CENELEC
Project
| Reference | EN 60601-2-63:201X |
|---|---|
| Title | Medical electrical equipment - Part 2-63: Particular requirements for basic safety and essential performance of dental extra-oral x-ray equipment |
| Project Number | 23427 |
| Abstract/Scope | IEC 60601-2-63:2012 applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental extra-oral x-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. The scope of this standard is restricted to X-ray equipment where: - the x-ray tube assembly contains the high-voltage transformer assembly; and - the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during intended use. |
| Status |
Approved
|
Status
| Current Stage code | 5099 |
|---|---|
| Current Stage code date | 2012-10-24 |
| Current Stage code deadline | 2012-11-21 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62B |
|---|---|
| Reference Document | IEC 60601-2-63:2012 (EQV) |
| ICS | 11.040.50 - Radiographic equipment |
| Keywords | Medical; Equipment; Dental; Extra-oral; X-ray |
| Note | 2012-10-09: Publication editing allocated to hamrani@cencenelec.eu |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
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Clause
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Categories - Aspects
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Product Life Cycle
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Information
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History
Implementation Dates
| date of Ratification (DOR) (1) | 2012-10-24 |
|---|---|
| date of Availability (DAV) (2) | |
| date of Announcement (DOA) (3) | 2013-01-24 |
| date of Publication (DOP) (4) | 2013-07-24 |
| date of Withdrawal (DOW) (5) | 2015-10-24 |
Relations
| Supersedes | |
|---|---|
| Superseded by | |
| Normative reference (6) |
EN 60336:2005
EN 60601-1-2:2007 corr. March 2010 EN 60601-1-3:2008 corr. March 2010 EN 60601-2-29:2008 A11:2011 EN 60601-2-54:2009 IEC/TR 60788:2004 IEC/PAS 61910-1:2007 |
(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.
