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GB 15979-2002 English PDF (GB15979-2002)

GB 15979-2002 English PDF (GB15979-2002)

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GB 15979-2002: Hygienic standard for disposable sanitary products

This Standard specifies the hygienic standard for the products and production environment of disposable sanitary products, biological monitoring and evaluation criteria of disinfection efficacy and corresponding testing methods, hygienic requirements for the manufacturing, disinfection, storage and transport processes of raw materials and products, and product identification requirements.
GB 15979-2002
GB
NATIONAL STANDARD OF
THE PEOPLE REPUBLIC OF CHINA
ICS 11.080.10
C 48
Replacing GB 15979-1995
Hygienic standard for disposable sanitary products
ISSUED ON. MARCH 5, 2002
IMPLEMENTED ON. SEPTEMBER 1, 2002
Issued by. General Administration of Quality Supervision, Inspection and Quarantine of the PEOPLE Republic of China
3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 4
1 Scope ... 5
2 Normative references ... 5
3 Definitions ... 5
4 Hygienic indicators of products ... 6
5 Hygienic indicators of production environment ... 7
6 Biological monitoring evaluation of disinfection efficacy ... 7
7 Testing methods ... 8
8 Hygienic requirements for raw materials ... 8
9 Hygienic requirements for production environment and processes ... 8 10 Requirements for disinfection processes ... 10
11 Requirements for packaging, transport and storage ... 10
12 Product identification requirements ... 11
Annex A (Normative) Toxicological testing methods of products ... 12
Annex B (Normative) Microbiological testing methods of products ... 14 Annex C (Normative) Testing methods for bactericidal properties, antibacterial properties and stability of products ... 21
Annex D (Normative) Testing methods for ethylene oxide residue of products ... 27
Annex E (Normative) Sampling and testing methods for production
environment ... 30
Annex F (Normative) Biological monitoring and evaluation methods of
disinfection efficacy ... 32
Annex G (Normative) Medium and reagent preparation ... 34
Foreword
The full text of this Standard is mandatory.
Since the release of GB 15979-1995 Hygienic standard for disposable sanitary products in 1996, the manufacturing enterprises have made clear the hygienic requirements and objectives, and the administrative departments have also had the basis for supervision and monitoring, thereby playing a positive role in promoting the sound development of this industry and improving the hygienic level. In the meantime, with the development of product categories and
materials, some contents of this Standard need to be improved. Therefore, the revision of this Standard was proposed.
GB 15979-1995 has been substituted by this Standard since the date of
implementation.
Annex A to Annex G of this Standard are normative annexes.
This Standard was proposed by the Ministry of Health of the PEOPLE Republic of China.
Responsible drafting organizations of this Standard. Shanghai Center for Disease Control and Prevention; participating drafting organizations. Procter & Gamble (China) Co., Ltd, and Johnson & Johnson (China) Ltd.
Main drafters of this Standard. Shen Wei, Lu Min, Yang Hongping, Zhou Mi, Pan Xihe and Liu Yujing.
Hygienic standard for disposable sanitary products
1 Scope
This Standard specifies the hygienic standard for the products and production environment of disposable sanitary products, biological monitoring and
evaluation criteria of disinfection efficacy and corresponding testing methods, hygienic requirements for the manufacturing, disinfection, storage and transport processes of raw materials and products, and product identification
requirements.
In this Standard, disposable sanitary products refer to.
This Standard is applicable to the departments, institutions or individuals engaged in the production and sales of disposable sanitary products in China, and is also applicable to the departments, institutions or individuals distributing imported disposable sanitary products.
2 Normative references
The provisions in the following standard become the provisions of this Standard through reference in this Standard. At the time of publication of this Standard, all editions shown are valid. All standards will be revised and the parties using this Standard shall explore the possibility of using the latest edition of the following standard.
GB 15981-1995 Evaluating method and standard for the efficacy of
disinfection and sterilization
3 Definitions
The following definition is applicable to this Standard.
Disposable sanitary products
Referring to a variety of daily necessities that are discarded after use once, in direct or indirect contact with the human bodies and used to achieve the (antibacterial or antiseptic) purposes of physiological hygiene or health care. The products can be solid or liquid. For instance, disposable gloves or finger cots (excluding the medical gloves or finger cots), tissues, wet tissues, hygiene wipes, films for phones, hats, masks, underpants, women?€?s menstrual hygiene 7 Testing methods
7.1 Product testing methods
7.1.1 Product appearance. Visual inspection, in line with the provisions of Subclause 3.1 in this Standard.
7.1.2 Toxicological testing methods of products. SEE Annex A.
7.1.3 Microbiological testing methods of products. SEE Annex B.
7.1.4 Testing methods for bactericidal properties, antibacterial properties and stability of products. SEE Annex C.
7.1.5 Testing methods for ethylene oxide residue of products. SEE Annex D. 7.2 Sampling and testing methods for production environment. SEE Annex E. 7.3 Biological monitoring and evaluation methods of disinfection efficacy. SEE Annex F.
8 Hygienic requirements for raw materials
8.1 Raw materials shall be non-toxic, harmless and non-polluting. The
packages of raw materials shall be clean and clearly indicate the name, production organization, production date or production lot number of the inclusions. Raw materials that affect hygienic quality shall not be exposed. Raw materials with special requirements shall be marked with preservation
conditions and shelf life.
8.2 Raw materials that affect the hygienic quality of the products shall have corresponding testing reports or supporting materials, and if necessary, microbiological monitoring and corresponding measures shall be taken.
8.3 It is forbidden to use the discarded sanitary products as raw materials or semi-finished products.
9 Hygienic requirements for production environment
and processes
9.1 The surrounding environment of the production area shall be clean and tidy, with no garbage or breeding sites of mosquitoes, flies and other pests. Annex B
(Normative)
Microbiological testing methods of products
B1 Product acquisition and sample processing
At least 12 samples in minimum sales package are extracted from three
transport packages in the same lot number. 1/4 of the samples are used for testing, 1/4 of the samples are used for sample retention, and the other 1/2 of the samples (allowed for on-site storage) are used for re-testing if necessary. The minimum sales packages for sampling shall not be broken, and shall not be unpacked before testing.
The sterile method is used to unpack at least 3 packages for testing under Grade 100 purification conditions. TAKE samples from each package.
Accurately WEIGH 10g ?? 1g of samples. ADD to 200mL of sterile saline after cutting into pieces. MIX evenly. Saline solution is then prepared. For liquid products, stock solution is directly used as the sample solution.
If the tested samples contain a large number of absorbent resin materials and thus cannot absorb enough sample solution, the amount of diluent can be increased by 50mL each time, until it is able to absorb enough sample solution for testing. The dilution shall be adjusted accordingly during the calculation of the total number of bacterial colonies and the total number of fungal colonies. B2 Method for testing the total number of bacterial colonies and the
initial contaminating bacteria
This method is applicable to the testing of the initial contaminating bacteria and the total number of bacterial colonies (hereinafter collectively referred to as ?€?total number of bacterial colonies?€?) in the products.
B2.1 Operating procedures
After the natural sedimentation of the above saline solution, TAKE the
supernatant for colony counting. A total of 5 plates are inoculated. ADD 1mL of sample solution to each plate. POUR 15mL to 20mL of melting nutrient agar medium cooled to 45??C or so into each plate. MIX evenly. WAIT until agar clots. TURN over each plate. PLACE the plates at 35??C ?? 2??C for 48 hours of culture. CALCULATE the number of colonies on the plates.
B2.2 Result report
B3.2 Result report
Where lactose bile salt fermentation tube produces acid and gas, lactose ...

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