CENELEC
CLC/TC 62 |
Electrical equipment in medical practice |
Project
| Reference | EN 60601-2-54:2009 |
|---|---|
| Title | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| Project Number | 21882 |
| Abstract/Scope | IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54. |
| Status |
Withdrawn
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2009-09-18 |
| Current Stage code deadline | 2010-05-01 |
| 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 60601-2-54:2009 (EQV) |
| ICS | 11.040.50 - Radiographic equipment |
| Keywords | Medical,X-ray;Radiography;Radioscopy;Safety |
| Note | Supersedes EN 60601-2-7:1998, EN 60601-2-32:1994 and (partially) EN 60601-2-28:1993 * Partially superseded by EN 60601-2-43:2010 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2009-08-01 |
|---|---|
| date of Availability (DAV) (2) | 2009-09-18 |
| date of Announcement (DOA) (3) | 2009-11-01 |
| date of Publication (DOP) (4) | 2010-05-01 |
| date of Withdrawal (DOW) (5) | 2012-08-01 |
Relations
| Supersedes | EN 60601-2-7:1998 EN 60601-2-28:1993 EN 60601-2-32:1994 |
|---|---|
| Superseded by | EN 60601-2-43:2010 |
| Normative reference (6) |
EN 60336:2005
EN 60580:2000 EN 60601-1-2:2007 corr. March 2010 EN 60601-1-3:2008 corr. March 2010 IEC/TR 60788:2004 EN 60806:2004 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.
