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DIN
DIN EN ISO 18397 E : 2016

DIN EN ISO 18397 E : 2016

Current

Current

The latest, up-to-date edition.

DENTISTRY - POWERED SCALER (ISO 18397:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
European foreword
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. Also contains specifications on manufacturers' instructions, marking and packaging.

DevelopmentNote
Supersedes DIN EN ISO 15606 E & DIN EN ISO 22374 E. (09/2016)
DocumentType
Standard
Pages
27
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
Supersedes

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

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
DIN EN 61672-1:2014-07 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013)
DIN EN ISO 9687 E : 2015 DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
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
DIN EN ISO 21531 E : 2009 DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
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
DIN EN 62366-1 : 2017 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015 + COR1:2016)
ISO 1942:2009 Dentistry Vocabulary
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
DIN EN ISO 9168 E : 2009 DENTISTRY - HOSE CONNECTORS FOR AIR DRIVEN DENTAL HANDPIECES
ISO 9687:2015 Dentistry Graphical symbols for dental equipment
DIN EN 80601-2-60 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT (IEC 80601-2-60:2012)
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
DIN ISO 80601-2-60 : DRAFT 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT
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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