CENELEC
Project
| Reference | EN 60601-2-29:1995 |
|---|---|
| Title | Medical electrical equipment - Part 2: Particular requirements for the safety of radiotherapy simulators |
| Project Number | 4920 |
| Abstract/Scope | This clause of the General Standard applies, except as follows: 1.1 Scope Addition: This Standard applies to RADIOTHERAPY SIMULATORS which use diagnostic X-RAY EQUIPMENT to simulate physically a therapeutic RADIATION BEAM. So that the TREATMENT VOLUME to be irradiated during RADIOTHERAPY can be localized, and the position and size of the therapeutic RADIATION FIELD can be confirmed. This Standard applies to RADIOTHERAPY SIMULATORS using HIGH-VOLTAGE GENERATORS complying with EN 60601-2-7. This Standard applies to RADIOTHERAPY SIMULATORS intended exclusively for RADIOTHERAPY simulation as a prelude to intended RADIOTHERAPY, and not for any other purpose such as general diagnostic examinations. This Standard applies to RADIOTHERAPY SIMULATORS comprising the following parts: a} A system for producing a RADIATION BEAM not exceeding 400 kV which simulates the geometry of the RADIOTHERAPY RADIATION BEAM. b) A system for producing images of the transmitted X-RAY BEAM, for example either by RADIOGRAPHY or by RADIOSCOPY. C) An assembly to control the size of the RADIATION BEAM and to DELINEATE the intended treatment area. d) A mechanical structure which physically simulates the geometry and motions of the RADIOTHERAPY EQUIPMENT and supports the imaging system. e) A PATIENT SUPPORT system. |
| Status |
Withdrawn
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 1995-11-30 |
| Current Stage code deadline | 1996-07-01 |
| Deadline date for vote |
Legal
| Directive(s) | |
|---|---|
| Mandate(s) | M/023 |
| Order Voucher | BC/CLC/93-01 |
Details
| IEC Technical Body | IEC/SC 62C |
|---|---|
| Reference Document | IEC 60601-2-29:1993 (EQV) |
| ICS | 11.040.60 - Therapy equipment |
| Keywords | Medical equipment; Radiotherapy; Simulator; Safety |
| Note | Superseded by EN 60601-2-29:1999 |
| 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) | 1995-05-15 |
|---|---|
| date of Availability (DAV) (2) | 1995-11-30 |
| date of Announcement (DOA) (3) | 1996-01-01 |
| date of Publication (DOP) (4) | 1996-07-01 |
| date of Withdrawal (DOW) (5) | 1996-07-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | EN 60601-2-29:1999 |
| Normative reference (6) |
EN 60601-1-3:1994
IEC 60601-2-1:1981 HD 395.2.7 S1:1989 HD 501 S1:1988 |
(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.
