Overview
ISO 28158:2018 specifies requirements and test methods for integrated dental floss and handles intended for manual use in home, community or professional oral care. The standard covers design, material, mechanical strength, packaging, labeling and user instructions for devices where the floss is a fixed, integral part of the handle. It excludes devices with continuous supply floss or handles to which floss is later added, and it does not provide biological risk test methods (see ISO 10993-1 and ISO 7405).
Key topics and technical requirements
- Scope: Applies to integrated dental floss and handles for manual use in dental hygiene and part of dental treatment.
- Material and shape
- Floss and handle must be free from extraneous matter.
- No sharp surfaces, burrs or hazardous parts (except intended toothpick features).
- Strength
- Devices must withstand a load of 10 N without floss or handle breakage, pull-out of the floss, or a loading-point displacement greater than 10 mm.
- Strength may be demonstrated by either a static test (10 N for 10 s) or a tensile test using tensile-testing equipment.
- Test specimens are conditioned and tested at specified temperatures; visual inspection uses normal acuity and ×10 magnification where indicated.
- Sampling and pass/fail
- Representative specimens identical to the marketed product are tested; Annex A describes testing 10 specimens and a conformity rule (e.g., 8 of 10 passing).
- Packaging and labeling
- Packaging must prevent contamination.
- Required labelling: trade name, manufacturer/distributor name and address, and manufacturer’s tracking code.
- Instructions for use
- Must include tooth-cleaning directions and safety guidance (recommendation to use a gentle “sawing” or “zig‑zag” motion during insertion/removal to reduce gingival injury).
Applications and users
- Manufacturers and product designers of integrated dental-floss handles use ISO 28158:2018 to guide product design, testing and regulatory documentation.
- Quality assurance and testing laboratories apply the standard’s static and tensile test procedures to verify mechanical performance.
- Regulatory authorities and procurement professionals rely on the standard for product specifications and conformity assessment.
- Dental professionals and oral-care brands reference the standard when specifying safe, effective floss-handle products for patient or consumer use.
Related standards
- ISO 10993-1 (biological evaluation of medical devices)
- ISO 7405 (dental implants - biological evaluation)
- ISO 1942 (dentistry vocabulary)
- ISO 3696 (water for analytical laboratory use)
Keywords: ISO 28158:2018, integrated dental floss, dental floss and handles, dentistry standard, floss strength test, static test, tensile test, oral care device.