This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Total fluoride content
4.2 Fluoride release potential
5 Sampling
6 Measurement and test methods
6.1 Test conditions
6.2 Test for total fluoride content
6.3 Tests for conformance with “Instructions for use” and “Packaging and labelling”
7 Test report
8 Instructions for use
9 Packaging and marking/labelling
9.1 Packaging
9.2 Marking/labelling
Annex A Test for fluoride release potential (informative)