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WS 575-2017 English PDF

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WS 575-2017: (Sanitary wipes hygiene requirements)
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PDF similar to WS 575-2017


Standard similar to WS 575-2017

GB 15979   GB/T 15981   WS/T 641   WS/T 798   WS/T 797   WS 283   

Basic data

Standard ID WS 575-2017 (WS575-2017)
Description (Translated English) (Sanitary wipes hygiene requirements)
Sector / Industry Health Industry Standard
Classification of Chinese Standard C59
Word Count Estimation 7,734
Date of Issue 2017-09-10
Date of Implementation 2018-03-01
Regulation (derived from) State-Health-Communication (2017) 15
Issuing agency(ies) National Health and Family Planning Commission of the People's Republic of China

WS 575-2017: (Sanitary wipes hygiene requirements)

---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.
Hygiene requirements for wet wipes ICS 11.080 C 59 WS People's Republic of China Health Industry Standard Hygienic requirements for sanitary wipes 2017-09-10 released 2018-03-01 implementation Issued by the National Health and Family Planning Commission of the People's Republic of China

Foreword

Chapter 4.4, 8.1, 9.1, 10.1, 10.3 and Chapter 12 of this standard are recommended clauses, and the rest are mandatory clauses. The main drafting organizations of this standard. Jiangsu Provincial Health Supervision Institute, China Center for Disease Control and Prevention, Environmental and Health Related Product Safety Institute, Shandong Provincial Health and Family Planning Supervision Institute, Heilongjiang Provincial Center for Disease Control and Prevention. The main drafters of this standard. Gu Jian, Zhang Wei, Li Tao, Yuan Qingchun, Zhang Yifan, Lin Ling, Shi Yuchang, Shen Jin, Zhang Liubo, Zhang Wen Sheng, Xu Shuishen, Lin Chunqiao, Song Hengzhi, Guo Chunlin, Sun Wen, Wang Zhongquan. Hygienic requirements for sanitary wipes

1 Scope

This standard specifies the raw material requirements, technical requirements, inspection methods, application scope, use methods, signs and packaging, Transportation and storage, labels and instructions, and precautions. This standard applies to the production, sale and use of sanitary wipes.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document. GB/T 191 Packaging, Storage and Transportation Graphic Mark GB/T 27728-2011 wet wipes GB 15979-2002 Hygienic standard for disposable sanitary products GB/T 26369-2010 Hygienic Standard for Quaternary Ammonium Disinfectants GB/T 27947-2011 Hygienic Standard for Phenolic Disinfectants Pharmacopoeia of the People's Republic of China (2015 edition) Standards for Management of Labels and Instructions for Disinfection Products (2005 Edition) Ministry of Health Disinfection technical specifications (2002 edition) Ministry of Health

3 Terms and definitions

The following terms and definitions defined in the "Disinfection Technical Specification" (2002 Edition) apply to this document. 3.1 Cleaning The process of removing dirt on the object being treated. 3.2 Hygiene wet wipes Use non-woven fabrics, fabrics, wood pulp composite fabrics, wood pulp paper, etc. as carriers, add appropriate amounts of raw materials such as production water and disinfectant to treat Objects (such as hands, skin, mucous membranes and the surface of ordinary objects) have cleansing and sterilizing wet wipes. 3.3 Production liquid Soaking liquid or spraying liquid directly added to the carrier during the production process.

