GB 15979-2024 Hygienic requirements for disposable sanitary products
1 Scope
This document specifies the hygienic requirements of raw materials, production process, product, as well as requirements for packaging, transportation storage and marking of disposable sanitary products, and describes the corresponding testing methods.
This document is applicable to disposable sanitary products for sale and use.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 2: 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, National Health Commission of the People's Republic of China)
Hygienic code for disinfectant product manufacturer [(Edition 2009) issued by the Ministry of Health of the People's Republic of China]
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
disposable sanitary products
disposable daily products that come into direct contact with human body, and are used for the purpose of human physiological hygiene or antibacterial or bacteriostatic
Note: It mainly includes women's menstrual hygiene products, fecal hygiene products (excluding toilet paper), hygiene wet wipes, antibacterial agents, bacteriostatic agents and other sanitary products.
3.2
hygiene wet wipes
wet wipes prepared by adding appropriate amount of production water and bactericidal ingredients on the carriers such as non-woven fabrics, fabrics, wood pulp composite fabrics, wood pulp papers to have cleaning and sterilizing functions to the treated objects (such as hands, skin, mucosae and ordinary object surfaces)
Note: Only hygiene wet wipes that come into direct contact with hands, skin, or/and mucous membranes are included.
[Source: WS 575- 2017, 3.2, modified]
3.3
antibacterial agent
preparations that come into direct contact with the intact skin or mucous membranes of the human body and have certain bactericidal (bacterial and yeast) effects, but are not intended to treat diseases or improve symptoms of skin or mucous membranes
Note: It does not include human feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anorectal and other specific parts.
3.4
bacteriostatic agent
preparations that come into direct contact with the intact skin or mucous membranes of the human body and have certain bacteriostatic (bacterial and yeast) effects, but are not intended to treat diseases or improve symptoms of skin or mucous membranes
Note: It does not include human feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anorectal and other specific parts.
3.5
production workshop
site for production and processing of disposable sanitary products
Note: Including ingredients room (area), production and processing room (area), sub-(filling) assembly room (area), inner packaging room (area), etc. Among them, the production workshop of the sub-assembly enterprise includes the sub-(filling) assembly room (area) and the inner packaging room (area).
[Source: Hygienic code for disinfectant product manufacturer (Edition 2009), Article 12, modified]
3.6
super absorbent materials
absorber that can absorb liquid water several times to hundreds of times its own mass, and has the ability to retain water and water storage after absorption
Note: The absorber is composed of polymer compounds, pulp and non-woven fabrics.
Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Hygienic requirements of raw materials
5 Hygienic requirements of production process
6 Hygienic requirements for the products
7 Test method
8 Packaging, transportation and storage
9 Marking
10 Implementation of this standard
Annex A (Normative) Test methods for hygienic requirements in the production environment
Annex B (Normative) Microbiological test methods for products
Annex C (Normative) Methods for test and evaluation of disinfection effect
Annex D (Normative) Method for determination of ethylene oxide residue in products
Annex E (Normative) Test methods for bactericidal performance, bacteriostatic performance and stability of products
Annex F (Normative) Toxicological test methods for products
Bibliography
