GB 15979-2024 PDF EnglishUS$605.00 · In stock · Download in 9 seconds
GB 15979-2024: Hygienic requirements for disposable sanitary products Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB 15979: Historical versions
Similar standardsGB 15979-2024: Hygienic requirements for disposable sanitary products---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB15979-2024GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.080 CCS C 59 Replacing GB/T 15979-2002 Hygienic Requirements for Disposable Sanitary Products Issued on. JUNE 25, 2024 Implemented on. JULY 1, 2025 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 1 Scope... 5 2 Normative References... 5 3 Terms and Definitions... 6 4 Hygienic Requirements for Raw Materials... 7 5 Hygienic Requirements for Production Process... 8 6 Hygienic Requirements for Products... 9 7 Test Methods... 12 8 Packaging, Transportation and Storage... 14 9 Marking... 14 10 Implementation of Standard... 14 Appendix A (normative) Test Methods for Production Environment Hygienic Requirements... 15 Appendix B (normative) Microbiological Test Method... 18 Appendix C (normative) Test and Evaluation Method for Disinfection Effect... 25 Appendix D (normative) Test Method for Ethylene Oxide Residue in Products... 26 Appendix E (normative) Test Methods for Bactericidal Performance, Bacteriostatic Performance and Stability of the Products... 30 Appendix F (normative) Toxicological Test Methods for the Products... 58 Bibliography... 60 Hygienic Requirements for Disposable Sanitary Products1 ScopeThis document specifies the hygienic requirements for raw materials, production process and products, as well as the requirements for packaging, transportation, storage and marking of disposable sanitary products, and describes the corresponding test methods. This document is applicable to disposable sanitary products sold and used.2 Normative ReferencesThe contents of the following documents constitute indispensable clauses of this document through the normative references in the text. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 191 Packaging - Pictorial Marking for Handling of Goods GB 5749 Standards for Drinking Water Quality GB/T 8939 Sanitary Absorbent Pads (panty liner) GB/T 15981 Evaluating Method for the Efficacy of Sterilization for Disinfection Equipment GB/T 26367 Hygienic Requirements for Biguanides Disinfectants GB/T 26369 Hygienic Requirement for Quaternary Ammonium Disinfectant GB/T 27741 Paper and Board - Determination of Migratable Fluorescent Whitening Agents GB/T 27947 Hygienic Requirements for Phenol Disinfectant GB/T 28004.1 Disposable Diapers - Part 1.Disposable Diapers for Baby GB/T 28004.2 Disposable Diapers - Part 1.Disposable Diapers for Adult GB/T 38496 Toxicological Procedures and Methods of Safety Evaluation for Disinfectant GB 38598 General Requirement for Label and Instruction Book of Disinfection Products GB 50073 Code for Design of Clean Room WS/T 10009 Test Methods of Disinfection Products Pharmacopoeia of the People’s Republic of China (National Medical Products Administration,4 Hygienic Requirements for Raw Materials4.1 Raw materials shall comply with the requirements of relevant specifications and standards for disinfection products and shall be non-toxic and harmless. The packaging of raw materials shall clearly indicate the name of the contents, production organization, production date or production batch No.; raw materials with special requirements shall indicate storage conditions and shelf life. 4.2 Discarded or used disposable sanitary products shall not be used as raw materials or semi- finished products. 4.3 The following prohibited substances must not be added to the raw materials. a) Drugs listed in Pharmacopoeia of the People’s Republic of China and their raw materials with the same name shall not be added to antibacterial (bacteriostatic) agents (disinfectants and antiseptics, traditional Chinese medicines and bacteriostatic agents are excluded, as well as pharmaceutical excipients and purified water); preparations used to generate active or passive immunity, such as. vaccines, serum or toxins and their products, and preparations used to diagnose immune status, protein and peptide preparations (except lysozyme and lysostaphin); prohibited chemical substances (except iodine) listed in Safety Technical Specifications for Cosmetics; other prohibited substances stipulated by the national health administrative department and other substances with a definite hazard to human health. b) Hygiene wet wipes and other disposable sanitary products with antibacterial (bacteriostatic) functions shall not contain antibacterial drugs, antifungal drugs, antiviral drugs, hormone drugs and their raw materials of the same name, etc., and other prohibited substances stipulated by the national health administrative department and other substances with a definite hazard to human health. c) Non-woven fabrics, fabrics or other raw materials shall not contain prohibited ingredients, for example, migratory fluorescent whitening agents.5 Hygienic Requirements for Production Process5.1 The purchase, storage, distribution and use of raw and auxiliary materials shall satisfy the product quality control requirements and comply with management system regulations. 