EN 1640:2004

Dentistry - Medical devices for dentistry - Equipment EN 1640:2004

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Oct 28, 2009

CEN

CEN/TC 55 Dentistry

European Norm

11.060.20   Dental equipment

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Scope

This European Standard specifies general requirements for items of dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.
This European Standard does not include requirements for dental X-ray equipment.
This European Standard does not apply to any dental instruments connected to an item of dental equipment. These instruments are covered by the level 2 and level 3 standards for dental instruments.
Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 1640:1996

NOW

WITHDRAWN
EN 1640:2004
99.60 Withdrawal effective
Oct 28, 2009

REVISED BY

PUBLISHED
EN 1640:2009