CENELEC
CLC/TC 62 |
Electrical equipment in medical practice |
Project
| Reference | EN 60601-2-65:2013 |
|---|---|
| Title | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
| Project Number | 23428 |
| Abstract/Scope | IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. 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 intra-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 intra-oral X-ray equipment. Components and their functions are addressed as far as necessary. |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2013-01-11 |
| Current Stage code deadline | 2013-07-24 |
| Deadline date for vote |
Legal
| Directive(s) | MDD pending (93/42/EEC) |
|---|---|
| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62B |
|---|---|
| Reference Document | IEC 60601-2-65:2012 (EQV) |
| ICS | 11.040.50 - Radiographic equipment |
| Keywords | Medical; Equipment; Dental; Intra-oral; X-ray |
| Note | Supersedes EN 60601-2-7:1998 (PART), EN 60601-2-32:1994 (PART) * to be read in conjunction with EN 60601-1:2006 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2012-10-24 |
|---|---|
| date of Availability (DAV) (2) | 2013-01-11 |
| 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 | EN 60601-2-7:1998 EN 60601-2-32:1994 |
|---|---|
| Superseded by | |
| Normative reference (6) |
EN 60336:2005
EN 60601-1-2:2007 corr. March 2010 EN 60601-1-3:2008 corr. March 2010 IEC/TR 60788:2004 EN 62220-1:2004 |
(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.
