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YY 0831.2-2015 English PDF

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YY 0831.2-2015: Stereotactic radiotherapy system with gamma beam. Part 2: Multi-Source stereotactic radiotherapy system withgamma beam for body lesion
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY 0831.2-2015299 Add to Cart 3 days Stereotactic radiotherapy system with gamma beam. Part 2: Multi-Source stereotactic radiotherapy system withgamma beam for body lesion Valid

Similar standards

YY 0832.1   YY/T 0840   YY 0831.1   YY 0832.2   

Basic data

Standard ID: YY 0831.2-2015 (YY0831.2-2015)
Description (Translated English): Stereotactic radiotherapy system with gamma beam. Part 2: Multi-Source stereotactic radiotherapy system withgamma beam for body lesion
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C43
Classification of International Standard: 11.040.60
Word Count Estimation: 14,136
Date of Issue: 2015-03-02
Date of Implementation: 2017-01-01
Quoted Standard: GB 9706.1-2007; GB 9706.15-2008; GB 9706.17-2009; GB/T 17857-1999; GB/T 18987-2003; YY 0637; YY 0831.1-2011
Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard specifies the body of multi-source ��-beam stereotactic radiotherapy system scope, terms, definitions, requirements and test methods. This Standard applies to the body of the multi-source ��-beam stereotactic radiosurgery consistent treatment system, which use multiple 60Co sealed radioactive sources (which may be movement, can also be stationary) lesions on the body region irradiated bunching.

YY 0831.2-2015: Stereotactic radiotherapy system with gamma beam. Part 2: Multi-Source stereotactic radiotherapy system withgamma beam for body lesion


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Stereotactic radiotherapy system with gamma beam Part 2. Multi-Source stereotactic radiotherapy system with gamma beam for body lesion ICS 11.040.60 C43 People's Republic of China pharmaceutical industry standards γ beam stereotactic radiotherapy system Part 2. The body of multi-source beam stereotactic γ Radiation therapy system Part 2. Multi-Sourcestereotacticradiotherapysystemwith Issued on. 2015-03-02 2017-01-01 implementation China Food and Drug Administration released

Table of Contents

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Requirements 1 4.1 coordinate system 1 4.2 random file 1 4.3 Focus nominal dose rates 2 4.4 Focus field size 2 4.5 Focus Wild dose gradient 2 4.6 positioning reference point deviation 3 4.7 integrated dose calculation error 3 4.8 treatment planning software, three-dimensional image reconstruction position error 3 3 4.9 Safety Requirements 5 Test Method 3 5.1 Coordinate System 3 5.2 Random Files 3 5.3 Focus nominal dose rates 3 5.4 Focus field size 4 5.5 Focus Wild dose gradient 5 5.6 positioning reference point deviation 5 5.7 integrated dose calculation error 5 5.8 treatment planning software, three-dimensional image reconstruction position error 6 7 5.9 Safety Requirements Appendix A (normative) Test special body phantom measurements and focus special tools materials, structure and size 8

Foreword

This section drafted in accordance with GB/T 1.1-2009 given rules. YY 0831 "γ beam stereotactic radiotherapy system" is divided into two parts. --- Part 1. head of multi-source γ-beam stereotactic radiotherapy system; --- Part 2. γ-beam multi-source body stereotactic radiotherapy system. This is Part 2 YY 0831 of. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This part is proposed by the China Food and Drug Administration. This part of the National Technical Committee of Standardization for medical appliances for radiotherapy, nuclear medicine science equipment at the Technical Committee and the radiation dose (SAC/TC10/SC3) centralized. This section is drafted. Beijing Medical Device Testing XI'AN integrated medical technology Co., Ltd. Shenzhen Beauvois new medical technologies made Exhibition Limited. The main drafters of this section. Zhang, SONG Lian there, before Meng, Yang rivers, Huguang Yong. γ beam stereotactic radiotherapy system Part 2. The body of multi-source beam stereotactic γ Radiation therapy system

1 Scope

YY 0831 This section specifies the portion of multi-source γ-beam stereotactic radiotherapy system scope, terms, definitions, requirements and experiment method. This section applies to the body of the multi-source γ-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. medical electrical systems security Claim GB 9706.17-2009 Medical electrical equipment - Part 2. γ beam therapy equipment requirements for the safety 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 γ beam stereotactic radiotherapy system - Part 1. Head-beam multi-source γ 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.
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