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YY 0831.2-2015Stereotactic radiotherapy system with gamma beam - Part 2: Multi—Source stereotactic radiotherapy system with gamma beam for body lesion (English PDF)

γ射束立体定向放射治疗系统第2部分：体部多源γ射束立体定向放射治疗系统

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 2, 2015

Implementation date

January 1, 2017

Scope

YY 0831.2-2015 is the English-translated version of γ射束立体定向放射治疗系统第2部分：体部多源γ射束立体定向放射治疗系统.

YY 0831.2-2015 is the Chinese pharmaceutical industry standard for the multi-source gamma beam stereotactic radiotherapy system used on lesions of the body, the machine that focuses a number of sealed cobalt-60 sources, moving or stationary, on a target.

It is the second part of the YY 0831 series and gives the scope, the terms and definitions, the requirements and the test methods, covering the dose rate at the focus and the size and shape of the focal dose distribution, the accuracy of the positioning and of the treatment time, the leakage radiation, the interlocks and the emergency return of the sources. Issued on 2 March 2015, it has applied since 1 January 2017.

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Document preview — YY 0831.2-2015

National Standard of the People's Republic of China

ICS: 11.040.60
Classification: C 43

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 coordinate system
4.2 random file
4.3 Focus nominal dose rates
4.4 Focus field size
4.5 Focus Wild dose gradient
4.6 positioning reference point deviation
4.7 integrated dose calculation error
4.8 treatment planning software, three-dimensional image reconstruction position error
3
4.9 Safety Requirements
5 Test Method
5.1 Coordinate System
5.2 Random Files
5.3 Focus nominal dose rates
5.4 Focus field size
5.5 Focus Wild dose gradient
5.6 positioning reference point deviation
5.7 integrated dose calculation error
5.8 treatment planning software, three-dimensional image reconstruction position error
7
5.9 Safety Requirements
Appendix A (normative) Test special body phantom measurements and focus special tools materials, structure and size

Foreword

This section drafted in accordance with GB/T 1.1-2009 given rules.

YY 0831 "gamma beam stereotactic radiotherapy system" is divided into two parts.

--- Part 1. head of multi-source gamma-beam stereotactic radiotherapy system;

--- Part 2. gamma-beam multi-source body stereotactic radiotherapy system. This is Part 2 YY 0831 of.

1 Scope

YY 0831 This section specifies the portion of multi-source gamma-beam stereotactic radiotherapy system scope, terms, definitions, requirements and experiment method.

This section applies to the body of the multi-source gamma-beam stereotactic radiotherapy system (hereinafter referred to as system), the system uses a plurality of 60Co Sealed Radioactive Sources (the movement may be, it can be stationary) lesions on the body region focusing irradiation.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard.

GB 9706.17-2009 Medical electrical equipment - Part 2.

GB/T 17857-1999 Medical imaging academic language (radiotherapy, nuclear medicine and radiation dosimetry equipment)

GB/T 18987-2003 Radiotherapy equipment Coordinates, movements and scales Safety requirements for medical electrical equipment YY 0637 radiation treatment planning system

YY 0831.1-2011 gamma beam stereotactic radiotherapy system - Part 1. Head-beam multi-source gamma stereotactic radiotherapy system

3 Terms and Definitions

Terms and definitions GB/T 17857-1999 and YY 0831.1-2011 defined apply to this document.

4 Requirements

4.1 Coordinate System

System should be adopted GB/T 18987-2003 in a coordinate system, the movement and scale requirements. If the other coordinate systems, should 4.2a) requirements described in the ACCOMPANYING DOCUMENTS.

4.2 Random file

Random file should contain the following (but not limited to).

a) The system uses a coordinate system, and the relationship between the coordinate system and GB/T 18987-2003 defined coordinate system;

b) radioactive source parameters comprising.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

GB 9706.17-2009

Similar standards

YY 0831.1-2011|YY 0832.2-2015|YY 0832.1-2011|YY/T 0971-2016|YY 9706.268-2022|YY/T 1981-2025

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