14/30273278 DC : 0

Superseded

View Superseded by

BS EN ISO 18397 - DENTISTRY - POWERED SCALER

Available format(s)

Hardcopy , PDF

Superseded date

03-31-2016

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification of scaler 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) - Calculation example for
power output
Bibliography

BS EN ISO 18397.

Committee	CH/106/4
DocumentType	Draft
Pages	28
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 18397:2016

ISO 21531:2009	Dentistry Graphical symbols for dental instruments
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 7405:2008	Dentistry Evaluation of biocompatibility of medical devices used in dentistry
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 14457:2017	Dentistry — Handpieces and motors
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
ISO 1942:2009	Dentistry Vocabulary
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 13402:1995	Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure
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
ISO 10650-2:2007	Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps
ISO 10650-1:2004	Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps