GB 9706.17-2009 English PDFGB 9706.17: Historical versions
Basic dataStandard ID: GB 9706.17-2009 (GB9706.17-2009)Description (Translated English): Medical electrical equipment -- Part 2: Particular requirements for the safety of gamma beam therapy equipment Sector / Industry: National Standard Classification of Chinese Standard: C43 Classification of International Standard: 11.040.60 Word Count Estimation: 35,363 Date of Issue: 2009-11-15 Date of Implementation: 2010-12-01 Older Standard (superseded by this standard): GB 9706.17-1999 Adopted Standard: IEC 60601-2-11-1997, IDT Regulation (derived from): Announcement of Newly Approved National Standards No. 13 of 2009 (No. 153 overall) Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China Summary: This Chinese standard applies to practice in human medicine for therapeutic purposes �� radiation beam therapy equipment safety requirements, which include programmable electronic systems PES (programmable electronic system) control to select and display equipment operating parameters, bb) the specific criteria applicable to the use of sealed radioactive sources in the normal treatment distance (NTD) provided at �� greater than 5cm beam device when the device is in a more close work, you may need special precautions, this standard also applies to many dedicated source stereotactic radio surgery and radiotherapy (MSSR) equipment, which also sealed radioactive sources with more than one such center on an irradiated. Source may be static, it can be moved, cc) the specific standard applies to: the authorized officer or qualified personnel under the supervision of medical applications with special skills to work in accordance with the instructions to use the equipment operator, during a predetermined period of maintenance equipment, routine testing by the user equipment, clinical applications with special equipment required, such as: fixed or moving beam radiation therapy Radiation therapy equipment, dd) type testing and on-site inspection under the respective requirements, the special standard applies to �� beam therapy equipment manufacturing and installation, ee) only provides the specific standards for equipment requirements, the requirements for radioactive sources are not specified. GB 9706.17-2009: Medical electrical equipment -- Part 2: Particular requirements for the safety of gamma beam therapy equipment---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. Medical electrical equipment.Part 2. Particular requirements for the safety of gamma beam therapy equipment ICS 11.040.60 C43 National Standards of People's Republic of China GB 9706.17-2009/IEC 60601-2-11.1997 Replacing GB 9706.17-1999 Medical Electrical Equipment Part 2. γ beam therapy equipment requirements for the safety (IEC 60601-2-11.1997, IDT) Published 2009-11-15 2010-12-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China issued Table of ContentsPreface Ⅰ Introduction Ⅱ The first chapter outlines 1 And a range of object 1 2 Terms and Definitions 2 General claim 4 Test 4 5 Category 5 6 to identify, mark and file 6 The second environmental conditions 8 10 environmental conditions 8 Title III of the danger of electric shock protection 8 8 and shield 16 of the housing 18 protective earth, and ground potential equalization function 8 19 Continuous leakage currents and patient auxiliary current 9 9 20 Dielectric Strength Title IV of protection against mechanical hazards 9 21 Mechanical strength 9 22 moving member 10 27 pneumatic and hydraulic power 10 28 pedants 11 The fifth chapter of unnecessary or excessive radiation hazard protection 11 29 X 11 radiation Title VI protection 23 pairs mixed flammable anesthetic gas ignition hazard Title VII of the ultra-mild other security risk protection 23 23 accuracy and prevent the risk of data output from the eighth chapter of the work Chapter 9. abnormal operating and fault states; Environmental Testing 23 Tenth chapter 23 structural requirements Mains supply portion 57, and the wiring 23 Component Appendix 27 Annex L (normative) Normative References 27 Annex AA (informative) terms index 28 GB 9706.17-2009/IEC 60601-2-11.1997ForewordAll technical contents of this section is mandatory. "Medical Electrical Equipment" safety standard series consists of two parts. --- Part 1. General requirements for safety; --- part 2. requirements for the safety. This section requirements for safety, is part of the 17 GB 9706. This section is equivalent to using IEC 60601-2-11.1997 "Medical Electrical Equipment Part 2. γ beam therapy equipment General requirements for safety" And Amd1.2004. For ease of use, this section following editorial changes made. --- deleted international standards foreword; --- For other standards referenced international standards, Ruoyi into our standard, replacing this part with our corresponding international Standard Standard; --- with a decimal point "." Decimal points "." This partial replacement GB 9706.17-1999 "Medical Electrical Equipment Part 2. γ beam therapy equipment requirements for the safety." This compared with GB 9706.17-1999 main portion changes as follows. --- increased the instructions in Appendix nature. --- The GB 9706.17-1999 text "must (original shal)" translated as "shall" and other editorial changes. --- The IEC 60601-2-11Amd1. contents 2004 added to this section. Annex L of this portion is a normative, Annex AA is an information appendix. This section proposed by the State Food and Drug Administration. This part of the jurisdiction of the National Medical Electrical Standardization Technical Committee (SAC/TC10). This section was drafted. Beijing Medical Device Testing. The main drafters of this section. Chapter trillion Park, Wang Peichen, Chen Jing, Miao Bin. This section replaces the following previously issued as follows. --- GB 9706.17-1999. GB 9706.17-2009/IEC 60601-2-11.1997IntroductionUsed for therapeutic purposes γ radiation beam therapy equipment, such as a patient if desired dose emitted or equipment failure If the design of such equipment can not meet the safety standards for electrical and mechanical, it may make the patient suffer damage. If the device itself Fault contain enough radiation and (or) improper treatment room design, the device may also cause damage to nearby people. 