- Standard No.
- EN ISO 18397:2016
- Release Date
- 2016
- Published By
- European Committee for Standardization (CEN)
- Latest
-
EN ISO 18397:2016
- Replace
-
FprEN ISO 18397:2015
- Scope
- This International Standard specifies requirements and test methods for air-powered and electrically powered scaler handpieces and scaler tips, including ultrasonic scalers of the piezoelectric, ferrostrictive and magnetostrictive types, operated as stand-alone parts or in conjunction with dental treatment units and for patient use. It also contains specifications for instructions for use, labeling and packaging.
EN ISO 18397:2016 Referenced Document
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
- IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment
- ISO 1942:2009 Dentistry - Vocabulary
- ISO 5349-1:2001 Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 1: General requirements
- ISO 5349-2:2001 Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 2: Practical guidance for measurement in the workplace
- ISO 7494-1:2011 Dentistry - Dental units - Part 1: General requirements and test methods
- ISO 9168:2009 Dentistry - Hose connectors for air driven dental handpieces
- ISO 9687:2015 Dentistry - Graphical symbols for dental equipment
EN ISO 18397:2016 history
EN ISO 18397:2016 Dentistry - Powered scaler (ISO 18397:2016) has been changed from EN ISO 15606:1999 Dental Handpieces - Air-Powered Scalers and Scaler Tips ISO 15606: 1999.
EN ISO 18397:2016 Dentistry - Powered scaler (ISO 18397:2016) has been changed from EN ISO 22374:2005 Dentistry - Dental handpieces - Electrical-powered scalers and scaler tips.