Overview - EN ISO 15087:2025 (Dentistry - Dental elevators)
EN ISO 15087:2025 specifies general requirements and test methods for metallic dental elevators and sets dimensional requirements for key elevator types: Warwick James, Cryer, Coupland, Bein and Flohr. This consolidated first edition replaces the earlier multi-part series (ISO 15087‑1 to ‑6) and is harmonized with ISO 4865‑1. It covers materials, mechanical properties, surface finish, leak and strength tests, marking, packaging and instructions for use.
Key topics and technical requirements
- Scope and device types: Defines dental elevators (instruments used for loosening/extracting teeth or roots) and specific dimensional designs for Warwick James, Cryer, Coupland, Bein and Flohr elevators.
- Materials: Working parts shall be made of martensitic stainless steel (grades a, g, c or f) in accordance with ISO 7153‑1, or other materials listed in ISO 21850‑1. Handle materials follow ISO 4865‑1.
- Hardness: Vickers hardness for the working part is specified as 480 HV1 to 720 HV1 (tested per ISO 4865‑1:2023, clause 5.4).
- Surface finish and handle design: Surface finish and measurement methods are aligned with ISO 4865‑1; handle shape is at the manufacturer’s discretion but must meet dimensional and finish requirements.
- Mechanical testing: Includes requirements and test methods for tensile strength, torque strength, and hollow-handle leak tests (including heated oil and ultrasonic test methods).
- Reprocessing: The standard includes requirements relating to resistance against reprocessing (cleaning, sterilization) and references ISO 17664‑1 for processing information.
- Marking, labelling and packaging: Requirements for traceability and user information, plus instructions for use, are specified.
Practical applications - who uses this standard
- Manufacturers of dental instruments: design, production and conformity assessment of elevators to meet EU/CEN and international market requirements.
- Dental clinics and procurement teams: verifying instrument specifications, safety and reprocessing suitability.
- Regulatory and conformity bodies: assessing compliance with hygienic and mechanical performance criteria.
- Sterilization services and CSSDs: implementing validated reprocessing workflows aligned with manufacturer instructions and ISO 17664‑1.
- Standards committees and test labs: adopting harmonized test methods (hardness, leak, torque/tensile).
Related standards
EN ISO 15087:2025 is essential for ensuring safe, durable and reprocessable dental elevators that meet recognized mechanical, material and dimensional benchmarks.
