YY 0832.2-2015_English: PDF (YY0832.2-2015)
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Stereotactic and planning system for radiotherapy with X-radiation. Part 2: Stereotactic and planning system for radiotherapy with X-radiation for body lesion
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YY 0832.2-2015
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Standard ID | YY 0832.2-2015 (YY0832.2-2015) | Description (Translated English) | Stereotactic and planning system for radiotherapy with X-radiation. Part 2: Stereotactic and planning system for radiotherapy with X-radiation 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 | 8,851 | Date of Issue | 2015-03-02 | Date of Implementation | 2017-01-01 | Quoted Standard | GB 9706.5; GB 15213; GB/T 17857; GB/T 18987; YY 0637 | Drafting Organization | Beijing Medical Device Testing | Administrative Organization | National Medical Electrical Standardization Technical Committee radiotherapy, nuclear medicine and radiation dosimetry equipment Sub-Technical Committee | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | Proposing organization | China Food and Drug Administration | Issuing agency(ies) | China Food and Drug Administration | Summary | This Standard specifies the scope, terms, requirements and test methods portion of X-radiation and stereotactic radiotherapy planning system. This section applies to the body portion of X-radiation and stereotactic radiotherapy planning system. The system is used in conjunction with medical electron accelerators, the lesion area of ??the body stereotactic radiotherapy. |
YY 0832.2-2015
Stereotactic and planning system for radiotherapy with X-radiation.Part 2. Stereotactic and planning system for radiotherapy with X-radiation for body lesion
ICS 11.040.60
C43
People's Republic of China pharmaceutical industry standards
X-radiation and stereotactic radiotherapy planning system
Part 2. X-radiation body stereotactic radiotherapy
And planning system
Part 2. Stereotacticandplanningsystemfor
Issued on. 2015-03-02
2017-01-01 implementation
China Food and Drug Administration released
Foreword
This section drafted in accordance with GB/T 1.1-2009 given rules.
YY 0832 "X radiation and stereotactic radiotherapy planning system" is divided into two parts.
--- Part 1. Head X-radiation and stereotactic radiotherapy planning system;
--- Part 2. body X-radiation and stereotactic radiotherapy planning system.
This is Part 2 YY 0832 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, PLA General Hospital, Shandong Xinhua Medical Instrument Company Limited
Secretary, Dalian modern high-tech Holdings Limited.
The main drafters of this section. Coke spring camp, Wang Suoting, into Greek leather, Jun Han.
X-radiation and stereotactic radiotherapy planning system
Part 2. X-radiation body stereotactic radiotherapy
And planning system
1 Scope
YY 0832 This section defines the scope of application of the body X-radiation and stereotactic radiotherapy planning system, terminology, requirements and test
Test methods.
This section applies to a body of X-radiation and stereotactic radiotherapy planning system (hereinafter referred to as the system). The electronic processing system and medical
Speed with the use of the body lesion area stereotactic radiotherapy.
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 9706.5 Medical electrical equipment - Part 2. 1MeV to 50MeV energy requirements for the safety of electron accelerators
GB 15213 Medical Electron Accelerator and test methods
GB/T 17857 Medical imaging academic language (radiotherapy, nuclear medicine and radiation dosimetry equipment)
GB/T 18987 Radiotherapy equipment Coordinates, movements and scales
Safety requirements for medical electrical equipment YY 0637 radiation treatment planning system
3 Terms and Definitions
GB 15213, GB 9706.5, terms and definitions GB/T 17857 apply as defined in this document.
4 Requirements
4.1 Coordinate System
System should be adopted GB/T 18987 in the coordinate system, the movement and scale requirements. If the other coordinate systems, should 4.2a) of
Requirements described in the ACCOMPANYING DOCUMENTS.
4.2 random file
Random file must contain at least the following.
a) The system uses a coordinate system and coordinate relations with GB/T 18987 defined coordinate system;
b) with the use of medical electron accelerator (hereinafter referred to as accelerator) shall comply with the requirements of GB 15213 and GB of 9706.5;
c) with the use accelerator energy range;
d) collimator parameters, including the number, number, height, two-port nominal size;
With the use of after e) collimator assembly accelerator radiation field size set in consultation with the manufacturer and with the use of accelerators given
Radiation field is set correctly sized safety programs;
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