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WS/T 326.1-2010 Related PDF English

WS/T 326.1-2010 (WS/T326.1-2010, WST 326.1-2010, WST326.1-2010) & related versions
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WS/T 326.1-2010English105 Add to Cart 0-9 seconds. Auto delivery. Efficacy evaluation of toothpaste - Part 1: General principles WS/T 326.1-2010 Valid WST 326.1-2010
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WS/T 326.1-2010 WS HEALTH INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.020 C 05 Efficacy evaluation of toothpaste - Part 1. General principles ISSUED ON. DECEMBER 3, 2010 IMPLEMENTED ON. DECEMBER 3, 2010 Issued by. Ministry of Health of the People’s Republic of China Table of Contents Foreword ... 3  1 Scope ... 4  2 Terms and definitions ... 4  3 Efficacy evaluation scope... 4  4 General principles of efficacy evaluation ... 5  5 Clinical trial requirements ... 6  Foreword  WS/T 326-2010 "toothpaste effect evaluation" is divided into 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 is part 1 of WS/T 326. Clinical trials in this Part references to the clinical trial’s design principle guidelines "American Dental Association Scientific Committee - Accreditation Program - Clinical Trial Program Guide, 2003" that was formulated by American Dental Association (ADA). This Part was proposed by Chinese Stomatological Association. This Part was approved by Ministry of Health of the People's Republic of China. Drafting organizations of this Part. Huaxi School of Stomatology of Sichuan University, School of Stomatology of Peking University, and School of Stomatology of Capital Medical University. Main drafters of this Part. Hu Deyu, Cao Caifang, Wang Xiaoling, Yang Shenghui, and Liu Xuenan. Efficacy evaluation of toothpaste - Part 1. General principles 1 Scope    This Part of WS/T 326 specifies the definition of toothpaste effectiveness, efficacy evaluation’s scope and general principles, and clinical trial requirements. This Part applies to the toothpaste products which claim to have some effect, and of which the physiochemical properties and health-safety indicators comply with relevant national standards. 2 Terms and definitions  The following terms and definitions apply to this document. 2.1 efficacy of anti-caries The efficacy that the products, through inhibiting enamel demineralization or promoting the remineralization of teeth, achieve to control the formation of dental caries; or through reducing plaque bacterial and acid production so as to achieve to prevent the generation of dental caries. 2.2 efficacy of control dental plaque or gingivitis The efficacy that the products, through chemical composition, generate the inhibition of plaque and (or) reduction of gingival inflammation such as swelling and bleeding. 2.3 efficacy on dentin hypersensitivity The efficacy that the products have anti-dentin hypersensitivity symptoms (i.e. the chemical and physical stimulation such as cold, hot, sour, sweet, probing causes tooth to generate abnormal short and sharp pain) role. 3 Efficacy evaluation scope  Anti-caries efficacy, inhibiting dental plaque and (or) reducing the efficacy of gingival inflammation, anti-dentine hypersensitivity efficacy. method consistency. 5 Clinical trial requirements  5.1 When a product containing certain active ingredients is trialed for efficacy evaluation for the first time, it shall be carried out at least two independent clinical trials. 5.2 When a known-efficacy active ingredient is claimed to have new efficacy, it requires at least two additional independent clinical trials. 5.3 The products containing the same active ingredient which has been validated by clinical trial, shall prove its efficacy through the following methods. a) Fluoride toothpaste products. Adopt laboratory evaluation method to validate; or there is no statistical significance of difference BETWEEN two independent clinical trials of the subject product AND positive control. b) Non-fluoride toothpaste products. Adopt that the two independent clinical trials of the subject product is superior to the negative control or placebo control. ......

BASIC DATA
Standard ID WS/T 326.1-2010 (WS/T326.1-2010)
Description (Translated English) Efficacy evaluation of toothpaste - Part 1: General principles
Sector / Industry Health Industry Standard (Recommended)
Classification of Chinese Standard C05
Classification of International Standard 11.020
Word Count Estimation 5,536
Date of Issue 2010-12-03
Date of Implementation 2010-12-03
Drafting Organization School of Stomatology, Sichuan University Huaxi
Administrative Organization ?PRC Ministry of Health
Regulation (derived from) ?Health-Communication [2010] 25
Summary This standard specifies the definition of toothpaste efficacy, evaluate the efficacy of the scope and requirements of the general principles and clinical trials. This section applies to claims to have some effect, and the physical and chemical properties, health and safety indicators in line with national standards for appropriate toothpaste products.