Publication details
| Publication CODE |
Title |
| NBN EN 60601-2-11:2015 (2015-05) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-11: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF GAMMA BEAM THERAPY EQUIPMENT |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
4 P.. |
Description
Applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment.
This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition.
Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It does not attempt to define the optimum performance requirements for a gamma beam therapy equipment for use in radiotherapy. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an interlock then operates to prevent continued operation.
This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.
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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 60601-2-11:2013.
For the series NBN EN 50XXX, the standards are however complete.
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EN version
|
DE version
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FR version
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Status
Origin
| Committee |
TC 62/SC 62C
EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2015-04-14 |
| NBN Approval |
2015-07-24 |
| Belgian Official Journal |
2015-08-13 |
| Registration |
158288 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.50
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2015-04-14 |
| Date of availability (d.a.v.) |
2015-05-22 |
| Date of announcement (d.o.a.) |
2015-07-14 |
| Date of publication (d.o.p.) |
2016-01-14 |
| Date of withdrawal former edition (d.o.w.) |
2018-04-14 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 60601-2-11:2015
|
2015-05-22 |
| is identical to |
IEC 60601-2-11:2013/ed. 3.0
|
2013-01-16 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Document |
Foreign |
IEC/TR 60788:2004 |
|
| Standard |
Belgium |
NBN EN 60601-1-3:2008 |
|
| Standard |
Belgium |
NBN EN 61217 |
|
|
