WS/T 646-2019 English PDF

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WS/T 646-2019: Hygienic requirement for sodium percarbonate disinfectant
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Basic data

Standard ID: WS/T 646-2019 (WS/T646-2019)
Description (Translated English): Hygienic requirement for sodium percarbonate disinfectant
Sector / Industry: Health Industry Standard (Recommended)
Classification of Chinese Standard: C59
Classification of International Standard: 11.080
Word Count Estimation: 11,116
Date of Issue: 2019
Date of Implementation: 2019-07-01
Issuing agency(ies): National Health Commission

WS/T 646-2019: Hygienic requirement for sodium percarbonate disinfectant

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Hygienic requirement for sodium percarbonate disinfectant ICS 11.080 C 59 WS People's Republic of China Health Industry Standard Sodium percarbonate disinfectant hygiene requirements Published on.2019 - 01 - 30 2019 - 07 - 01 implementation National Health and Wellness Committee of the People's Republic of China

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was drafted. Hunan Provincial Center for Disease Control and Prevention, China Center for Disease Control and Prevention, Environmental and Health-related Product Safety Institute, Shanghai Disinfection Products Association, Anhui Academy of Medical Sciences, Hunan Provincial Health and Family Planning Supervision Bureau, Zhangjiajie City Center for Disease Control and Prevention. The main drafters of this standard. Chen Guiqiu, Chen Peihou, Li Tao, Zhang Liubo, Xue Guangbo, Li Hua, Xu Qinghua, Li Aibin, Lin Biao, Zhong Ji Bo, Chen Yanhua, Zhu Yingkai, Song Jiangnan, Gao Qiong, Yin Jin, Yi Liang, Li Shikang, Nie Xinzhang, Tan Yuxing, Zhong Cunren, Han Li, Ji Hua Kui, Zhu Si, Sun Wen. Sodium percarbonate disinfectant hygiene requirements

1 Scope

This standard specifies the raw material requirements, technical requirements, application range, use methods, transportation, storage and packaging of the sodium percarbonate disinfectant. Identify requirements and test methods. This standard applies to disinfectants with sodium percarbonate as the main raw material.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 packaging storage and transportation icon Disinfection product label specification management regulations Ministry of Health (Wei Supervision issued [2005] No. 426) Disinfection Technical Specification (2002 Edition) Ministry of Health (Wei Jian Jian Fa [2002] No. 282)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Sodium percarbonate disinfectant Made with sodium percarbonate (also known as sodium percarbonate) as the main raw material, with a small amount of peroxyacid precursor and appropriate excipients, Chemicals for disinfecting effects. 3.2 Precursor precursor An organic compound having an acyl structure.

4 raw material requirements

Sodium percarbonate meets the requirements of the corresponding standards. Other auxiliary ingredients meet the quality requirements of the relevant standards.

5 Technical requirements

5.1 Physical and chemical indicators 5.1.1 sodium percarbonate content Mass content (based on active oxygen [O]) ≥ 11%. 5.1.2 The mass content of the precursor 1.5% to 3.0%. 5.1.3 pH value The pH of the dilution containing 1.0% sodium percarbonate disinfectant is 8-11. 5.1.4 Stability Validity period ≥ 12 months. 5.2 Killing microbial indicators According to the disinfection technical specification (2002 edition) method, the suspension quantitative quenching test is carried out according to the concentration and action time of the product instruction manual. The test or carrier quantitative sterilization test, the results of killing microorganisms should meet the requirements of Table 1. Table 1 Technical requirements for killing microorganisms Microbial species Killing the logarithm Suspension carrier method E. coli 8099 ≥ 5.00 ≥ 3.00 Staphylococcus aureus ATCC6538 ≥ 5.00 ≥ 3.00 Other bacterial propagules in the instruction manual ≥ 5.00 ≥ 3.00

6 Application range

Suitable for disinfection of common object surfaces, environments, fabrics and sewage.

7 How to use

7.1 Disinfection of ordinary objects surface, environment and fabric 7.1.1 Soaking method Immerse the cleaned items to be immersed in a container containing 0.5% to 1.0% sodium percarbonate dilution and cover, soak and disinfect for 30 minutes. After disinfection, rinse with water to remove residual disinfectant. 7.1.2 Wiping method For large items or other items that cannot be sterilized by soaking, use 0.5% to 1.0% sodium percarbonate dilution to wipe and disinfect. After using for 30 minutes, wipe or wash with water after disinfection to remove residual disinfectant. 7.1.3 Spraying method Spraying (fog) the surface of ordinary objects (environment) with 0.5% to 1.0% sodium percarbonate dilution for 30 minutes, disinfecting Afterwards, wipe or wash with water to remove residual disinfectant. 7.2 Disinfection of sewage The sewage is added with 0.1% sodium carbonate disinfectant according to 0.1%, and the disinfection effect can be achieved by disinfecting for 30 minutes. 8 Transportation, storage and packaging 8.1 Transportation The shipping container should be anti-corrosion, and should be sealed when transported. It should be covered to prevent sun, rain and moisture; it should not be mixed with reducing agent and acid. Transportation; loading and unloading should be light and easy to throw. 8.2 Storage Store in a cool, dry, ventilated and dark place to prevent rain, moisture, and sunlight; the packaging should be tight, and the stacking mat should be 10cm away from the ground. Above, keep the distance from the wall surface 20cm, the limit height of the storage stacking layer should not be higher than 10 bags; not mixed with reducing agent and acid substances. 8.3 Packaging The packaging and transportation pictorial signs shall comply with the requirements of GB ∕T l91.

