ISO 18397:2016
Withdrawn
View Superseded by
Dentistry — Powered scaler
Hardcopy , PDF
English, French
01-15-2016
11-02-2025
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Withdrawn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 |
| 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 |
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| 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 |
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| 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 |
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| 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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