YY 0637-2013 (English Version) PDF

Scope: This standard applies to the design, manufacture, installation and use of radiation therapy planning systems (hereinafter referred to as RTPS); 　——applied to the design of treatment plans for radiotherapy in medical practice; 　——the input data can be input by the operator, It can also be obtained directly from other devices; 　——The output data can be printed, text and graphics for viewing, or directly output to other devices; 　——And it is expected that: Used normally by trained operators; 　•Maintained in accordance with the methods recommended in the instruction manual, and; 　•Used under the environmental and power supply conditions specified in the technical instructions.

YY 0637-2013 Referenced Document

GB 9706.17-2009 Medical electrical equipment.Part 2:Particular requirements for the safety of gamma beam therapy equipment
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-20 Update
IEC 60950-1 Information technology equipment - Safety - Part 1: General requirements*， 2024-04-20 Update
IEC 61000-4-1 Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series
IEC 61000-4-2 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test
IEC 61000-4-3 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test*， 2020-09-08 Update
IEC 61000-4-4 Electromagnetic compatibility (EMC) — Part 4-4: Testing and measurement techniques — Electrical fast transient/burst immunity test
IEC 61217 Radiotherapy equipment - Coordinates, movements and scales
IEC 62304 Medical device software - Software life cycle processes*， 2015-06-01 Update

2013 YY 0637-2013 Medical electrical equipment.Requirements for the safety of radiotherapy treatment planning systems
2008 YY 0637-2008 Medical electrical equipment.Requirement for the safety of radiotherapy treatment planning system