5.2 The production environment hygiene indicator requirements are as follows. a) The air in the antibacterial (bacteriostatic) agent production workshop shall comply with the requirements of Hygienic Standard for Disinfection Product Production Enterprises, and the purification workshop shall comply with the requirements of GB 50073; the total number of colonies in the air of other disposable sanitary products production workshops shall be less than or equal to 2,500 CFU/m3 (the air sampler method) or shall be less than or equal to 16 CFU/(plate 5 min) (the plate exposure method). b) The total number of colonies on workbench surfaces that are in direct contact with unpackaged products shall be less than or equal to 20 CFU/cm2. c) The total number of colonies on the hands of workers who are in direct contact with unpackaged products shall be less than or equal to 300 CFU/hand (glove). 5.3 The initial contaminating bacteria of disinfection-grade disposable sanitary products shall be less than or equal to 10,000 CFU/g or CFU/mL. 5.4 Disinfection methods used for disinfection-grade disposable sanitary products shall be tested for disinfection effectiveness and shall comply with the following requirements. a) Ethylene oxide disinfection. the killing log value of Bacillus subtilis black variant (ATCC 9372) spores is greater than or equal to 3.00; b) Ionizing radiation disinfection. the killing log value of Bacillus pumilus E601 (ATCC 27142) spores is greater than or equal to 3.00; c) Pressure steam disinfection. the killing log value of Bacillus stearothermophilus the requirements of Appendix A. 7.1.2 The test method for initial contaminating bacteria shall comply with the requirements of Appendix B. 7.1.3 The test and evaluation method for the disinfection effect shall comply with the requirements of Appendix C. 7.2 Test Methods for Product Hygienic Requirements 7.2.1 The appearance of the product is determined through the methods of visual inspection and sniffing. 7.2.2 The pH of absorbent products, such as. sanitary napkins and sanitary pads, etc. shall be determined in accordance with the method of GB/T 8939.If there are corresponding determination standards on the pH of other products, conduct the determination in accordance with the methods in the corresponding standards. If there is no corresponding determination standard, conduct the determination in accordance with the method of WS/T 10009. 7.2.3 Migratory fluorescent whitening agent. sanitary napkins (pads) shall be determined in accordance with the method of GB/T 8939; diapers shall respectively be determined in accordance with the methods of GB/T 28004.1 and GB/T 28004.2; other sanitary products shall be determined in accordance with the method of GB/T 27741. 7.2.4 The test of lead, arsenic and mercury shall be carried out in accordance with the methods of Safety Technical Specifications for Cosmetics. 7.2.5 The test method for ethylene oxide residue in products shall comply with the requirements of Appendix D. 7.2.6 The test methods for bactericidal performance, bacteriostatic performance and stability of the products shall comply with the requirements of Appendix E. 7.2.7 Chlorhexidine gluconate and chlorhexidine acetate shall be determined in accordance with the methods specified in GB/T 26367 and relevant national standards; 2,4,4’-trichloro-2’- hydroxydiphenyl ether shall be determined in accordance with the methods specified in GB/T 27947 and relevant national standards; benzalkonium bromide and benzalkonium chloride shall be determined in accordance with the methods specified in GB/T 26369 and relevant national standards; the contents of other active ingredients shall be determined in accordance with the methods specified in WS/T 10009 and relevant national standards; those that cannot be determined using chemical determination methods will not be determined here. 7.2.8 The toxicological test methods for the products shall comply with the requirements of Appendix F. 7.2.9 The microbiological test methods for the products shall comply with the requirements of Appendix B.Appendix A(normative) Test Methods for Production Environment Hygienic Requirements A.1 Air Sampling and Test Methods A.1.1 Sample collection If the indoor area is less than or equal to 30 m2, set up three points on the diagonal. inside, middle and outside; the inside and outside points are 1.0 m away from the wall. If the indoor area is greater than 30 m2, set up five sampling points in the east, west, south, north and middle, and the surrounding four