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YY 0637-2013 English PDF (YY 0637-2008)

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YY 0637-2013English150 Add to Cart 0--9 seconds. Auto-delivery Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems Valid YY 0637-2013
YY 0637-2008English919 Add to Cart 4 days [Need to translate] Medical electrical equipment. Requirement for the safety of radiotherapy treatment planning system Obsolete YY 0637-2008


BASIC DATA
Standard ID YY 0637-2013 (YY0637-2013)
Description (Translated English) Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C43
Classification of International Standard 11.040.60
Word Count Estimation 29,244
Older Standard (superseded by this standard) YY 0637-2008
Quoted Standard GB 9706.17-2009; IEC 60601-1-2005; IEC 60601-1-2; IEC 60601-2-1-2009; IEC/TR 60788-2004; IEC 60950-1; IEC 61000-4-1; IEC 61000-4-2; IEC 61000-4-3; IEC 61000-4-4; IEC 61217; IEC 62304; IEC 62366-2007; ICRU REPORT 42-1987
Adopted Standard IEC 62083-2009; IDT
Drafting Organization Beijing Medical Device Testing
Administrative Organization National Technical Committee of Standardization for medical electrical radiation therapy, nuclear medicine and radiation Standardization Technical Committee dosimetry equipment
Regulation (derived from) State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to: radiation treatment planning system (hereinafter referred to as the RTPS) design, manufacture, installation and use, etc, applied in medical practice radiation therapy treatment planning, input input data either by the operator,

BASIC DATA
Standard ID YY 0637-2008 (YY0637-2008)
Description (Translated English) Medical electrical equipment. Requirement for the safety of radiotherapy treatment planning system
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 23,263
Date of Issue 2008-04-25
Date of Implementation 2009-12-01
Quoted Standard GB 4943-2001; GB 9706.1; GB/T 17626.1-1998; GB/T 17626.2-1998; GB/T 17626.3-1998; GB/T 17626.4-1998; GB/T 17857-1999; GB/T 18987-2003; YY 0505-2005; IEC 60601-1-4
Adopted Standard IEC 62083-2000, IDT
Drafting Organization State Food and Drug Administration, Beijing Medical Device Quality Supervision and Inspection Center
Administrative Organization National Standardization Technical Committee of Medical electrical equipment
Regulation (derived from) SFDA [2008] No. 192
Proposing organization State Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This standard applies to radiation treatment planning system (hereinafter referred to as RTPS) the design, manufacture, installation and use, etc., applied medicine to develop radiation treatment planning, input data either by operator input, can also be obtained directly from other devices, the output data can print paper map can also be directly output to other devices. This standard does not apply to user-developed and have only themselves to use RTPS, but to encourage developers in the development and use of the application of the standards. If such RTPS by developers can not directly control its use by other users to use, and instructions for the use of this system, the developers will be considered a manufacturer, must comply with this standard. RTPS mainly for software systems, this standard applies to the establishment of the system functionality required documentation and software testing requirements. Hardware security requirements are not included in this standard. Hardware security requirements, see 3. 1 and Appendix A.


