SIST EN ISO 14457:2018 PDF

Overview - EN ISO 14457:2017 (Dentistry: Handpieces and motors)

EN ISO 14457:2017 (ISO 14457:2017) is the European adoption of the international standard that specifies requirements and test methods for dental handpieces and motors that have patient contact. It sets performance, safety and information requirements regardless of handpiece construction and also covers manufacturer’s information, marking and packaging. The document was prepared by ISO/TC 106 “Dentistry” in collaboration with CEN/TC 55 and supersedes the 2012 edition.

Applicable device types:

• Straight and angle handpieces
• High‑speed air turbine handpieces
• Air motors
• Electrical motors
• Prophy (polishing) handpieces

Not applicable to:

• Intraoral camera handpieces
• Powered polymerization handpieces
• Air- or electrical-powered scalers
• Powder jet handpieces
• Multifunction syringes

(See Annex A of the standard for clarifications.)

Key topics and technical requirements

EN ISO 14457:2017 defines measurable and testable requirements to ensure safe, reliable dental handpieces and motors. Key topics include:

• Materials and surfaces - biocompatibility and cleanability considerations
• Resistance to reprocessing - autoclave/sterilization and durability testing
• Drop and ingress tests - mechanical robustness and water leakage
• Noise level, vibrations and temperature - patient and operator safety (temperature rise, excessive heat)
• Power, air and water supply requirements - electrical, air and water pressure specifications and test procedures
• Speed, stall torque, eccentricity and output power - performance metrics for motors and turbines
• Chuck systems and mandrels - shank retention, extraction and torque tests
• Electromagnetic compatibility (EMC) and usability of controls
• Marking, packaging and manufacturer information - required labelling and instructions for safe use

The standard includes detailed test methods, sampling and test conditions (see clauses on apparatus and procedures for air/water supply, cooling, spray systems).

Applications - who uses EN ISO 14457:2017

• Manufacturers of dental handpieces and motors use the standard to design, test and declare conformity for product safety and performance.
• Testing laboratories and conformity assessment bodies apply the test methods for certification and compliance.
• Dental clinics and procurement teams reference the standard when specifying equipment to ensure durability, sterilizability and patient safety.
• Regulators and notified bodies use it as a benchmark for medical device conformity in Europe.

Related standards and notes

• Prepared by ISO/TC 106 (Dentistry) and CEN/TC 55; endorsed as EN ISO 14457:2017.
• Supersedes EN ISO 14457:2012.
• Consult other ISO/CEN dental device standards and guidance for complementary requirements (e.g., sterilization standards, biocompatibility and EMC standards).