EN ISO 18397:2016
Current
The latest, up-to-date edition.
Dentistry - Powered scaler (ISO 18397:2016)
24-02-2016
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
ISO 18397:2016 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 |
CEN/TC 55
|
| DevelopmentNote |
Supersedes EN ISO 22374 and EN ISO 15606. (03/2016)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 18397:2016-09 | Identical |
| PN EN ISO 18397 : 2016 | Identical |
| NF EN ISO 18397 : 2016 | Identical |
| ISO 18397:2016 | Identical |
| BS EN ISO 18397:2016 | Identical |
| SS-EN ISO 18397:2016 | Identical |
| SN EN ISO 18397 : 2016 | Identical |
| UNI EN ISO 18397 : 2016 | Identical |
| ÖNORM EN ISO 18397: 2016 09 01 | Identical |
| NBN EN ISO 18397 : 2016 | Identical |
| NS EN ISO 18397 : 2016 | Identical |
| NEN EN ISO 18397 : 2016 | Identical |
| UNE-EN ISO 18397:2016 | Identical |
| I.S. 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 |
| 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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