9 Identification requirements

9.1 Labels and instructions Comply with the "Management Specifications for Labeling Instructions for Disinfecting Products". 9.2 Precautions 9.2.1 External disinfectant to avoid oral administration; avoid prolonged contact between the product and eyes and skin. 9.2.2 Store in a cool, dry, ventilated place and out of reach of children. 9.2.3 Not mixed with chlorine bleach, bleaching liquid, acid and reducing agent. 9.2.4 For fabric disinfection, bleaching and corrosive, use with caution. 10 Test methods 10.1 Inspection rules The factory inspection items are active oxygen, pH and precursor content detection; type inspection is for all items. 10.2 Content detection Test with active oxygen, see Appendix A for the method. 10.3 Precursor content detection For the determination of tetraacetylethylenediamine content, see Appendix B for the method. 10.4 pH detection Tested according to the disinfection technical specification (2002 edition) 10.5 Stability test The measurement was carried out according to the disinfection technical specification (2002 edition). 10.6 Killing microbial test The measurement was carried out according to the disinfection technical specification (2002 edition). AA

Appendix A

(normative appendix) Active oxygen detection method A.1 Principle Sodium percarbonate disinfectant dissolved in water to decompose into sodium carbonate and hydrogen peroxide, neutralize sodium carbonate with sulfuric acid and make the solution acidic, in acidic conditions Under the hydrogen peroxide and potassium permanganate redox reaction, according to the consumption of potassium permanganate titration solution, to ensure the content of reactive oxygen, reaction The formula is as follows. 2KMnO4 3H2SO4 5H2O2 =K2SO4 2MnSO4 5O2↑ 8H2O A.2 reagent A.2.1 Sulfuric acid solution. 1+3. A.2.2 Potassium permanganate standard titration solution. c (1/5KMnO4) ≈ 0.1mol/L. A.3 Operation steps Approximately 5 g of the sample was weighed to the nearest 0.0002 g and placed in a 250 mL beaker. Wet with a small amount of water, add about 25mL sulfuric acid solution to make the sample All dissolved. Transfer the test solution to a 500 mL volumetric flask, dilute to the mark with water, and shake well. Pipette 20mL test The solution was placed in an Erlenmeyer flask and titrated with a potassium permanganate standard titration solution until the solution became pink, and the end point was not disappeared within 30 s. with A blank test was performed. The blank test should be performed in parallel with the assay and the same analytical procedure should be used to take the same amount of all reagents (standard drop) Except for the fixed solution), but the blank test does not add a sample. A.4 Calculation of results The active oxygen content is expressed as the mass fraction W1 of oxygen (O), and the value is expressed in %, calculated according to the formula (A.1). W1= 500/20 ]1000/)[( 0 cMVV ×100% ...(A.1) In the formula. The volume of the potassium permanganate standard titration solution consumed by the V-titration test solution, in milliliters (mL); The volume of the potassium permanganate standard titration solution consumed by the V0-blank test, in milliliters (mL); c The exact value of the concentration of potassium permanganate standard titration solution, in moles per liter (mol/L); m a sample quality value in grams (g); The value of the molar mass of M-oxygen (1/2O) in grams per mole (g/mol) (M = 7.999). The arithmetic mean of the parallel determination results is the measurement result, and the absolute difference between the two parallel determination results is not more than 0.1%. BB

