BS EN ISO 18397:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Dentistry. Powered scaler
Hardcopy , PDF
English
31-03-2016
09-07-2025
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.
| Committee |
CH/106
|
| DevelopmentNote |
Supersedes BS EN ISO 15606, BS EN ISO 22374 & 14/30273278 DC. (04/2016)
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| Standards | Relationship |
| EN ISO 18397:2016 | Identical |
| ISO 18397:2016 | Identical |
| DIN EN ISO 18397:2016-09 | Equivalent |
| 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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