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 1639:2009 |
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Title | Dentistry - Medical devices for dentistry - Instruments |
Work Item Number | 00055279 |
Abstract/Scope | This European Standard specifies general requirements for instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by EN 1640. Tests for demonstrating compliance with this European 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 | 11.060.25 - Dental instruments |
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 1639:2004 |
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Superseded by | prEN 1639 rev |
Normative reference (6) |
EN 13060+A1
EN 1640 EN 21942-1:1991
EN 21942-3:1993
EN 23964:1989
EN 29168:1994
EN 556-1
EN 60601-1 EN ISO 10323 EN ISO 11135-1 EN ISO 11137-1 EN ISO 11607-1 EN ISO 11607-2 EN ISO 13295 EN ISO 13397-1 EN ISO 13397-2 EN ISO 13397-3 EN ISO 13397-4 EN ISO 13402 EN ISO 14155-1 EN ISO 14155-2 EN ISO 15087-1 EN ISO 15087-2 EN ISO 15087-3 EN ISO 15087-4 EN ISO 15087-5 EN ISO 15087-6 EN ISO 15098-1 EN ISO 15098-2 EN ISO 15098-3 EN ISO 15883-1 EN ISO 17664 EN ISO 17665-1 EN ISO 1797-1 EN ISO 1797-2 EN ISO 21531 EN ISO 21533 EN ISO 2157 EN ISO 21671 EN ISO 3630-1 EN ISO 3630-2 EN ISO 3630-3 EN ISO 3823-1 EN ISO 3823-2 EN ISO 7153-1 EN ISO 7492 EN ISO 7711-1 EN ISO 7711-2 EN ISO 7711-3 EN ISO 7785-1 EN ISO 7785-2 EN ISO 7885 EN ISO 8325 EN ISO 9173-1 EN ISO 9687 EN ISO 9873 EN ISO 9997 ISO 8601 |
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.