Zertifizierung einer Translationsliege zur Ganzkörperbestrahlung aus In-Haus-Herstellung gemäß dem Medizinproduktegesetz

Scherf, Christian ; Härtl, Petra ; Treutwein, Marius ; Bogner, Ludwig

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Date of publication of this fulltext: 06 Feb 2012 13:00

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Details

Item type:	Article
Journal or Publication Title:	Zeitschrift für Medizinische Physik
Publisher:	Elsevier
Volume:	17
Number of Issue or Book Chapter:	2
Page Range:	pp. 144-152
Date:	19 June 2006
Additional Information (public):	Article in german
Institutions:	Medicine > Lehrstuhl für Strahlentherapie
Identification Number:	Value Type 10.1016/j.zemedi.2006.11.003 DOI 17665737 PubMed ID
Keywords:	Ganzkörperbestrahlung, In-Haus- Herstellung, Medizinproduktegesetz, funktionale Sicherheit, Total body irradiation, in-house manufacture, Medical Devices Act, functional safety
Dewey Decimal Classification:	600 Technology > 600 Technology (Applied sciences) 600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	23398

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Abstract

A new translational couch unit with extended potentials of dose optimization by variable velocity and a comfortable user interface with integrated patient administration was developed at the university clinic of Regensburg. MATERIALS AND METHODS: The concept and construction were elaborated in legal accordance with the in-house manufacture conditions mentioned in the German Medical Devices Act. ...

Abstract

A new translational couch unit with extended potentials of dose optimization by variable velocity and a comfortable user interface with integrated patient administration was developed at the university clinic of Regensburg. MATERIALS AND METHODS: The concept and construction were elaborated in legal accordance with the in-house manufacture conditions mentioned in the German Medical Devices Act. In particular we have implemented a concept of functional safety based on a controller unit, an independent monitoring unit and self-testing procedures. Redundant safety relevant hard- and software components are continuously checked against each other. In case of any malfunction the translation movement and the linear accelerator are stopped. Gap-free continuation of the treatment will be possible after elimination of the cause of the interrupt. RESULTS AND CONCLUSION: After the testing of the implemented functional safety features including the risk assessment and management, electrical safety, electromagnetic compatibility by accredited technical experts the translational couch system complies with the requirements of the Medical Devices Act and can be operated in terms of in-house application. The presented certification procedure can motivate other radiation departments to develop own systems for in-house usage.

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Metadata last modified: 03 Jun 2018 00:08

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