CENELEC
Project
| Reference | EN 60601-2-45:2011 |
|---|---|
| Title | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
| Project Number | 22703 |
| Abstract/Scope | IEC 60601-2-45:2011 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2011-03-18 |
| Current Stage code deadline | |
| Deadline date for vote |
Legal
| Directive(s) | MDD pending (93/42/EEC) |
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| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62B |
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| Reference Document | IEC 60601-2-45:2011 (EQV) |
| ICS | 11.040.50 - Radiographic equipment |
| Keywords | Medical; Safety; Mammography; X-ray; Stereotactic |
| Note | Supersedes EN 60601-2-45:2001 |
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| 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) | 2011-03-17 |
|---|---|
| date of Availability (DAV) (2) | 2011-03-18 |
| date of Announcement (DOA) (3) | 2011-06-17 |
| date of Publication (DOP) (4) | 2011-12-17 |
| date of Withdrawal (DOW) (5) | 2014-03-17 |
Relations
| Supersedes | EN 60601-2-45:2001 |
|---|---|
| Superseded by | |
| Normative reference (6) | ISO 9236-3:1999 EN 60336:2005 EN 60601-1-2:2007 corr. March 2010 EN 60601-1-3:2008 corr. March 2010 EN 60613:2010 IEC/TR 60788:2004 EN 61223-3-2:2008 EN 62220-1-2:2007 |
(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.
