NBN EN 1640 : 2009
Current
The latest, up-to-date edition.
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Chemical and physical properties
4.2.1 Materials
4.2.2 Contaminants and residues
4.2.3 Contact with substances
4.2.4 Ingress and leaking of substances
4.3 Control of contamination
4.4 Construction and environmental properties
4.5 Protection against radiation
4.6 Equipment connected to or equipped with an energy
source
4.7 Protection against electrical risks
4.8 Protection against mechanical and thermal risks
4.8.1 Mechanical stability
4.8.2 Vibration
4.8.3 Noise
4.8.4 Electricity, gas, hydraulic and pneumatic
energy
4.8.5 Surface temperature
4.9 Controls and indicators
4.10 Marking, labelling and information supplied by the
manufacturer
4.10.1 General
4.10.2 Symbols
4.10.3 Marking
4.10.4 Labelling
4.10.5 Detachable components
4.10.6 Instructions for use
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC
Bibliography
Describes general requirements for items of dental equipment used in the practice of dentistry and which are medical devices.
DocumentType |
Standard
|
PublisherName |
Belgian Standards
|
Status |
Current
|
Standards | Relationship |
UNI EN 1640 : 2010 | Identical |
BS EN 1640:2009 | Identical |
EN 1640:2009 | Identical |
DIN EN 1640:2010-02 | Identical |
I.S. EN 1640:2009 | Identical |
UNE-EN 1640:2010 | Identical |
SN EN 1640 : 2010 | Identical |
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