WS/T 326.2-2010 PDF English
US$105.00 · In stock · Download in 9 secondsWS/T 326.2-2010: Efficacy evaluation of toothpaste. Part 2: Guidelines for anti-caries efficacy evaluation Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| WS/T 326.2-2010 | English | 105 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Efficacy evaluation of toothpaste. Part 2: Guidelines for anti-caries efficacy evaluation
| Valid |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: WS/T 326.2-2010
WS/T 326.2-2010: Efficacy evaluation of toothpaste. Part 2: Guidelines for anti-caries efficacy evaluation
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/WST326.2-2010
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
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
4.2 Efficacy determination
4.2.1 According to 5.1 laboratory evaluation method of anti-caries efficacy,
after the experiment, when free fluorine or soluble fluorine content of fluoride
toothpaste is ≥ 500 mg/k, the product shall have anti-caries efficacy.
4.2.2 According to clinical trial requirements of 5.2 anti-caries efficacy, at
baseline, mid-trial, and at the end of the trial, respectively KEEP statistics on
the increase in the value of the indicators after the test for the experimental
group and the positive control group (fluoride toothpaste of total fluorine of 1100
mg/kg ~ 1450 mg/kg in accordance with this Standard, excluding other active
ingredients) and CARRY OUT the statistical analysis on the changes of each
index at any period between the two groups.
5 Evaluation method
5.1 Laboratory evaluation method
5.1.1 Determination of free fluoride or soluble fluorine content after fluoride-
containing toothpaste product aging test shall be carried out according to the
fluoride determination method specified in GB 8372.
5.2 Evaluation method of clinical trial
5.2.1 Principles for test design
Randomized, controlled, and blinded clinical trial methods should be used. The
test should be equipped with a positive control.
5.2.2 Duration of test
The test should be continued for at least 2 years. Caries status shall be checked
and recorded at baseline, at mid-trial, and at the end of the trial.
5.2.3 Test subject
5.2.4 Index checking or using
Crown caries. the use of decayed-missing-filled tooth (DMFT), distant
metastasis-free survival (DMFS), decayed-missing-filled tooth (dmft) and
distant metastasis-free survival (dmfs).
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
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
4.2 Efficacy determination
4.2.1 According to 5.1 laboratory evaluation method of anti-caries efficacy,
after the experiment, when free fluorine or soluble fluorine content of fluoride
toothpaste is ≥ 500 mg/k, the product shall have anti-caries efficacy.
4.2.2 According to clinical trial requirements of 5.2 anti-caries efficacy, at
baseline, mid-trial, and at the end of the trial, respectively KEEP statistics on
the increase in the value of the indicators after the test for the experimental
group and the positive control group (fluoride toothpaste of total fluorine of 1100
mg/kg ~ 1450 mg/kg in accordance with this Standard, excluding other active
ingredients) and CARRY OUT the statistical analysis on the changes of each
index at any period between the two groups.
5 Evaluation method
5.1 Laboratory evaluation method
5.1.1 Determination of free fluoride or soluble fluorine content after fluoride-
containing toothpaste product aging test shall be carried out according to the
fluoride determination method specified in GB 8372.
5.2 Evaluation method of clinical trial
5.2.1 Principles for test design
Randomized, controlled, and blinded clinical trial methods should be used. The
test should be equipped with a positive control.
5.2.2 Duration of test
The test should be continued for at least 2 years. Caries status shall be checked
and recorded at baseline, at mid-trial, and at the end of the trial.
5.2.3 Test subject
5.2.4 Index checking or using
Crown caries. the use of decayed-missing-filled tooth (DMFT), distant
metastasis-free survival (DMFS), decayed-missing-filled tooth (dmft) and
distant metastasis-free survival (dmfs).
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of WS/T 326.2-2010 be delivered?Answer: The full copy PDF of English version of WS/T 326.2-2010 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of WS/T 326.2-2010_English with my colleagues?Answer: Yes. The purchased PDF of WS/T 326.2-2010_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- WS/T 326.2-2010 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. How to buy and download a true PDF of English version of WS/T 326.2-2010?A step-by-step guide to download PDF of WS/T 326.2-2010_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "WS/T 326.2-2010".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|