CENELEC
CLC/TC 62 |
Electrical equipment in medical practice |

Project
| Reference | EN 62083:2009 |
|---|---|
| Title | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| Project Number | 21813 |
| Abstract/Scope | IEC 62083:2009 applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems: - for use in radiotherapy treatment planning in human medical practice; - that imports data either through input by the operator or directly from other devices; - that outputs data either in printed form for review or directly to other devices; and which is intended to be: a) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training; b) maintained in accordance with the recommendations given in the instructions for use, and c) used within the environmental and electrical supply conditions specified in the technical description. This second edition replaces the first edition of IEC 62083, published in 2000. This edition constitutes a technical revision, which brings this standard in line with changes to the other standards referred to in this standard. |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2009-12-11 |
| Current Stage code deadline | 2010-08-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62C |
|---|---|
| Reference Document | IEC 62083:2009 (EQV) |
| ICS | 11.040.60 - Therapy equipment |
| Keywords | Medical; Safety; Radiotherapy; Planning system |
| Note | Supersedes EN 62083:2001 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2009-11-01 |
|---|---|
| date of Availability (DAV) (2) | 2009-12-11 |
| date of Announcement (DOA) (3) | 2010-02-01 |
| date of Publication (DOP) (4) | 2010-08-01 |
| date of Withdrawal (DOW) (5) | 2012-11-01 |
Relations
| Supersedes | EN 62083:2001 |
|---|---|
| Superseded by | |
| Normative reference (6) | ICRU Report 42:1987 EN 60601-1 EN 60601-1-2:2007 corr. March 2010 IEC 60601-2-1:2009 EN 60601-2-11 IEC/TR 60788 EN 60950-1:2006 corr. A12:2011 FprAE:2013 A11:2009 EN 61000-4-1:2007 EN 61000-4-2:2009 EN 61000-4-3:2006 EN 61000-4-4:2004 EN 61217:1996 EN 62304:2006 corr. November 2008 EN 62366 |
(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.