sampling points are 1.0 m away from the wall. The production enterprise may also increase the quantity and placement locations of culture media in accordance with the actual layout of the production lines. Air sampler method. choose from a six-stage impactor air sampler or other proven air samplers. When sampling, place the sampler at a height of 0.8 m ~ 1.5 m in the center of the room, operate in accordance with the sampler instruction manual, and each sampling time shall not exceed 30 minutes. Plate exposure method. when sampling, place a plate (with a diameter of 9 cm) containing nutrient agar culture medium at the sampling point (with a height of 0.8 m ~ 1.5 m), aseptically open the plate cover, place it upside down on the edge of the plate, expose the plate to the air for 5 minutes, then, cover the plate and send it for testing in time. The air sampler method is preferred for air sampling. A.1.2 Test of total number of bacterial colonies Before sampling, place the prepared nutrient agar culture medium at 36 C 1 C and incubate it for 18 ~ 24 hours. Take it out and check whether there is any contamination and remove the contaminated culture medium. Within 4 hours, send the collected petri plates to the laboratory, at 36 C 1 C, incubate them for 48 hours, observe the results, and count the number of colonies on the plates. The plate exposure method shall be reported as the average number of colonies per plate. CFU/(plate 5 min). For the air sampler method, the total number of colonies shall be calculated using Formula (A.1). Where, Y---the total number of bacterial colonies in the air, expressed in (CFU/m3); n---the number of colonies on each plate, expressed in (CFU); v---the sampling rate, expressed in (L/min); t---the sampling time, expressed in (min); 1,000---the conversion factor. A.2 Sampling and Test Methods for Workbench Surface and Worker’s Hand Surface A.2.1 Sample collection A.2.1.1 Workbench. place a sterilized specification board with an inner diameter of 5.0 cm 5.0 cm on the surface of the object under test, use a cotton swab soaked in sterile physiological saline (or corresponding neutralizer) to respectively smear it horizontally and vertically for 5 times, then, cut off or break off the part of the cotton swab that comes into contact with hands, and aseptically put the cotton swab into a sampling tube containing 10.0 mL of physiological saline (or corresponding neutralizer) and submit it for testing. A.2.1.2 Worker’s hands (gloves). ask the examinee to put his five fingers together, use a cotton swab soaked in physiological saline (or corresponding neutralizer) on the curved surface of the right finger, rub it back and forth from the root to the tip of the finger twice, then, cut off or break off the part of the cotton swab that comes into contact with hands, and put the cotton swab into a sampling tube containing 10.0 mL of physiological saline (or corresponding neutralizer) and submit it for testing. A.2.2 Test of total number of bacterial colonies Within 4 hours, send the collected samples to the laboratory. After thoroughly shaking and mixing (it is advisable to use a vortex oscillator to shake) each sampling tube, take 1.0 mL of the sample solution, put into sterilized plates, pour in the nutrient agar culture medium, inoculate each sample into two plates in parallel, culture them at 36 C 1 C for 48 hours, and count the number of colonies on the plates. The total number of colonies on the workbench surface shall be calculated using Formula (A.2). Where, Y1---the total number of colonies on the workbench surface, expressed in (CFU/cm2); Y0---the average number of colonies on the plates, expressed in (CFU); ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of GB 15979-2024 be delivered?Answer: The full copy PDF of English version of GB 15979-2024 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of GB 15979-2024_English with my colleagues?Answer: Yes. The purchased PDF of GB 15979-2024_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- GB 15979-2024 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.Question 5: Should I purchase the latest version GB 15979-2024?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB 15979-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.How to buy and download a true PDF of English version of GB 15979-2024?A step-by-step guide to download PDF of GB 15979-2024_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).Step 2: Search keyword "GB 15979-2024". Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart. Step 4: Select payment option (Via payment agents Stripe or PayPal). Step 5: Customize Tax Invoice -- Fill up your email etc. Step 6: Click "Checkout". Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively. Step 8: Optional -- Go to download PDF. Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice. See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9 |
