EN ISO 20608:2018
Current
The latest, up-to-date edition.
Dentistry - Powder jet handpieces and powders (ISO 20608:2018)
16-05-2018
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification of handpieces
5 Requirements
6 Sampling
7 Measurement and test methods
8 Instructions for use, maintenance and service
9 Technical description
10 Marking and labelling
11 Packaging
Annex A (informative) - Example of a test report
ISO 20608:2018 specifies the general requirements, test methods, manufacturer's information, marking and packaging, independently of the design of the powder jet handpieces (see Figure 1).ISO 20608:2018 applies to powder jet handpieces and their associated powders for use in the field of dentistry. They are used on patients to remove dental debris, discolourations and plaque and to clean and polish teeth where abrasion is a side effect.ISO 20608:2018 is also applicable to powder jet handpieces and their associated powders that are used in dentistry for air driven abrasion, e.g. minimally invasive cavity preparation, preparation of surfaces for adhesives and for the removal of cement residues where abrasion is part of the desired outcome.ISO 20608:2018 is not applicable for the dental units that are employed to supply the powder jet handpieces.ISO 20608:2018 is not applicable to dental prophylaxis handpieces (contra angles), or electrically driven plaque removers (scalers) or multifunctional handpieces (syringes).
Committee |
CEN/TC 55
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Standards | Relationship |
PN-EN ISO 20608 : 2018-08 | Identical |
ÖNORM EN ISO 20608: 2018 10 01 | Identical |
SN EN ISO 20608:2018 | Identical |
BS EN ISO 20608:2018 | Identical |
DIN EN ISO 20608:2018-08 | Identical |
NF EN ISO 20608:2018 | Identical |
UNI EN ISO 20608:2018 | Identical |
ISO 20608:2018 | Identical |
I.S. EN ISO 20608:2018 | Identical |
SS-EN ISO 20608 : 2018 | Identical |
NEN-EN-ISO 20608:2018 en | Identical |
NS EN ISO 20608:2018 | Identical |
UNE-EN ISO 20608:2018 | 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 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 11014:2009 | Safety data sheet for chemical products Content and order of sections |
ISO 5349-1:2001 | Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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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