YY 0637-2013                                                                                             Page 1 of 39  YY ICS 11.040.60 C 43 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA YY 0637-2013 / IEC 62083.2009 Replacing YY 0637-2008 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083.2009, IDT) ISSUED ON. OCTOBER 21, 2013 IMPLEMENTED ON. OCTOBER 1, 2014 Issued by. State Food and Drug Administration                                                                                             Page 2 of 39  Table of Contents Foreword ... 4  Introduction ... 6  1  Scope ... 8  2  Normative references ... 8  3  Terms, definitions and abbreviations... 9  3.1  Terms and definitions ... 9  3.2  Abbreviations ... 11  4  General ... 11  4.1  Development ... 11  4.2  Testing during installation ... 11  5  ACCOMPANYING DOCUMENTS ... 12  6  General requirements for operational safety ... 13  6.1  Distances and linear, and angular dimensions ... 13  6.2  RADIATION quantities ... 14  6.3  Date and time format ... 14  6.4  Protection against unauthorized use ... 14  6.5  Data limits ... 15  6.6  Protection against unauthorized modification ... 16  6.7  Correctness of data transfer ... 16  6.8  Coordinate systems and scales ... 17  6.9  Saving and archiving data ... 17  7  RADIOTHERAPY TREATMENT EQUIPMENT MODELLING and BRACHYTHERAPY SOURCE MODELLING ... 17  7.1  EQUIPMENT MODEL ... 17  7.2  BRACHYTHERAPY SOURCE MODEL ... 19  7.3  Dosimetric information ... 19  7.4  EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance   20  7.5  EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion ... 21  8  ANATOMY MODELLING ... 21  8.1  Data acquisition ... 21  8.2  Coordinate systems and scales ... 22  8.3  Contouring of regions of interest... 23  8.4  PATIENT ANATOMY MODEL acceptance ... 23  8.5  PATIENT ANATOMY MODEL deletion ... 24                                                                                              Page 3 of 39  9  TREATMENT PLANNING ... 24  9.1  General requirements ... 24  9.2  TREATMENT PLAN preparation ... 24  9.3  TREATMENT PLAN identification ... 25  9.4  TREATMENT PLAN deletion ... 25  9.5  Electronic signatures ... 26  10  ABSORBED DOSE distribution calculation ... 26  10.1  Algorithms used ... 26  10.2  Accuracy of algorithms ... 26  11  TREATMENT PLAN report ... 28  11.1  Incomplete TREATMENT PLAN report ... 28  11.2  Information on the TREATMENT PLAN report ... 28  11.3  Transmitted TREATMENT PLAN information ... 29  12  General hardware diagnostics ... 30  13  Data and code ... 30  14  Human errors in software design ... 30  15  Change in software versions ... 31  16  USE ERRORS ... 32  Annex A (Normative) Hardware safety ... 33  Annex B (Informative) Imported and exported data ... 36  Bibliography ... 37  Index of defined terms ... 38                                                                                              Page 4 of 39  Foreword  This Standard is drafted according to the rules specified in GB/T 1.1-2009. The Standard replaces YY0637-2008 Medical Electrical Equipment – Requirements for the Safety of Radiotherapy Treatment Planning Systems. Compared with YY0637-2008, the main technical changes of this Standard are as follows. — Add 3.2 Abbreviations; — Delete Chapter 3 of the previous standard; — Split the 8.1 of the previous standard INTO 7.1 and 7.2 of this Standard; — Delete Chapter 14 of the previous standard. The Standard is identical to IEC62083.2009 Medical Electrical Equipment – Requirements for the Safety of Radiotherapy Treatment Planning Systems. Our national documents that are consistent with the international documents of the Normative References of this Standard are as follows. [Translator. NIL here] For ease of use, this Standard is modified as follows. -- Modify the “international standard” to “this Standard”; -- Replace the comma “,” with a decimal point “.”; -- Delete the foreword of international standard. Please note that some contents of this Document may involve patents. The issuing authority of this Document does not undertake the responsibility of identifying these patents. This Standard was proposed by the State Food and Drug Administration. This Standard shall be under the jurisdiction of National Standardization Technical Committee of Medical Appliances Radiotherapy and Technical Committee of Nuclear Medicine and Radiation Dosimetry Equipment (SAC/TC10/SC3). Main drafting organizations of this Standard. Beijing Institute of Medical Device Testing, Shandong Shinva Medical Instrument Co., Ltd., and Shanghai Song’s Lab Science and Technology Development Co., Ltd. Main drafters of this Standard. Song Lianyou, Wang Peichen, Yin Xiaohui, and Cao Guogang.                                                                                             Page 5 of 39  This Standard was first-time issued in 2008. ......


