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WS/T 326.3-2010

Chinese Standard: 'WS/T 326.3-2010'
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BASIC DATA
Standard ID WS/T 326.3-2010 (WS/T326.3-2010)
Description (Translated English) Efficacy evaluation of toothpaste - Part 3: Guidelines for efficacy evaluation on the control of dental plaque or gingivitis
Sector / Industry Health Industry Standard (Recommended)
Classification of Chinese Standard C05
Classification of International Standard 11.020
Word Count Estimation 6,612
Date of Issue 2010-12-03
Date of Implementation 2010-12-03
Quoted Standard WS/T 326.1
Drafting Organization Peking University School of Stomatology
Administrative Organization ?PRC Ministry of Health
Regulation (derived from) ?Ministry of Health Announcement Health-Communication (2010) 25
Summary This standard specifies the inhibition of plaque assessment and evaluation methods and (or) reduce the efficacy of gingival inflammation. This section applies to claims that inhibit plaque by chemical action, alleviate gum inflammation, and physical and chemical properties, health and safety indicators in line with national standards for appropriate toothpaste products. Remove or reduce plaque by mechanical scavenging efficacy evaluation within the scope of this section.

WS/T 326.3-2010
WS
HEALTH INDUSTRY STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.020
C 05
Efficacy evaluation of toothpaste -
Part 3 . Guidelines for efficacy evaluation on
the control of dental plaque or gingivitis
牙膏功效评价 第3部分. 抑制牙菌斑和(或)减轻牙龈炎症
ISSUED ON. DECEMBER 3, 2010
IMPLEMENTED ON. JUNE 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 Clinical Trial Requirements ... 5 
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 3 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. School of Stomatology of Peking University, Huaxi
School of Stomatology of Sichuan University, School of Stomatology of Peking
University, and School of Stomatology of Shanghai Jiaotong University.
Main drafters of this Part. Cao Caifang, Hu Deyu, Zhang Boxue, Yang Shenhui, Liu
Xuenan, and Shu Chenbin.
Efficacy evaluation of toothpaste -
Part 3 . Guidelines for efficacy evaluation on the
control of dental plaque or gingivitis
1 Scope
This Part of WS/T 326 specifies the assessment and evaluation methods of inhibiting
dental plaque and (or) reducing the gingival inflammation efficacy.
This Part applies to the toothpaste products that claim, through chemical action,
inhibiting dental plaque and reducing gum inflammation; and of which the
physiochemical properties and health-safety indicators comply with relevant national
standards. The efficacy evaluation of removing or reducing plaque by mechanical
scavenging is not within the scope of this Part.
2 Normative References
The following document is essential for the application of this document. For the
documents cited with dates, only that edition applies to this document. For undated
references, the latest edition (including any amendments) applies to this document.
WS/T 326.1 Efficacy evaluation of toothpaste - Part 1. General principles
3 Terms and Definitions
The terms and definitions defined in Part 1 of WS/T 326 apply to this document.
4 Efficacy Evaluation
4.1 in two independent clinical trials, the experimental group is compared with the
control group; when the amount of plaque is reduced and statistically significant, then
it indicates that the subject product having inhibiting plaque efficacy.
4.2 In each clinical trial that adopts negative control or placebo control, compare all
final indexes’ values between experimental group and control group; each test shall
meet that (control - experiment) / control is ≥12%, and with a statistical significance.
Two tests shall meet that the arithmetic average of the percentage reduction is ≥15%;
this indicates that the subject product has the efficacy to reduce gingival inflammation.
d) There is open caries or mucosal lesions in oral.
e) Suffer from severe periodontitis.
5.4 Examination indicators
5.4.1 Adopt the plaque index (such as Turesky and other modified Quigley-Hein PI) to
record plaque coverage area and thickness. It shall focus to observe the plaque near
the gingival and interproximal area.
The severity of gingival inflammation shall mainly select the objective indicators that
reflect the bleeding gums, such as BI (bleeding index Mazza,......
Related standard:   WS/T 326.1-2010  WS/T 326.2-2010
   
 
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