BS EN 60976:2007 - Medical electrical equipment. Medical electron accelerators. Functional performance characteristics – BSI British Standards

BS EN 60976:2007

Medical electrical equipment. Medical electron accelerators. Functional performance characteristics

Status : Current   Published : April 2008

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This second edition of BS EN 60976 includes the addition of performance standards and test methods relating to several relatively new technologies introduced within the last few years, including dynamic beam delivery techniques, such as moving beam radiotherapy, intensity-modulated radiation therapy (MRT), image-guided radiotherapy (IGRT), and programmable wedge fields (PWF). Also included are stereotactic radiotherapy (SRT)/ Stereotactic radiosurgery (SRS) and the use of certain electromagnetic imaging devices. In recognition of the diversity of equipment produced by manufacturers in each of these technologies, this second edition has specified performance standards, methods of test, and methods of disclosure of functional performance, that are as basic and generic as possible.

Manufacturers may add more detailed information and special tests of performance
characteristics to each performance category, in their accompanying documents.

BS EN 60976:2007 is the international standard that applies to medical electron accelerators when used for therapy purposes, in human medical practice.

This standard applies to medical electron accelerators that deliver a radiation beam of
either X-radiation or electron radiation with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s–1 and 1 Gy s–1 at 1 m from the radiation souurce and at normal treatment distances between 50 cm and 200 cm from the radiation source.

The present standard describes measurements and test procedures to be performed by the manufacturer at the design and construction stage of a medical electron accelerator  but does not specify acceptance tests to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for acceptance tests.

The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the phantom position for measurements and the measurement of distances from the isocentre. These new conditions should be substituted for and not be added to previous methods.

BS EN 60976 specifies test procedures for the determination and disclosure of functional
performance characteristics, knowledge of which is deemed necessary for proper application and use of a medical electron accelerator and that are to be declared in the accompanying documents together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of functional performance values is provided.

It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it was not felt to be advisable to combine the errors into an overall performance tolerance but to keep them separate in the expectation that more accurate test methods will be evolved.

It is not intended that this standard should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the treatment of patients.

Except where otherwise stated this standard assumes that the medical electron accelerators  have an isocentric gantry. Where the equipment is non-isocentric, the description of performance and test methods may need to be suitably adapted.

A statement of compliance with this standard does not necessarily imply that these tests will be or have been applied as type tests or as individual tests.

BS EN 60976:2007 replaces BS EN 60976:2001, which has been withdrawn.




Standard NumberBS EN 60976:2007
TitleMedical electrical equipment. Medical electron accelerators. Functional performance characteristics
StatusCurrent
Publication Date30 April 2008
Normative References(Required to achieve compliance to this standard)IEC 60601-2-1:1998/AMD 1:2002, EN 61217:1996, EN 60601-1:2006, IEC/TR 60788:2004, EN 60601-2-1:1998/AMD 1:2002, IEC 60601-1:2005, EN 60601-2-1:1998, EN 60580:2000, IEC 60977, IEC 61217, IEC 60580:2000, IEC 61223-1:1993, IEC 60601-2-1:1998
Informative References(Provided for Information)No other standards are informatively referenced
ReplacesBS EN 60976:2001, BS 5724-3.1:1990 IEC 60976:198
International RelationshipsEN 60976:2007,IEC 60976:2007
DescriptorsRadiology apparatus (medical), Electron accelerators, Testing conditions, Performance, Reproducibility, X-ray apparatus, Environment (working), Handbooks, Radiation measurement, Performance testing, Image processing (computer), Medical radiology, Stability, Radiotherapy, Electron beams, Medical equipment, Electrical medical equipment, Particle accelerators, Type testing, Calibration
ICS11.040.50
13.280
Title in FrenchAppareils électromédicaux. Accélérateurs médicaux d'électrons. Caractéristiques fonctionnelles de performance
Title in GermanMedizinische elektrische Geräte. Medizinische Elektronenbeschleuniger. Apparative Qualitätsmerkmale
CommitteeCH/62/3
ISBN978 0 580 55685 2
PublisherBSI
FormatA4
DeliveryYes
Pages102
File Size1.181 MB
Price£292.00


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