YY/T 0823-2020 in English
VALIDFluoride compounds used for dental carious prevention
- Issued on:2020-02-26
- Implemented on:2021-03-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$175.00
本标准规定了牙科学氟化物防龋材料的性能要求及检验方法。
本标准适用于以氟化物为有效成分，用于预防龋齿的牙科材料。
Introduction
Background and significance of standard revision
YY/T 0823-2020 is the industry standard for dental fluoride anti-caries materials in my country, replacing the 2011 version of the standard, and mainly referring to ISO 17730:2014 (non-equivalent adoption). The new standard adds technical requirements for total fluoride content for products such as fluoride varnish, and improves the microbial limit detection method (based on the 2015 edition of the Pharmacopoeia), reflecting the current technical development needs in the field of oral preventive medicine.
Definition of Core Terms
| Term | Definition | Applicable Product Type |
|---|---|---|
| Soluble Fluoride | Fluoride ions soluble in water from water-soluble materials | Gels/liquids/foams, etc. |
| Fluoride paint | Coatable liquid materials containing fluoride | Resin-type products |
| Total Fluoride Content | Mass fraction of fluorine in resin-type products | Fluoride paint, etc. |
Comparison of Key Technical Requirements
Main differences between the 2011 and 2020 editions
| Items | 2011 edition | 2020 edition |
|---|---|---|
| Term definition | Not clearly defined | Three new core terms |
| Total fluorine content | Not required | New technical requirements |
| Microbiological testing | Old method | Updated according to the 2015 edition of the Pharmacopoeia |
Detailed explanation of the test method
Determination of total fluorine content (resin-type products)
AdoptFluoride ion selective electrode method, the key steps include:
- Sample dissolution: Use chloroform to dissolve the resin matrix
- Fluoride ion extraction: TISAB buffer extraction
- Calibration curve: 10-3-10-6 mol/L standard solution
- Result calculation: mass fraction = [mgF/g]/10000
Tolerance: Not exceeding ±10% of the nominal value
Implementation recommendations
Precautions for manufacturers
- The packaging label must include the chemical name and concentration of fluoride
- Water-soluble products should be labeled with the allowable deviation of soluble fluoride content
- Microbial testing requires the establishment of pharmacopoeial method validation documents
Clinical use recommendations
- Resin-type fluoride varnish needs to form a complete film after use
- The recommended contact time for water-soluble gel is ≥4 minutes
- Products with abnormal pH values need to be evaluated for tooth tolerance
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