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EN ISO 14457:2017

EN ISO 14457:2017

Current

Current

The latest, up-to-date edition.

Dentistry - Handpieces and motors (ISO 14457:2017)

Published date

12-06-2017

Publisher

Comite Europeen de Normalisation

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European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification of handpieces
5 Requirements and performance
6 Sampling
7 Testing
8 Instructions for use, maintenance and service
9 Technical description
10 Marking
11 Labelling
12 Packaging
Annex A (informative) - Handpiece and motor category tree
Annex B (informative) - Test report form
Bibliography

ISO 14457:2017 specifies requirements and test methods for handpieces and motors used in dentistry for treatment of patients and having patient contact, regardless of their construction. It also specifies requirements for manufacturer's information, marking and packaging.ISO 14457:2017 is applicable to the following:a) straight and angle handpieces;b) high-speed air turbine handpieces;c) air motors;d) electrical motors;e) prophy handpieces.ISO 14457:2017 is not applicable to the following:- intraoral camera handpieces;- powered polymerization handpieces;- air-powered scalers;- electrical-powered scalers;- powder jet handpieces;- multifunction handpieces (syringes).NOTE See Annex A for clarification of handpieces and motor types covered by ISO 14457:2017.

Committee
CEN/TC 55
DevelopmentNote
Supersedes EN ISO 11498, EN ISO 13294, EN ISO 7785-1 & EN ISO 7785-2. (11/2012)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

ISO 21531:2009 Dentistry Graphical symbols for dental instruments
ISO 6507-1:2005 Metallic materials Vickers hardness test Part 1: Test method
ISO 9168:2009 Dentistry Hose connectors for air driven dental handpieces
ISO 5349-2:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 2: Practical guidance for measurement at the workplace
IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 13295:2007 Dentistry — Mandrels for rotary instruments
ISO 1797:2017 Dentistry — Shanks for rotary and oscillating instruments
ISO 3964:2016 Dentistry — Coupling dimensions for handpiece connectors
ISO 1942:2009 Dentistry Vocabulary
ISO 2768-2:1989 GENERAL TOLERANCES - PART 2: GEOMETRICAL TOLERANCES FOR FEATURES WITHOUT INDIVIDUAL TOLERANCE INDICATIONS
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9687:2015 Dentistry — Graphical symbols for dental equipment
ISO 5349-1:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements
ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

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