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IEC 60976-ed.2.0
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
STANDARD published on 16.10.2007
The information about the standard:
Designation standards: IEC 60976-ed.2.0
Publication date standards: 16.10.2007
SKU: NS-412055
The number of pages: 199
Approximate weight : 628 g (1.38 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60976-ed.2.0 :
Applies to medical electron accelerators when used, for therapy purposes, in human medical practice. This standard applies to medical electron accelerators which 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 source 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 purchasers 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. This standard 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 which 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 given in Annex A. 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. This second edition cancels and replaces the first edition published in 1989. It constitutes a technical revision. This second edition includes the addition of performance standards and test methods relating to the following new technologies: - dynamic beam delivery techniques, such as moving beam radiotherapy, intensity-modulated radiation therapy (IMRT), image-guided radiotherapy (IGRT) and programmable wedge fields; - stereotactic radiotherapy (SRT) / stereotactic radiosurgery (SRS); - use of electronic imaging devices. This standard, together with IEC TR 60977, should be read in conjunction with IEC 60601-2-1. Sapplique aux accelerateurs medicaux delectrons utilises a des fins therapeutiques, en medecine humaine. Cette norme sapplique aux accelerateurs medicaux delectrons delivrant un faisceau de rayonnement soit rayonnement X soit rayonnement electronique avec des energies nominales comprises dans lintervalle de 1 MeV a 50 MeV avec un debit de dose absorbee maximum de 0,001 Gy s-1 a 1 Gy s-1 a 1 m de la source de rayonnement et a une distance normale de traitement entre 50 cm et 200 cm de la source de rayonnement. La presente norme decrit des mesures et des methodes dessai a realiser par le fabricant au moment de la conception et de la construction dun accelerateur medical delectrons mais elle ne specifie pas les essais de reception devant etre effectues apres linstallation sur le site de lacheteur. Cependant, le rapport daccompagnement CEI 60977 suggere que de nombreuses methodes dessai sont applicables aux essais de reception. Les conditions de mesure decrites dans la presente norme ne sont pas identiques a celles precedemment en usage. Cela sapplique en particulier a la position du fantome pour les mesures et a la mesure des distances a partir de lisocentre. Il convient que ces nouvelles conditions remplacent les precedentes et ne sy ajoutent pas. Cette norme specifie les methodes dessai pour la determination et la declaration des caracteristiques fonctionnelles dont la connaissance est necessaire pour une application et une utilisation correctes dun accelerateur medical delectrons. Elles doivent etre declarees dans les documents daccompagnement ainsi que les ecarts ou variations maximum auxquels on peut sattendre dans les conditions definies dutilisation normale. Un modele pour la presentation des valeurs des caracteristiques fonctionnelles est donne a lAnnexe A. Il est necessaire de tenir compte de limprecision des methodes de mesure dans la determination des caracteristiques. Cependant, il na pas semble souhaitable dinclure les erreurs dans une tolerance globale, mais de les separer, esperant que des methodes de mesure plus precises soient mises au point. Il nest pas dans le but de cette norme dempecher, de quelque facon que ce soit le developpement futur dequipements de conception nouvelle qui pourraient avoir des modes de fonctionnement et des parametres differents de ceux decrits ci-apres, a condition que de tels equipements conduisent a des caracteristiques fonctionnelles de niveau equivalent pour le traitement des patients. Sauf indication contraire, la presente norme sapplique aux accelerateurs medicaux delectrons avec support isocentrique. Si lequipement est non isocentrique, la description des caracteristiques et les methodes dessai peuvent necessiter detre convenablement adaptees. Cette deuxieme edition annule et remplace la premiere edition publiee en 1989 dont elle constitue une revision technique. Cette deu
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