DIN EN ISO 18397:2016-09
Current
The latest, up-to-date edition.
DENTISTRY - POWERED SCALER (ISO 18397:2016)
Hardcopy , PDF
German, English
01-01-2016
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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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