Publication details
| Publication CODE |
Title |
| NBN EN 60601-2-1:2015 (2015-10) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS in THE RANGE 1 MEV TO 50 MEV |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
4 P.. |
Description
Applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients.
This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy; it does not attempt to define their optimum performance requirements.
Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment.
It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment.
This edition cancels and replaces the previous edition.
It constitutes a technical revision.
This edition addresses the following issues not covered in previous editions:
- alignment with the new relevant collateral standards;
- new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).
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| Class |
C
|
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
Very important notice: 98% of the text of the NBN EN 55XXX,
NBN EN 6XXXX comes from the IEC text which is NOT included.
This text can be ordered here:
IEC 60601-2-1:2009.
For the series NBN EN 50XXX, the standards are however complete.
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DE version
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EN version
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FR version
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Status
Origin
| Committee |
TC 62
ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2015-09-15 |
| NBN Approval |
2015-11-30 |
| Belgian Official Journal |
2016-02-02 |
| Registration |
159738 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.60
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2015-09-15 |
| Date of availability (d.a.v.) |
2015-10-23 |
| Date of announcement (d.o.a.) |
2015-12-15 |
| Date of publication (d.o.p.) |
2016-06-15 |
| Date of withdrawal former edition (d.o.w.) |
2018-09-15 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 60601-2-1:2015
|
2015-10-23 |
| is identical to |
IEC 60601-2-1:2009/ed. 3.0
|
2009-10-13 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Foreign |
IEC/TR 60788:2004 |
|
| Standard |
Belgium |
NBN EN 61217:1996 |
|
|
