Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search

DIN EN ISO 18397 E : 2016

Current
Current

The latest, up-to-date edition.

DENTISTRY - POWERED SCALER (ISO 18397:2016)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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 E & DIN EN ISO 22374 E. (09/2016)
DocumentType
Standard
Pages
27
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
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 9687 E : 2015 DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
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 21531 E : 2009 DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
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)
ISO 1942:2009 Dentistry Vocabulary
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
DIN EN ISO 9168 E : 2009 DENTISTRY - HOSE CONNECTORS FOR AIR DRIVEN DENTAL HANDPIECES
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
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

View more information
US$106.75
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us