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14/30273278 DC : 0

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

BS EN ISO 18397 - DENTISTRY - POWERED SCALER

Available format(s)

Hardcopy , PDF

Language(s)

English

Superseded date

31-03-2016

Superseded by

BS EN ISO 18397:2016

£20.00
Excluding VAT

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Superseded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

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

£20.00
Excluding VAT