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DIN EN ISO 18397:2016-09

Current
Current

The latest, up-to-date edition.

DENTISTRY - POWERED SCALER (ISO 18397:2016)
Available format(s)

Hardcopy , PDF

Language(s)

German, English

Published date

01-01-2016

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 & DIN EN ISO 22374. (09/2016)
DocumentType
Standard
Pages
28
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
DIN EN ISO 15223-1:2015-08 (Draft) MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
DIN EN ISO 9687:2015-05 DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
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 21531:2009-08 DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
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 5349-2:2015-12 MECHANICAL VIBRATION - MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO HAND-TRANSMITTED VIBRATION - PART 2: PRACTICAL GUIDANCE FOR MEASUREMENT AT THE WORKPLACE (ISO 5349-2:2001 + AMD 1:2015)
DIN EN ISO 17664:2016-06 (Draft) PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
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)
DIN EN ISO 7494-1:2011-11 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011)
DIN EN ISO 5349-1:2001-12 MECHANICAL VIBRATIONS - MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO HAND-TRANSMITTED VIBRATION - PART 1: GENERAL REQUIREMENTS
ISO 1942:2009 Dentistry Vocabulary
DIN EN ISO 9168:2009-10 DENTISTRY - HOSE CONNECTORS FOR AIR DRIVEN DENTAL HANDPIECES
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
DIN EN ISO 14457:2016-05 (Draft) DENTISTRY - HANDPIECES AND MOTORS (ISO 14457:2017)
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
DIN EN ISO 1942:2011-03 Dentistry - Vocabulary (ISO 1942:2009, Corrected version 2010-03-01)
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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