IEC 62083-2009 pdf Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems
![IEC 62083-2009 pdf Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems](https://www.freedocumentsdownload.com/wp-content/uploads/2023/11/20231128122404ad0f5.png)
4 General 4.1 Development Compliance with IEC 62304 requires identification of HAZARDS , assessment of their RISKS , and appropriate verification and validation of RISK CONTROLS . Demonstration of compliance with the requirements of this standard shall be included as part of the above processes, with explicit reference to each requirement of this standard. Compliance data shall be retained by the MANUFACTURER as a permanent record. Each test shall include a protocol containing all the necessary input data, sufficient detail to provide for exact reproducibility, and the expected result. A statement of compliance to this standard shall be included in the technical description. Compliance is checked by inspection of the records of the MANUFACTURER . 4.2 Testing during installation The MANUFACTURER shall provide an installation test document as part of the technical description that includes, as a minimum, performance of the ABSORBED DOSE distribution calculation algorithm tests given in 1 0.2 and tests of geometric relationships. The tests shall also demonstrate correct functioning of the RTPS hardware components and their ability to achieve predetermined results when performing TREATMENT PLANNING functions. Due to the complexity of TREATMENT PLANNING functions and the possible use of configurations beyond those specified by the MANUFACTURERS , it is usually not possible for the MANUFACTURER to demonstrate complete fitness for use of the RTPS at time of installation. The technical description shall provide explicit warnings to the RESPONSIBLE ORGANIZATION to add additional tests specific for the installation of the RTPS at the RESPONSIBLE ORGANIZATION .
It shall be possible for the OPERATOR to perform all TREATMENT PLANNING functions with the scales and coordinates of RADIOTHERAPY TREATMENT ME EQUIPMENT displayed according to the IEC 61 21 7 convention. It should also be possible for the OPERATOR to perform all TREATMENT PLANNING functions with the scales and coordinates of ME EQUIPMENT displayed according to the customization for the particular ME EQUIPMENT performed during EQUIPMENT MODELLING . In either case, the TREATMENT PLAN reports used for RADIOTHERAPY TREATMENT prescription shall show the scales and coordinates of ME EQUIPMENT according to the customization for the particular ME EQUIPMENT performed during EQUIPMENT MODELLING . The method of display of scales shall be explained in the INSTRUCTIONS FOR USE . Compliance is checked by testing and by inspection of the DISPLAY , output information and ACCOMPANYING DOCUMENTS .
- Previous:IEC 62271-112-2013 pdf High-voltage switchgear and controlgear – Part 112: Alternating current high-speed earthing switches for secondary arc extinction on transmission lines
- Next:IEC 62077-2015 pdf Fibre optic interconnecting devices and passive components – Fibre optic circulators – Generic specification
- ISO IEC 27050-4-2021 pdf Information technology — Electronic discovery — Part 4: Technical readiness
- ISO IEC 27036-1-2021 pdf Cybersecurity — Supplier relationships — Part 1: Overview and concepts
- ISO IEC 27013-2021 pdf Information security, cybersecurity and privacy protection — Guidance on the integrated implementation of ISO/IEC 27001 and ISO/IEC 20000-1
- ISO IEC 26580-2021 pdf Software and systems engineering — Methods and tools for the feature- based approach to software and systems product line engineering
- ISO IEC 24735-2021 pdf Information technology — Office equipment — Method for measuring digital copying productivity
- ISO IEC 24711-2021 pdf Information technology — Office equipment — Method for the determination of ink cartridge yield for colour inkjet printers and multi- function devices that contain printer components
- ISO IEC 23544-2021 pdf Information Technology — Data centres — Application Platform Energy Effectiveness (APEE)
- ISO IEC 23510-2021 pdf Information technology — 3D printing and scanning — Framework for an Additive Manufacturing Service Platform (AMSP)
- ISO IEC 23127-1-2021 pdf Information technology — Learning, education, and training — Metadata for facilitators of online learning — Part 1: Framework
- ISO IEC 23126-2021 pdf Information technology for learning, education and training — Ubiquitous learning resource organization and description framework
- ISO IEC 27041-2013 pdf Information technology – Security Guidance on assuring suitability and adequacy of incident investigative methods
- IEC TS 63217-2021 pdf Utility-interconnected photovoltaic inverters – Test procedure for over voltage ride-through measurements
- ISO IEC 24711-2021 pdf Information technology — Office equipment — Method for the determination of ink cartridge yield for colour inkjet printers and multi- function devices that contain printer components
- ISO IEC 23126-2021 pdf Information technology for learning, education and training — Ubiquitous learning resource organization and description framework
- IEC 60050-902-2013 pdf International electrotechnical vocabulary – Part 902: Conformity assessment
- BS ISO IEC 15420-2009 pdf Information technology一 Automatic identification and data capture techniques EAN/UPC bar code symbology specification
- BS ISO IEC 19762.5-2008 pdf Information technology一 Automatic identification and data capture (AIDC) techniques – Harmonized vocabulary Part 5: Locating systems
- BS IEC 60860-2014 pdf Radiation protection instrumentation一 Warning equipment for criticality accidents
- ISO IEC 24711-2021 pdf Information technology — Office equipment — Method for the determination of ink cartridge yield for colour inkjet printers and multi- function devices that contain printer components
- ISO IEC 24735-2021 pdf Information technology — Office equipment — Method for measuring digital copying productivity