4 Raw material requirements

4.1 Non-woven fabrics, fabrics or other raw materials should be clean, non-toxic, and comply with relevant national regulations. Recycled or discarded materials should not be used. It should contain banned ingredients such as mobile fluorescent whitening agent. 4.2 The antiseptic active ingredients of sanitary wipes for hands, skin, and mucous membranes (contains antiseptic active ingredients for cleaning) should use non-industrial grade ingredients. (Except for non-industrial grade), acute oral toxicity should be actual non-toxic or low-toxicity, non-mutagenic, heavy metal lead content < 40mg/L, Mercury content < 1mg/L, arsenic content < 10mg/L. The preservatives used should comply with the Pharmacopoeia of the People’s Republic of China or the original Material requirements, the flavors, skin care agents and other auxiliary materials used should meet the requirements of food or cosmetic raw materials. 4.3 The ingredients and their names listed in the second part of the Pharmacopoeia of the People’s Republic of China (except for disinfection and antiseptic categories, purified water) should not be added Raw materials and other prohibited substances specified by the national health and family planning administration. 4.4 The conductivity of production water should be ≤5.1μS/cm (25°C). 4.5 The packaging materials directly in contact with the product should be non-toxic, harmless, clean, and have sufficient firmness.

5 Technical requirements

5.1 Sensory traits The appearance should be neat and tidy, free from hair loss and swarf; free from abnormal odor and foreign matter. 5.2 Liquid content The weight ratio of liquid to carrier in sanitary wipes should be ≥1.7. Note. Except sanitary wipes whose carrier is wood pulp composite cloth and wood pulp paper. 5.3 Active ingredient content The content of active ingredients should comply with the content marked on the product label. Among them, the liquid limit of sanitary wipes for hands, skin, and mucous membranes The substances used should meet the requirements of Table 1. 5.4 pH The pH value of the extruded liquid of sanitary wipes for hands, skin and mucous membrane is 3.5-8.5. 5.5 Stability The validity period is ≥1 year. 5.6 Packaging tightness The packaging should be sealed, and there should be no leakage, air leakage or damage. 5.7 Metal Corrosion Index The liquid used for the production of sanitary wipes on the surface of metal objects should be basically non-corrosive to metals. 5.8 Microbiological indicators The total number of bacterial colonies in sanitary wipes ≤20CFU/g, coliforms, pathogenic pyogenic bacteria (including Pseudomonas aeruginosa, Staphylococcus aureus) Bacteria and hemolytic streptococcus), the total number of fungal colonies shall not be detected. 5.9 Indicators for killing microorganisms The killing rate of sanitary wipes to Escherichia coli and Staphylococcus aureus should be ≥90%. If it is marked to have a sterilization effect on fungi, it should be white The killing rate of Candida ≥90%; if it is marked to kill other microorganisms, the corresponding microorganism killing rate should be ≥90%. 5.10 Toxicological safety indicators When sanitary wipes for hands, skin, and mucous membranes are first put on the market, corresponding toxicological tests should be carried out, and the results should meet the requirements of Table 2. Table 2 Toxicological safety index requirements Repeated intact skin irritation test on the subject, vaginal mucosal irritation test a Acute eye irritation test b Skin allergy test c No irritation or mild irritation to hands and skin--none or very mild No irritation or mild irritation of the mucous membrane No irritation or very light irritation Note. "-" means no test is needed. a Sanitary wipes used for vaginal mucosa, if used occasionally or at intervals of several days, perform a vaginal mucosal irritation test; if used continuously, perform multiple vaginal adhesion tests. Membrane irritation test. b Used for sanitary wipes for mucous membranes other than vaginal mucosa. c Hygienic wipes for babies.

