ISO 17730:2025 PDF

Name: ISO 17730:2025 — Dentistry — Fluoride varnishes
SKU: ISO 17730:2025
Price: 25 EUR
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Dentistry — Fluoride varnishes

Название (английский):

ISO 17730:2025

Dentistry — Fluoride varnishes

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 11
Дата публикации:: 2 сентября 2025 г.
Издание:: ISO IS 17730 edition 3 version 1
ICS:: 71.100.70

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Описание (английский):

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. This also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers. This document does not apply to fast acting topical fluoride products such as fluoride oral rinses.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 17730:2025 - "Dentistry - Fluoride varnishes" specifies requirements and test methods for fluoride-containing dental varnishes intended for topical application to the outer surfaces of teeth and fillings by dental health care workers. The standard covers total digestible fluoride content, a minimum soluble fluoride release potential, sampling, measurement procedures, and packaging and labelling (including instructions for use). It excludes fast-acting topical fluoride products such as fluoride oral rinses.

Key topics and technical requirements

Total fluoride content: Measured per validated methods (reference to ISO 19448). The declared fluoride content shall not deviate by more than ±20% from the package statement when tested.

Fluoride release potential: A minimum soluble fluoride release potential of 14.2 ng F/mm² is required. Annex A provides an example test method; other validated methods with similar sensitivity and accuracy are acceptable.

Measurement methods: Test procedures include dissolution of the varnish matrix, extraction of soluble fluoride into an aqueous phase (TISAB buffer), and quantification using a fluoride ion-selective electrode (F‑ISE). Test conditions are standardized (e.g., 23 °C ± 2 °C).

Sampling and test reporting: Tests are performed on retail-packaged product from the same batch with allowances for repeat tests. Detailed sample preparation, calibration, and calculation steps are specified to ensure reproducible results.

Packaging and labelling: Requirements include clear instructions for use, outermost packaging content, and labelling information relevant for safe and effective clinical application.

Safety and biological assessment: While specific biological test protocols are not included, the standard references ISO 10993-1 and ISO 7405 for toxicological and biological hazard assessment.

Applications and who uses this standard

ISO 17730:2025 is relevant for:

Manufacturers of fluoride varnishes - product formulation control, quality assurance, and labelling compliance.

Analytical and quality control laboratories - standardized test methods for fluoride content and release potential.

Regulatory authorities and procurement teams - product evaluation, conformity assessment, and market surveillance.

Dental health care professionals and dental clinics - understanding product specifications and instructions for clinical use.

Standards committees and researchers - harmonized test protocols for product comparison and development.

Keywords: ISO 17730:2025, fluoride varnishes, dentistry standard, fluoride release potential, total fluoride content, fluoride ion-selective electrode, varnish packaging and labelling.

ISO 17730:2025 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

SIST EN ISO 19448:2018

Dentistry - Analysis of Fluoride Concentration in Aqueous Solutions by use of Fluoride-Ion Selective Electrod…

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

SIST EN ISO 7405:2025

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025)

SIST EN ISO 3696:1998

Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)

ISO 6487:2015/Amd 1:2017

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SIST EN ISO 835:2007

Laboratory glassware - Graduated pipettes (ISO 835:2007)

BS ISO 19426-3:2018

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