cl 8 column (150mm × 4.6mm inner diameter, of 5 m); mobile phase. methanol/water (70/30), before analysis by 0.45μm membrane
Filter and vacuum degassing; flow rate. 1.00mL/min; detection wavelength. 220nm; column temperature. 25 ℃.
Draw standard curve C.4
With inter chloroxylenol Standard Solution concentrations were 0mg/L, 200mg/L, 400mg/L, 600mg/L and
800mg/L of standard series. In setting the chromatographic conditions, 5μL were taken for analysis. Standard series of concentration as the abscissa C,
Peak area for the vertical axis Y, linear regression, linear equations obtained.
C.5 sample determination
If chlorine disinfectant in the inter-xylenol marked concentration is too high, you need appropriate dilution, so that after dilution in the linear range of the standard curve
Inside. For paste samples should be used to match the flow of an aqueous solution. Through 0.45μm membrane filter back. Under chromatographic conditions set into
5μL of the sample solution for analysis. According to peak area, calculated from the linear equation corresponding xylenol between chlorine concentration right. According to the sample size and
Dilution, the final concentration in the sample in terms of inter-chloro-xylenol.
C.6 Notes
If you encounter some interference disinfectant, or the mobile phase can be adjusted in the mobile phase by adding suitable additives to achieve the best points
Alienation effect.
Appendix D
(Informative)
Determination of disinfectants in trichloro-2'-hydroxy-diphenyl ether content
D.1 Principle
2,4,4'-trichloro-2'-hydroxydiphenyl ether in UV absorption at 280nm there can be used phase high performance liquid chromatography (HPLC) separation, and in accordance with
Retention time qualitative and quantitative peak area. This method is applicable to the determination of disinfectant trichloro-2'-hydroxy-diphenyl ether active ingredient.
D.2 reagent preparation
Methanol (HPLC grade); trichloro-2'-hydroxy-diphenyl ether standard solution. Weigh trichloro-2'-hydroxy-diphenyl ether Standards
0.1g, with a small amount of methanol was dissolved and set the volume to 100mL, 1L each solution containing trichloro-2'-hydroxy-diphenyl ether 1g.
D.3 reference chromatographic conditions
Column. Cl 8 column (150mm × 4.6mm inner diameter, of 5 m); mobile phase. methanol/water (80/20), before analysis by 0.45μm membrane
Filter and vacuum degassing; flow rate. 1.5mL/min; detection wavelength. 280nm; column temperature. 25 ℃.
Draw standard curve D.4
Trichloro-2'-hydroxy-diphenyl ether with preparation of standard solution concentrations were 0mg/L, 200mg/L, 400mg/L,
600mg/L and 800mg/L of standard series. In setting the chromatographic conditions, 5μL were taken for analysis. Standard quality concentrated series
Abscissa degree C, peak area for the vertical axis Y, linear regression, linear equations obtained.
D.5 sample determination
If DISINFECTANT trichloro-2'-hydroxy-diphenyl ether marked concentration is too high, you need appropriate dilution, so that after dilution in the standard curve
Linear range. For paste samples should be used to match the flow of an aqueous solution. Through 0.45μm membrane filter back. Set chromatography
Under the conditions, the sample solution is analyzed into 5μL. According to peak area, calculated from the linear equation of the corresponding trichloro-2'-hydroxy-diphenyl
Ether concentration. According to the sample size and dilution, the final concentration in the sample in terms trichloro-2'-hydroxy diphenyl ethers.
Related standard:   GB/T 27947-2020  GB 27948-2020
Related PDF sample:   GB 27948-2020  GB 27949-2020
   
 
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