WS/T 326.2-2010 English PDF (WS/T326.2-2010)

WS/T 326.2-2010: Efficacy evaluation of toothpaste. Part 2: Guidelines for anti-caries efficacy evaluation
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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
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