Appendix B

(normative appendix) Determination of tetraacetylethylenediamine (TAED) content in sodium percarbonate disinfectant (gas chromatography) B.1 Principle The content of tetraacetylethylenediamine (TAED) in sodium percarbonate disinfectant was determined by internal standard method of gas chromatography, and the sample was dissolved in acetonitrile to prepare a solution. The internal standard is added to the solution, injected into a gas chromatograph, separated by a capillary column, and detected by a flame ionization detector (FID), according to The retention time was qualitative, and the response factor and peak area were compared quantitatively. B.2 Reagents and materials Acetonitrile (C2H3N). analytically pure; Carrier gas. for chromatography; Auxiliary carrier gas. for chromatography; Organic phase microporous membrane. 0.45 μm. B.3 Standards Methyl stearate (C19H38O2, CAS No.. 112-61-8). purity ≥ 99.0%; Tetraacetylethylenediamine (C10H16O4N2, CAS No.. 10543-57-4). purity ≥ 99.0%. B.4 Instruments and equipment B.4.1 Gas phase chromatograph. with flame ionization detector (FID). B.4.2 Elastic quartz capillary column. It is recommended to use 100% dimethylpolysiloxane as a fixed liquid elastic quartz capillary column (25m x 0.25 mm, 0.25 μm df), or other equivalent column that satisfies the separation characteristics of B.5. B.4.3 Analytical balance. Sensitivity 0.1 mg or 0.01 mg. B.4.4 Grinding homogenizer. B.5 Instrument reference conditions Carrier gas. hydrogen or helium @15 psig pressure at a flow rate of 50 mL/min. Injector. Split/splitless injector. Injection volume. 1.5μl Injector temperature. 250 °C. Detector temperature. 300 °C. Heating program. 150 ~ 220 ° C, temperature increase at 10 ° C/min; 220 ~ 300 ° C, at 15 ° C/min speed. B.6 Analysis steps B.6.1 Sample preparation Weigh about 50 g of the sample to be tested, grind and mix with a grinding homogenizer, and set aside. B.6.2 Calibration B.6.2.1 Preparation of internal standard solution Accurately weigh about 250mg (accurate to 0.1mg) methyl stearate, put it in a 100mL volumetric flask, dilute with acetonitrile and make up to volume, fully mixed uniform. B.6.2.2 Preparation of standard solution Accurately weigh 25mg, 50mg, 75mg, 100mg 4 parts of TAED standard material (accurate to 0.1mg), respectively placed in a 20mL volumetric flask In the middle, accurately add 20mL of the internal standard solution to dissolve the sample. B.6.2.3 Determination of response factor RF The chromatographic operating conditions of B.5 are typical operating parameters. The analyst can adjust the operating parameters according to the characteristics of the instrument to obtain Get the best results. After the baseline of the instrument is stabilized, 1.5 μl of the standard solution is injected into the gas chromatograph, and the chromatogram is recorded. Each standard solution is repeated 3 Times. A typical chromatogram obtained is shown in Figure B.1.

1 TAED

2 methyl stearate (internal standard) 3 voltage, mv 4 time, min Figure B.1 Typical gas chromatogram of a 50mg TAED standard solution Calculate the peak area of TAED and internal standard in each chromatogram, and obtain the calibration standard by (AIS/AI) pair (mIS/mI) linear regression analysis curve. The response factor of the TAED relative to the internal standard is the slope of the calibration standard curve. If the correlation coefficient is less than 0.98, reconstitute Standard solution and determination. Or use the formula (B.1) to calculate each chromatographic response factor RFi. RFi=(AIS×mI)/(AI×mIS) ...(B.1) In the formula. AI- is the peak area of TAED in the standard solution; AIS- is the peak area of methyl stearate in the standard solution; mI- is the mass of TAED in the standard solution, mg; mIS- is the mass of methyl stearate in the standard solution, mg. The response factor RF is the average of all RFi. If the relative standard deviation of the RF is greater than 3%, repeat the calibration procedure and refill. Note. Do not need to do multi-point calibration every time you measure the sample, but use 50mg TAED plus 20mL internal standard solution before each test. A single point calibration is required, and the response factor should differ from the average of the multipoint calibration by less than 0.5%. B.6.3 Determination B.6.3.1 Preparation of sample solution Approximately 500 mg (accurate to 0.1 mg) of sample (m) was weighed into a 100 mL volumetric flask. Add 250mg (accurate to 0.1mg) stearic acid The ester was diluted with acetonitrile and brought to volume, and thoroughly mixed. If the solution is cloudy, it is filtered through a 0.45 μm microporous membrane. B.6.3.2 Determination of sample content Under the above chromatographic operating conditions, 1.5 μl of the sample solution was pipetted directly into the gas chromatograph using a micro-syringe, and the chromatogram was recorded. Repeat 2 times. A typical chromatogram is shown in Figure B.1. B.7 Calculation results The mass percentage of TAED in the sample, w(C10H16O4N2), calculated according to formula (B.2). W(C10H16O4N2)=(RF×mIS×AS×100)/(m×AIS) (B.2) In the formula. RF-response factor; The mass of methyl stearate in the mIS-sample solution, in milligrams; M-sample mass in milligrams; AIS - the peak area of methyl stearate in the sample solution; Peak area of TAED in AI-sample solution. B.8 Allowable error The absolute difference between the two measurements obtained under repetitive conditions shall not be greater than 10% of the average. ......

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