About CEN
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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Project
| Reference | EN ISO 23450:2021 |
|---|---|
| Title | Dentistry - Intraoral camera (ISO 23450:2021) |
| Work Item Number | 00055483 |
| Abstract/Scope | This document specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking. This document is not applicable to: a) powered polymerization activators for polymerization of dental materials; b) exclusively extraoral camera equipment to prepare overviews or to record treatments; c) dental microscopes for minimally invasive treatments; d) medical endoscopes; e) camera handpieces for tooth illumination (transillumination); f) CAD or CAM scanner handpieces; g) combinations of dental instruments with camera functions; h) cameras for endodontic purposes; i) devices for root canal inspection (endoscopic microcameras); j) cameras for tool navigation; k) cameras for determination of tooth colour. |
| Status |
Published
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| Reference Document |
ISO 23450:2021 (EQV)
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| date of Availability (DAV) | 2021-04-14 |
| ICS | 11.060.20 - Dental equipment |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | |
|---|---|
| Mandate(s) | |
| Citation in OJEU |
Implementation Dates
| date of Ratification (DOR) (1) | 2021-03-16 |
|---|---|
| date of Availability (DAV) (2) | 2021-04-14 |
| date of Announcement (DOA) (3) | 2021-07-31 |
| date of Publication (DOP) (4) | 2021-10-31 |
| date of Withdrawal (DOW) (5) | 2021-10-31 |
Relations
| Supersedes | |
|---|---|
| Superseded by | |
| Normative reference (6) |
IEC 60601-1
IEC 60601-1-6 IEC 62366-1 IEC 62471 IEC 80601-2-60 ISO 10993-1 ISO 15223-1 ISO 17664 ISO 1942 ISO 9687 |
| 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.