EN ISO 18397:2025 PDF

Overview

EN ISO 18397:2025 - Dentistry: Powered scaler (ISO 18397:2025) defines requirements and test methods for air-powered and electrically powered scaler handpieces and scaler tips, including piezoelectric and magnetostrictive ultrasonic scalers. It covers devices operated as stand‑alone units or connected to dental units for use on patients, and includes specifications for manufacturers’ instructions, marking and packaging. This edition (2025) supersedes EN ISO 18397:2016 and was adopted by CEN members across Europe.

Key topics and technical requirements

The standard addresses functional, safety and performance aspects of powered scalers, including:

• Classification of scaler handpieces (air‑powered vs electrical‑powered).
• Materials and surface requirements to ensure biocompatibility and cleanability.
• Performance tests: output power, frequency, amplitude, stall effort, tip extraction/insertion forces, holding torque, tightening torque and breakage resistance.
• Operating conditions: air and water supply, cooling liquid delivery, electrical power supply and connectors.
• Environmental and mechanical requirements: drop test, temperature (housing rise and excessive temperature), vibrations and noise level.
• Resistance to reprocessing and leakage/ingress of water to support safe sterilization and multi‑use tips/handpieces.
• Electromagnetic compatibility (EMC) and usability/operating controls.
• Measurement and test methods: detailed apparatus and procedures for reproducible laboratory testing.
• Manufacturer information: required instructions for use, marking and packaging to support safe clinical use and regulatory compliance.

Applications and who uses this standard

EN ISO 18397:2025 is intended for:

• Manufacturers and product designers of ultrasonic and air‑driven dental scalers for product development and CE marking.
• Test laboratories and conformity assessment bodies conducting performance and safety testing according to standardized methods.
• Regulatory affairs and quality managers ensuring compliance with medical device regulations and national adoption.
• Dental clinics and procurement teams evaluating devices for safety, durability and compatibility with dental units and sterilization workflows.
• Clinical engineers and service technicians who require standardized specifications for connectors, air/water supply, and repair/reprocessing procedures.

Practical benefits include improved patient safety, consistent clinical performance, interchangeability of tips and reduced risk of device failures through standardized testing.

Related standards

• Standards on medical device sterilization, electrical safety and EMC testing are commonly referenced alongside EN ISO 18397:2025. Check national standards bodies for up‑to‑date normative references and harmonized documents.