ISO 18397:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Dentistry — Powered scaler
Hardcopy , PDF
English, French
15-01-2016
02-11-2025
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 |
ISO/TC 106/SC 4
|
| DevelopmentNote |
Supersedes ISO/DIS 18397, ISO 15606 and ISO 22374. (01/2016)
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN ISO 18397 : 2016 | Identical |
| I.S. EN ISO 18397:2016 | Identical |
| ÖNORM EN ISO 18397: 2016 09 01 | Identical |
| DIN EN ISO 18397:2016-09 | Identical |
| NBN EN ISO 18397 : 2016 | Identical |
| NS EN ISO 18397 : 2016 | Identical |
| EN ISO 18397:2016 | Identical |
| PN EN ISO 18397 : 2016 | Identical |
| NF EN ISO 18397 : 2016 | Identical |
| BS EN ISO 18397:2016 | Identical |
| SS-EN ISO 18397:2016 | Identical |
| DS EN ISO 18397 : 2016 | Identical |
| UNE-EN ISO 18397:2016 | Identical |
| ISO 19213:2017 | Implants for surgery — Test methods of material for use as a cortical bone model |
| BS ISO 19213:2017 | Implants for surgery. Test methods of material for use as a cortical bone model |
| 16/30310674 DC : 0 | BS EN ISO 14457 - DENTISTRY - HANDPIECES AND MOTORS |
| ISO 14457:2017 | Dentistry — Handpieces and motors |
| 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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