6 Inspection method

6.1 Sensory traits It is determined by visual inspection and sniffing. 6.2 Liquid content Follow the method in 6.3 of GB/T 27728-2011. 6.3 Active ingredient content Take enough samples of sanitary wipes, open the outer packaging, wear sterile gloves, squeeze the liquid in the sanitary wipes into a glass container, and squeeze out The amount of liquid should meet the relevant experimental requirements (the sterilizing factor with adsorption effect can be used for production liquid). 2,4,4,-Trichloro-2,-hydroxydiphenyl ether Measure according to the test method specified in Appendix D of GB/T 27947-2011; benzalkonium bromide and benzalkonium chloride are in accordance with GB/T 26369-2010 attached The test method specified in record A shall be determined; the content of other active ingredients shall be determined in accordance with the test method specified in the "Disinfection Technical Specification" and related standards Method for measurement, it is impossible to use chemical measurement method without measurement. 6.4 pH Prepare the test solution according to method 6.3, and proceed according to the method of "Disinfection Technical Specification" (2002 edition). 6.5 Stability According to the expiry date marked in the product label and instructions, in accordance with the Sterilization Product Stability Test in the "Disinfection Technical Specification" (2002 Edition) Determine the liquid content, active ingredient content or microbicide effect before and after storage by a prescribed method or related standard method. The liquid content is in accordance with 6.2 Method determination, the weight ratio of the liquid to the carrier in the sanitary wipes should be ≥1.7; the active ingredient content should be determined according to the method 6.3; With the chemical determination method, the microbial killing effect shall be determined according to the method 6.9. 6.6 Package tightness Follow the method in Appendix A of GB/T 27728-2011. 6.7 Metal corrosion The liquid used in the production of sanitary wipes on the surface of metal objects is in accordance with the "Disinfection Technical Specification" (2002 Edition) on the corrosion of disinfectants to metals The measurement method or related standards. 6.8 Microbiological indicators Open at least 2 packages used for testing with aseptic method under 100-level purification conditions, take samples from each package and weigh them accurately 10g±1g sample. After cutting, add it to sterilized normal saline containing the corresponding neutralizer and mix well to obtain a normal saline sample solution. no Corresponding neutralizers use membrane filtration to remove the influence of bactericidal components in the sample on the growth of microorganisms. The test method is in accordance with GB 15979-2002 The method in Appendix B is carried out. 6.9 Indicators for killing microorganisms According to the method in Appendix C of GB 15979-2002 or the method of quantitative bacterial killing test in "Technical Specification for Disinfection" (2002 Edition) Row. 6.10 Toxicological safety The acute eye irritation test uses sanitary wipes to squeeze out liquid, in accordance with the acute eye irritation test regulations in the "Disinfection Technical Specification" (2002 edition) Method to determine. For the preparation method of the extruded liquid of sanitary wipes, see 6.3; multiple complete skin irritation tests and vaginal mucosal irritation tests And skin allergy test using sanitary wet wipes products, in accordance with the "disinfection technical specifications" (2002 edition) in multiple complete skin irritation tests, Vaginal mucosal irritation test and skin allergy test shall be determined by the prescribed methods.

7 Application range

Sanitary wipes are suitable for cleaning and sterilizing hands, skin, mucous membranes and the surface of ordinary objects.

8 How to use

8.1 Open the package according to the method specified in the product manual, take out the sanitary wipes, wipe them, and discard them after use. After opening multiple packages Seal in time. 8.2 The action time for hands is ≤1min, the action time for intact skin and mucous membranes is ≤5min, when it is used on the surface of ordinary objects Time≤30min.

9 Marking and packaging

9.1 The packaging should be dust-proof, moisture-proof and sealed. 9.2 The packaging label should comply with the "Regulations on the Management of Sterilization Product Labels and Instructions" (2005 Edition), Meet the requirements of GB/T 191. 10 Transportation and storage 10.1 It can be transported by general means of transportation. 10.2 Transport vehicles should be dry and tidy, and should not be mixed with contaminated materials, toxic and hazardous substances; transport should be protected from sunlight, rain, and moisture. Do not throw away during transportation to avoid damage to the outer packaging. 10.3 It should be stored in a cool, ventilated, dry and clean room. 10.4 It should not be mixed with contaminated articles and toxic and hazardous substances. 11 Labels and instructions It shall comply with the relevant regulations of the "Administrative Regulations on Labels and Instructions for Disinfection Products" (2005 Edition), in which the content of active ingredients in the extrudate is not Method using chemical determination method to label its dosage. 12 Notes 12.1 Placed in a place where infants and young children cannot reach easily. 12.2 Use with caution if you are allergic to sanitary wipes for hands, skin, or mucous membranes. 12.3 If it has adverse effects on the object of use, stop using it or wipe it with clean water. 12.4 Multi-piece packages should be marked with the shelf life after opening.

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