1 Scope
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 individual engaged in the production and distribution of disposable sanitary products, and also is applicable to the departments, organizations or individual distributing the imported disposable sanitary products.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this standard. At time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this code are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below.
GB 15981-1995 "Evaluating Method and Standard for the Efficacy of Disinfection and Sterilization"
Foreword I
1 Scope 1
2 Normative References 1
3 Definitions 1
4 Hygienic Indexes of Products 2
5 Hygienic Indexes of Production Environment 4
6 Biological Monitoring and Evaluation on Sanitizing Effect 4
7 Test Methods 4
8 Hygienic Requirements for Raw Materials 5
9 Hygienic Requirements for Production Environment and Process 5
10 Requirements for Sterilization Process 6
11 Requirements for Packing, Transportation and Storage 6
12 Requirements for Identification of Products 7
Annex A (Normative) Toxicology Test Method of Products 8
Annex B (Normative) Microbiological Test Methods for Products 10
Annex C (Normative) Test Methods of Bactericidal Performance, Bacteriostatic Performance and Stability of Products 15
Annex D (Normative) Testing Method of the ethylene oxide Residues Dose of Product 19
Annex E (Normative) Sampling and Testing Methods of Production Environment 21
Annex F (Normative) Assessment Method of Biological Monitoring for Disinfection Effect 23
Annex G (Normative) Culture Medium and Reagent Preparation 24
