Overview
EN ISO 28158:2018 - Dentistry: Integrated dental floss and handles specifies requirements and test methods for manually used integrated dental floss and handles intended for home, community or professional oral care. Adopted by CEN as EN ISO 28158:2018 (ISO 28158:2018), the standard covers design, mechanical strength, packaging, labelling and user instructions for integrated floss-and-handle devices - but excludes products with continuous floss supplies or detachable floss added after manufacture. Biological risk testing is excluded (see ISO 10993-1 and ISO 7405).
Key topics and requirements
- Scope and definitions
- Applies to integrated dental floss and handles for manual use; defines “dental floss” and “integrated dental floss and handle.”
- Material and shape
- Devices must be free from extraneous matter and have no sharp surfaces or burrs (×10 magnification inspection), except intentional toothpick parts.
- Mechanical strength
- Two accepted test methods:
- Static test (Annex A): withstand a 10 N static load for 10 s without floss or handle breakage, pull-out, or >10 mm displacement of the loading point.
- Tensile test (Annex B): alternative using tensile/testing equipment; must withstand 10 N without breakage, pull-out or >10 mm displacement.
- Sampling and test conditions
- Sample representative marketed products.
- Test temperature: (23 ± 5) °C.
- Visual inspections: normal acuity for cleanliness; ×10 magnification for shape.
- Packaging and labelling
- Packaging must prevent contamination.
- Package labelling must include trade name, manufacturer/distributor name and address, and manufacturer’s tracking code.
- Instructions for use
- Devices must include user instructions and recommended technique; standard recommends a gentle “sawing” or “zig-zag” motion during insertion/removal to reduce gingival injury.
Applications and practical value
- Manufacturers and product developers
- Use the standard to design compliant integrated floss-and-handle products, verify mechanical robustness, and prepare required labelling and instructions.
- Quality assurance and regulatory
- Implement test methods (static/tensile) and sampling procedures for product release and conformity assessment in markets adopting EN ISO 28158:2018.
- Dental professionals and procurement
- Evaluate product claims and ensure devices meet recognized strength and safety criteria for patient/home use.
- Test laboratories
- Execute the normative test methods (Annex A and B) and visual inspections under specified conditions.
Related standards
EN ISO 28158:2018 is essential for ensuring safety, mechanical reliability and clear user guidance for integrated dental floss and handles in the dental and oral-care market.