YY 0637-2008 Medical electrical equipment.Requirement for the safety of radiotherapy treatment planning system ICS 11.040.50 C43 People's Republic of China pharmaceutical industry standards YY 0637-2008/IEC 62083.2000 Medical electrical equipment - Safety requirements for radiation treatment planning system (IEC 62083.2000, IDT) Posted 2008-04-25 2009-12-01 implementation State Food and Drug Administration issued Table of Contents Introduction Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Relationship with other standard 2 4 Terms and definitions 2 5 General test requirements 2 6 3 accompanying documents 7 General requirements for the safe operation of 4 8 radiotherapy and brachytherapy device configuration data source 5 9 virtual patients to establish 7 10 treatment planning 8 11 absorbed dose distribution calculation 9 12 Treatment Project Report 10 13 11 General hardware diagnostic requirements 14 arithmetic processor 11 Data and code 15 11 16 11 Software Design of human error 17 software version 11 changes 18 Using human error 12 Appendix A (normative) hardware security 13 Annex B (informative) input and output data 15 Annex C (normative) terms index 16 Table 1 accompanying document should be included in this standard clauses 3 Table A. 1 Change Table 13 YY 0637-2008/IEC 62083.2000 Foreword YY 0637 "Safety requirements for medical electrical equipment Radiation Treatment Planning System" identical with IEC 62083.2000. For ease of use, this standard made the following editorial changes. a) By deleting IEC 62083.2000 Foreword; b) use the "standard" instead of "this International Standard"; c) In Chapter 2, "Normative references", the press of GB/T 1.1-2000 increased introductions. The Standard Appendix A, Appendix C are normative appendices; Appendix B is an informative annex. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee appliances medical radiotherapy, nuclear medicine and radiation dosimetry equipment Standardization Technical Committee It will be centralized. This standard was drafted. State Food and Drug Administration, Beijing Medical Device Quality Supervision and Inspection Center, Beijing Medical Equipment Institute The study. The main drafters of this standard. There SONG Lian Qu Guihong, Wang Peichen. YY 0637-2008/IEC 62083.2000 introduction Radiation treatment planning system (radiotherapytreatmentplanningsystem) (hereinafter referred to as RTPS) it is usually a programmable Electronic system used to simulate the role of radiation therapy for the purpose of application of radiation to the patient. Typically (but not necessarily), the use of a special Given algorithm or more algorithms, provide an estimate of human tissue absorbed dose distribution. Estimated absorbed dose distribution, as defined in this standard, only Treatment planning process is the use of personnel having recognized qualifications. The output RTPS as an important information for obtaining the accreditation of personnel in the treatment planning process. Input data is not Accurate algorithm limitations, inappropriate use of the treatment planning process errors, or output data, these results may use in the course of treatment A safety hazard to the patient. This standard specifies the manufacturers in the design and construction process RTPS requirements to be observed in order to prevent this These hazards occur. This standard does not specify the input data and the calculation algorithm type, because it depends on many factors such as. technical conditions, user habits, develop The type of treatment plan. Nevertheless, this standard to establish a common safety requirements for the algorithm, and the establishment of minimum requirements for the accompanying documents to It enables users to make choices known in the treatment planning process. Note. Due to RTPS does not act directly on the patient, and therefore does not belong to RTPS Medical electrical equipment as defined in GB 9706.1. As a result of this standard does not GB 9706.1 specific standard, so different from the use of GB 9706.1 independent writing format. Chapter 3 contains the relevant information. YY 0637-2008/IEC 62083.2000 Medical electrical equipment - Safety requirements for radiation treatment planning system 1 Scope This standard applies to radiation treatment planning system (hereinafter referred to RTPS) the design, manufacture, installation and use of such areas; --- Used in medicine to develop radiotherapy treatment planning; --- Data input either by an operator input, can also be obtained directly from other devices; --- Output data can print paper map can also be exported directly to other devices; --- And provides as follows. ● as a routine use, the operator should have the skills and training they need and have a license; ● should be used according to the method recommended maintenance instructions, and; ● comply with the technical specifications required by environmental and power supply conditions. This standard does not apply to user-developed and only RTPS own use, but developers are encouraged to use this standard in the development and use. If such RTPS was developed by those who can not directly control its use by other users to use, and a description of this system is suitable for use, then Developers will be considered for the manufacturer and must comply with this standard. RTPS major software system, purpose of this standard is to establish the required functionality of the system, the test requirements documents and software. hard Safety requirements for members are not included in this standard. Security hardware requirements see 3.1 and Annex A. 2 Normative references The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB 4943-2001 Safety of information technology equipment (including electrical business equipment) GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT) GB/T 17626.1-1998 Electromagnetic compatibility testing and measurement techniques Immunity Test Subjects (idt IEC 61000-4-1. 1992) GB/T 17626.2-1998 Electromagnetic compatibility - Testing and measurement techniques - Electrostatic discharge immunity test (idt IEC 61000-4-2. 1995) GB/T 17626.3-1998 electromagnetic compatibility test and measurement technology RFEMS test (Idt IEC 61000-4-3.1995) GB/T 17626.4-1998 Electromagnetic compatibility - Testing and measurement techniques - Electrical fast transient burst immunity test (Idt IEC 61000-4-4.1995) GB/T 17857-1999 Medical imaging academic language (radiotherapy, nuclear medicine and radiation dosimetry equipment) (eqv IEC 60788. 1984) GB/T 18987-2003 Radiotherapy equipment Coordinates, movements and scales (IEC 61217.1996, IDT) YY 0505-2005 Medical electrical equipment - Part 1. General Requirements for Safety 2. Collateral Standard. Electromagnetic Compatibility requirements and test Test method (IEC 60601-1-2.2001, IDT) IEC 60601-1-4 Medical electrical equipment - Part 1. General Requirements for Safety 4. Collateral standard. programmable electronic medical systems YY 0637-2008/IEC 62083.2000 ......

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