Overview
ISO 6874:2015 - Dentistry - Polymer-based pit and fissure sealants - defines requirements and test methods for polymer-based dental sealants used to fill pits and fissures. It covers both self-curing (Class 1) and external-energy‑activated (Class 2) materials and specifies sampling, physical property tests, test conditions and manufacturer information required for safe and effective product use.
Key topics and technical requirements
- Classification
- Class 1: self-curing materials (initiator + activator).
- Class 2: external-energy-activated materials (e.g., visible light).
- Biocompatibility
- Guidance references ISO 10993 (biological evaluation) and ISO 7405; specific qualitative/quantitative biocompatibility tests are not included in ISO 6874 but these standards are recommended.
- Physical properties and limits
- Working time (Class 1): ≥ 40 s (determined by thermometry method).
- Setting time (Class 1): ≤ 5 min (recorded as time to peak temperature at 37 ± 1 °C).
- Depth of cure (Class 2): ≥ 1.5 mm for each shade supplied.
- Sampling and test procedure
- Sample: retail package(s) from same batch with at least 20 g material.
- Test environment: prepare/test at (23 ± 2) °C, humidity > 30%; if refrigerated, equilibrate to 23 ± 2 °C.
- Typical test apparatus: thermocouple-based mould (specimen well ~4 mm diameter × 4 mm high) for working/setting time; cylindrical mould (6 mm × 4 mm) for depth-of-cure tests.
- Reproducibility: five determinations are specified with clear pass/fail decision rules (e.g., at least four of five results meeting limits).
- Packaging, marking and instructions
- Manufacturers must provide packaging and user instructions (recommended energy sources for Class 2, handling, storage) and mark capsule/single-dose and outer pack information per Clause 7.
Applications and users
- Dental product manufacturers - design, validate and certify sealants to meet regulatory and market requirements.
- Test laboratories and QC teams - perform standardized working/setting time, depth-of-cure and sampling tests to demonstrate compliance.
- Regulatory bodies and procurement - evaluate documentation and test reports for product approval and tenders.
- Dental clinicians and purchasing managers - interpret manufacturer information for clinical handling, curing protocols and shade selection.
Related standards
Keywords: ISO 6874:2015, polymer-based pit and fissure sealants, dental sealants, working time, setting time, depth of cure, biocompatibility, dental materials standards.
