CENELEC
CLC/TC 62 |
Electrical equipment in medical practice |
Project
| Reference | EN 62083:2001 |
|---|---|
| Title | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| Project Number | 7619 |
| Abstract/Scope | Applies to the design, manufacture and some installation aspects of an RTPS - for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; - that imports data either through input by the OPERATOR or direct from other devices; - that outputs data either in printed form for review or direct to other devices; - and which is intended to be . for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; . maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and . used within the environmental and electrical supply conditions SPECIFIED in the technical descriptions. An RTPS is principally a software application, and the object of this standard is to establish the requirements for features, associated documentation, and testing of the software. |
| Status |
Withdrawn
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2001-02-12 |
| Current Stage code deadline | 2001-09-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/023; M/432 |
| Order Voucher | BC/CLC/93-01 |
Details
| IEC Technical Body | IEC/SC 62C |
|---|---|
| Reference Document | IEC 62083:2000 (EQV) |
| ICS | 11.040.60 - Therapy equipment |
| Keywords | Medical; Radiotherapy; Treatment; Planning; Safety |
| Note | EN following parallel voten * Superseded by EN 62083:2009 |
| 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) | 2000-12-01 |
|---|---|
| date of Availability (DAV) (2) | 2001-02-12 |
| date of Announcement (DOA) (3) | 2001-03-01 |
| date of Publication (DOP) (4) | 2001-09-01 |
| date of Withdrawal (DOW) (5) | 2003-12-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | EN 62083:2009 |
| Normative reference (6) | ICRU Report 42:1987 EN 60601-1:1990 corr. July 1994 A11:1993 A12:1993 A13:1996 EN 60601-1-2:1993 corr. December 1997 EN 60601-1-4:1996 HD 501 S1:1988 EN 60950:2000 corr. February 2002 EN 61000-4-1:2000 EN 61000-4-2:1995 EN 61000-4-3:1996 EN 61000-4-4:1995 EN 61217:1996 |
(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.
