Home Cart Quotation About-Us
www.ChineseStandard.net
SEARCH

WS/T 326.2-2010 PDF English

US$105.00 · In stock · Download in 9 seconds
WS/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 procedure
Status: Valid
Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
WS/T 326.2-2010105 Add to Cart Auto, 9 seconds. Efficacy evaluation of toothpaste. Part 2: Guidelines for anti-caries efficacy evaluation Valid

Similar standards

GB/T 36388   GB 18469   WS/T 326.3   

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.
Image 1     Image 2     Image 3     

Tips & Frequently Asked Questions:

Question 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+ countries

Question 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