1 as part of this determination based on the manufacturer in the design and manufacture of the γ beam therapy equipment aspect. In order to avoid unsafe condition The interruption or termination of irradiation, interlocks should prevent exceeding the tolerance limits specified in Chapter 29. Type tests done by the manufacturer, site inspection Not every pair of specified requirements shall be completed by the manufacturer. Chapter 29 does not attempt to determine the best performance requirements for the γ beam radiotherapy apparatus, and its object is to determine the recognized today As for the safe operation of such equipment essential for these design features. It can be speculated that it is limited to applying a fault condition Member decreases device performance. For example, when a member fails, then an interlock to prevent operation of the respective there continue provided run. Before installing the equipment, it should be fully understood only certificates of compliance related to the type test the manufacturer can provide. By the field inspection The resulting data should be written in the form of on-site inspection reports of people accompanying documents, after passing these tests before installing the equipment. IEC 60601-2-11Amd1.2004 for multi-source stereotactic radiosurgery and radiotherapy (MSSR). Although IEC 60601 Comprising a multi-source stereotactic radiotherapy apparatus, some definitions are not suitable for the current requirements and some special types of equipment. This amendment The introduction of some new terminology. This section 4.1aa) Note pointed out. "γ beam therapy each set of radiation safety inspection requirements in some countries have been included in the regulations." at me State radiation safety inspection requirements, γ beam therapy equipment belongs to the category of mandatory standards. This section 29.4.5c) mentioned "as used 'DeconF5 or RBS25'", when used in embodiments of the standard "ethylenediaminetetraacetic Sodium salt (EDTA) "instead. This section 29.5.5.1 and 29.5.5.2, are not used for the entire device does not apply a filter. Associated with this section IEC 60601-1 (including the revised document) and juxtaposed in the standard as 1.3. GB 9706.17-2009/IEC 60601-2-11.1997 Medical Electrical Equipment Part 2. γ beam therapy equipment requirements for the safety The first chapter outlines Except as follows, "General Standard" chapter in the chapter, shall apply.1 Scope and purposeExcept as follows, "General Standard" This is applicable. 1.1 Scope supplement. aa) This standard specifies specific safety requirements for radiation therapeutic purposes in human medicine practice γ beam therapy equipment, which package It comprises programmable electronic systems controlled by the selected PES (programmableelectronicsystem) and a display operating parameters equipment; bb) This standard applies to dedicated sealed radioactive sources used in normal treatment distance (NTD) provided at greater than 5cm γ beam apparatus, When the device is in the closer job, it may require special precautions; This also applies to multi-specific standard source stereotactic radiosurgery and radiotherapy (the MSSR), the apparatus simultaneously with more than one A sealed radioactive sources for irradiating a center like. Source may be stationary or may be movable; cc) This standard applies to dedicated. --- under the supervision of authorized personnel or qualified personnel, the press has a special medical applications using the skills of the work instructions To use the operation device; --- maintenance of equipment within a predetermined period; --- carry out routine testing of the device by the user; --- special provisions clinical devices such as. a fixed or mobile radiation treatment beam radiation therapy device; dd) The type test and each test site requirements, the specific standards for the manufacture and installation of γ beam therapy device; ee) This standard specifies only special equipment requirements, requirements for radioactive sources is not specified. 1.2 Purpose supplement. aa) This standard specifies specific safety requirements for γ radiation beam therapy equipment used in human medical practice, to ensure that the device Radiation safety, enhance the safety of electrical and mechanical equipment, but also provides equipment to verify whether these safety and special Full match test requirements; bb) this specific standard defined by the type of apparatus, an absorption dose) is controlled by the irradiation time. This part does not include other methods Tolerance control absorbed dose produced. 1) In the present specific standard, all values mentioned in the absorbent refers to the maximum absorbed dose in water depths built. 1.3 Specific Standard supplement. This is a specific standard GB 9706.1-2007. modifications and additions "Medical Electrical Equipment Part 1 General Requirements for Safety," the. GB 9706.1-2007 as the "General Standard", this specific standard with the "General Standard", as on the compliance requirements of the verification test Rear. "This part" means "General Standard" and this specific standard. The articles in this special standard, consistent with chapter numbers, bar and "common standards". For the "common standards" to change the text, use the provisions under GB 9706.17-2009/IEC 60601-2-11.1997 Column each word. "Instead of" means "General Standard" Chapter strip or entirely replaced by the standard-specific chapter or section. "Complementary" refers to specific provisions of this Standard requires added "General Standard" in. "Modify" means "General Standard" Chapter specific standard or strip as is indicated by the provisions that has been modified. For added that "universal standards" in terms or drawing numbered starting from 101, supplemented by letters of Appendix AA, BB and so marked, add Project with aa), bb), etc. represent. Not at this specific standard in the corresponding chapter, chapter or article, the "General Standard" in the article, or chapter shall apply, without making a change. This section, along with parallel standard YY0505 appreciated together, using, in addition, no other applicable standards in parallel. It should be noted that any suitable part of the "General Standards", in this specific standard explanation has been given, although these parts This may correspond to specific standard. If the present standard-specific requirements for certain requirements of a "universal standards" in place of or changes made, it takes precedence over the "General Standard" Those requirements.2 Terms and Definitionssupplement. Note. Appendix AA Alphabetical list of definitions of terms and their provenance. Supplementary definition. 