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BS EN ISO 18397:2016

Current
Current

The latest, up-to-date edition.

Dentistry. Powered scaler
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-31-2016

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

Defines requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients.

This International Standard specifies requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers’ instructions, marking and packaging.

Committee
CH/106/4
DevelopmentNote
Supersedes BS EN ISO 15606, BS EN ISO 22374 & 14/30273278 DC. (04/2016)
DocumentType
Standard
Pages
28
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
EN ISO 18397:2016 Identical
ISO 18397:2016 Identical

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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 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 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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Hardcopy - English
PDF - English
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