ISO 6874:2015

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

• ISO 10993 (biocompatibility evaluation)
• ISO 7405 (dental materials biocompatibility)
• ISO 1942 (dentistry vocabulary)
• ISO 10650 (dental curing light evaluation)
• ISO 8601 (date/time formats)

Keywords: ISO 6874:2015, polymer-based pit and fissure sealants, dental sealants, working time, setting time, depth of cure, biocompatibility, dental materials standards.