This standard specifies the hygienic standards for the products and production environment of disposable sanitary articles, the biological monitoring and evaluating criteria and corresponding inspection methods of sanitizing effect as well as the hygienic requirements for the raw materials and the production, sanitization, storage and transportation processes of products and the requirements for identification of products.
In this standard, the disposable sanitary products are:
This standard is applicable to the departments, organizations or individuals engaged in the production and distribution of disposable sanitary products, and is also applicable to the departments, organizations or individuals distributing the imported disposable sanitary products.
Foreword I
1 Scope
2 Normative References
3 Definitions
4 Hygienic Indexes of Products
5 Hygienic Indexes of Production Environment
6 Biological Monitoring and Evaluation on Sanitizing Effect
7 Test Methods
8 Hygienic Requirements for Raw Materials
9 Hygienic Requirements for Production Environment and Process
10 Requirements for Sterilization Process
11 Requirements for Packing, Transportation and Storage
12 Requirements for Identification of Products
Annex A (Normative) Toxicology Test Method of Products
Annex B (Normative) Microbiological Test Methods for Products
Annex C (Normative) Test Methods of Bactericidal Performance, Bacteriostatic Performance and Stability of Products
Annex D (Normative) Testing Method of the ethylene oxide Residues Dose of Product
Annex E (Normative) Sampling and Testing Methods of Production Environment
Annex F (Normative) Assessment Method of Biological Monitoring for Disinfection Effect
Annex G (Normative) Culture Medium and Reagent Preparation