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WS/T 326.2-2010 PDF English


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WS/T 326.2-2010: PDF in English (WST 326.2-2010)

WS/T 326.2-2010 WS HEALTH INDUSTRY STANDARD OF THE PEOPLE'S REPUBLIC OF CHINA ICS 11.020 C 05 Efficacy evaluation of toothpaste – Part 2. Guidelines for anti-caries efficacy evaluation ISSUED ON. DECEMBER 3, 2010 IMPLEMENTED ON. DECEMBER 3, 2012 Issued by. Ministry of Health of the People 's Republic of China Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Terms and definitions ... 4  4 Efficacy evaluation ... 4  5 Evaluation method ... 5  Foreword WS/T 326-2010 Efficacy evaluation of toothpaste consists of the following parts. - Part 1. General principles; - Part 2. Guidelines for anti-caries efficacy evaluation; - Part 3. Guidelines for efficacy evaluation on the control of dental plaque or gingivitis; - Part 4. Guidelines for efficacy evaluation on dentin hypersensitivity. This Part is the second part of WS/T 326. This Part refers to the American Dental Association (ADA) Guidelines for the Validation of Fluoride Toothpaste in the Guidelines for the Safety and Efficacy of Oral Health Products - “ Guidance on Acknowledgment of Fluoride Toothpaste by the American Dental Association Scientific Committee, November 2005”. This Part was proposed by Chinese Journal of Stomatology. This Part was approved by the Ministry of Health of the People's Republic of China. The drafting organizations of this Part. West China College of Stomatology of Sichuan University, Peking University School of Stomatology and Sun Yat-sen University Guanghua School of Stomatology. Main drafters of this Part. Hu Deyu, Wang Xiaoling, Wang Qin, Lin Huancai, Zhang Boxue. Efficacy evaluation of toothpaste – Part 2. Guidelines for anti-caries efficacy evaluation 1 Scope This Part of WS/T 326 specifies efficacy evaluation and evaluation method of anti-caries of toothpaste. This Part applies to toothpaste products that claim to have anti-caries efficacy and physical and chemical properties, health and safety indicators in line with the corresponding national standards. 2 Normative references The following referenced documents are indispensable for the application 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 8372 Toothpaste WS/T 326.1 Efficacy evaluation of toothpaste - Part 1. General principles 3 Terms and definitions For the purposes of this document, the terms and definitions specified in WS/T 326.1 apply. 4 Efficacy evaluation 4.1 Evaluation principle a) To verify the efficacy of dental fluoridation toothpaste, it should be carried out by the laboratory evaluation method required in 5.1. b) To evaluate the anti-caries efficacy of product containing non-fluoride, a clinical trial is carried out according to requirements of 5.2. 4.2 Efficacy determination ......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.