Overview
EN ISO 17937:2015 - Dentistry - Osteotome is the CEN-adopted European version of ISO 17937:2015. It specifies requirements and test methods for osteotomes used in dentistry for bone compaction, internal sinus floor elevation, and jaw bone cleaving, and covers marking, labelling and instructions for use. The standard addresses three instrument types-sinutome, condenser, and chisel-and defines working-end shapes, shank forms, materials, and performance tests.
Key topics and requirements
- Scope and classification
- Defines osteotomes for dental implant site preparation and classifies them by type (sinutome, condenser, chisel) and shank form (straight or offset).
- Shapes and dimensions
- Specifies acceptable working tip shapes (e.g., cylindrical for sinutomes, conical for condensers) and dimensional characteristics of the working end and overall length.
- Materials
- Addresses acceptable materials for working ends and handles, consistent with dental-instrument requirements.
- Performance requirements and test methods
- Surface finish evaluation and resistance to reprocessing (sterilization cycles).
- Hardness testing referencing ISO 6507-1 (Vickers) and ISO 6508-1 (Rockwell).
- Connection tests for shank-to-handle integrity, including tensile and torque tests.
- Measurement tests for length and diameter of the working area.
- Marking, labelling and instructions
- Requirements for marking on the instrument, package labelling, and user instructions to ensure traceability and safe clinical use.
- Normative references
Applications and practical value
- Ensures consistent dimensions and mechanical performance of osteotomes used in dental implantology, sinus lifts and bone-splitting procedures.
- Guides manufacturers in design, testing and labelling to meet regulatory and clinical expectations for safety, durability and reprocessing compatibility.
- Helps dental clinics and procurement teams select instruments that meet recognized instrument standards for reliable clinical outcomes and infection control.
- Supports quality managers and conformity assessors in demonstrating compliance during audits and product approvals.
Who should use this standard
- Dental instrument manufacturers (design, production, QA)
- Regulatory and conformity bodies
- Clinical managers, sterilization departments and procurement teams
- Dental implant and oral surgery specialists seeking standardized instrument specifications
Related standards
Keywords: EN ISO 17937:2015, osteotome, dentistry, sinutome, condenser, chisel, sinus floor elevation, bone compaction, dental instrument standards, marking and labelling, hardness test, surface finish, reprocessing resistance.
