The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
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Reference | EN 1640:2009 |
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Title | Dentistry - Medical devices for dentistry - Equipment |
Work Item Number | 00055280 |
Abstract/Scope | This European Standard specifies general requirements for 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 apply to 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 EN 1639. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate. |
Status |
Published
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Reference Document | |
date of Availability (DAV) | 2009-10-28 |
ICS | 11.060.20 - Dental equipment |
A-Deviation(s) | |
Special National Condition(s) |
Directive(s) | 2007/47/EC, 93/42/EEC |
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Mandate(s) | M/023 |
Citation in OJEU | C 183 (2010-07-07) for Directive 93/42/EEC, Citation expected for Directive 2007/47/EC |
date of Ratification (DOR) (1) | 2009-09-19 |
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date of Availability (DAV) (2) | 2009-10-28 |
date of Announcement (DOA) (3) | 2010-01-31 |
date of Publication (DOP) (4) | 2010-04-30 |
date of Withdrawal (DOW) (5) | 2010-04-30 |
Supersedes | EN 1640:2004 |
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Superseded by | prEN 1640 rev |
Normative reference (6) |
EN 1639
EN 21942-1:1991
EN 21942-4:1993
EN 60601-1
EN 60601-1-4 EN 60825-1 EN 62304 EN ISO 10637 EN ISO 10650-1 EN ISO 10650-2 EN ISO 11143 EN ISO 11498 EN ISO 13294 EN ISO 14155-1 EN ISO 14155-2 EN ISO 17664 EN ISO 21530 EN ISO 6875 EN ISO 7488 EN ISO 7494-1 EN ISO 7494-2 EN ISO 9680 EN ISO 9687 ISO 2010 |
Sales Points |
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(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.