ISO 17730 pdf download

ISO 17730 pdf download Dentistry — Fluoride varnishes
This International Standard specifies requirements and their test methods for total digestible fluoridecontent in dental varnishes containing fluoride, intended for use in the oral cavity directly on theouter surfaces of teeth and fillings. lt also specifies the requirements for their packaging and labellingincluding the instructions for use. This International Standard covers fluoride varnishes to be appliedby dental health care workers.
2 Normative references
The following documents,in whole or in part, are normatively referenced in this document and areindispensable for its application, For dated references, only the edition cited applies. For undatedreferences, the latest edition of the referenced document (including any amendments) applies.
ISO 1942 Dentistry- Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8601, Data elements and interchange formats — Information interchange — Representation of datesand times
3Terms and Definitions
For the purposes of this document, the definitions given in ISO 1942 and the following apply.
3.1
consumer packaging
retail packagingsales packagingpackage, with labelling and contents as a sales unit to the user or consumer at the point of retail
Note 1 to entry: A consumer packaging can consist of a secondary packaging wrapping or container coveringone or more primary packaging elements or, it can consist of a single primary packaging element containing theproduct.
Note 2 to entry: Adapted from ISO 21067:2007 definition 2.2.5
3.2
fluoride varnish
dental product,in paintable liquid form containing fluoride compound for topical application to theouter surfaces of teeth and fillings, intended primarily to prevent tooth caries or reduce dentinehypersensitivity
3.3
total fluoride
mass percent of fluoride in the fluoride varnish
4 Requirements
4.1 Total fluoride content
The total fluoride content shall not deviate by more than 20 % from the stated amount on the packagewhen tested in accordance with 6.1 or other validated methods for total fluoride content
5 Sampling
Use packages prepared for retail sale from the same batch containing enough material to carry out thespecified tests, plus an allowance for repeat tests, if necessary.
6 Test method
6.1 Test for total fluoride content
6.1.1 Chemicals and solutions
6.1.1.1 Total ionic strength adjusting buffer (TISAB) solution, described in ASTM D1179-10:2010181 or alternative.
NOTETISAB Il: Sodium chloride 5,8 % (w/v), acetic acid 5,7 % (w/v), CDTA 0,4 % (w/v) adjust to pH 5 topH 5,5 with sodium hydroxide (5 mol/L).Examples are TISAB l (Orion Research).An acceptable product(TISABI0) is available from Thermo Fisher Scientific, Beverly, MA 01915 USA. This information is given only for theconvenience of users ofthis document and does not constitute an endorsement by lSO of this product.
6.1.1.2 50 % Diluted TISAB solution, dilute TISAB with deionized water 1:1 by volume
6.1.1.3 Fluoride standard solution, commercially available or prepared with sodium fluoride at010 mol/L.
6.1.1.4 Chloroform, reagent grade.