2.101 The radiation source is completely shielded state, but also in a position of safety. 2.102 The radiation source in the radiation therapy completely exposed state. 2.103 Abbreviations. The timer abbreviation. timer Means for measuring the irradiation time, irradiation and terminates at a predetermined time. 2.104 It referred to the radiation field size. 2.105 And the radiation head supporting member to complete a variety of possible movement of the device. 2.106 From the center of the front surface of the radiation source to see, in a plane perpendicular to the beam axis, the end of the geometric projection beam limiting device. The shape of the radiation field Beam-limiting aperture of the same apparatus. Wild geometric dimensions can be defined at any distance from the radiation source. 2.107 Stop or stop irradiation of radiation, in the absence of re-selection of operating conditions (ie return to the ready state), and is likely to continue irradiation movement. 2.108 The distance along the axis of the radiation beam from the radiation source to isocenter. Or non-isocentric devices, to a predetermined distance from the plane. GB 9706.17-2009/IEC 60601-2-11.1997 2.109 Combination of two timer, a timer is used as the primary, the other secondary channels are used for the timer. 2.110 When the time reaches a preselected value, controls the timer to terminate the irradiation. 2.111 It contains a wide range of programmable device, comprising a microprocessor, programmable controllers, programmable logic controllers, and other meter A base member including a computer, the apparatus may further comprise a sensor, and (or) a central processing unit connected to a transmission, for controlling System, protection or monitoring. 2.112 Approved by the competent authority personnel with the necessary knowledge and trained to complete the prescribed duties. 2.113 Combination of two of the timer, when the time reaches the selected value, two timers may terminate the irradiation. 2.114 The surface of the mold body at a certain distance, the radiation beam with an absorbed dose at a depth into the mold body measured along a radiation beam axis 0.5mm Axis of maximum absorbed dose ratio. 2.115 When the master clock fails, the control timer to terminate the irradiation. 2.116 After the installation of a piece of equipment or devices or inspection, to verify compliance with the required standards. 2.117 Irradiation of termination or termination of irradiation, if you do not re-select all operating conditions (ie, back or return to ready state), non-irradiated Re-start. --- When the elapsed time reaches a preselected value; --- or manual operation by a human; --- or by the action of interlocking; Or when --- due gantry angular position reaches a preselected value at the mobile beam radiation therapy. 2.118 For purposes of treatment, the prescribed embodiment of a process or a portion thereof. 2.119 In radiation therapy, the patient need irradiated surface area. 2.120 By the manufacturer of the instrument or device a specially designed test done to determine if the design meets the required standards. GB 9706.17-2009/IEC 60601-2-11.1997 2.121 Are provided in the apparatus without the beam limiter i.e. interlock prevents irradiation occurs, i.e., zero beam limiter is of such a bypass from the interlock Device. 2.122 Three-dimensional multi-source center for the treatment of head and the like in the MSSR beam limiter system (MIBLS). 2.123 Relative MIBLS, a stereotactic frame moved and adjusted to vary the area to be treated. 2.124 MIBLS retracted position to be able to re-placement of the frame. 2.125 Put the device back to the beam to move from state to complete the re-placement site, and the site to put back the return beams from desired state time. 2.126 External frame as the reference method for positioning a three-dimensional human body points. 2.127 MIBLS shutter opens to the carrier or is in between the source position and the treatment position at the treatment of the carrier to the source device or MIBLS Time the shutter is closed. 2.128 Received transmission time dose. General requirements Test 4 Except as follows, "General Standard" This is applicable. 4.1 Test supplement; aa) This portion of the test method is generally divided into three levels, and requires the following. Class A. In the case of the type of test. the working principle and method configured to meet the design requirements of the analysis apparatus, such a requirement spokes Fire safety precautions, etc., the results should provide an explanation in the ACCOMPANYING DOCUMENTS. In the case of on-site inspection. random test data file requested. Class B. Visual inspection of the device or function test or measurement test method specified in this section shall be, and should be in the operating state (including so Fault condition) does not interfere under the premise of a circuit or to complete the configuration of the device. Class C. Function test or measuring equipment, test principles defined in this section shall, should be included in the technical specification field test. GB 9706.17-2009/IEC 60601-2-11.1997 When the operating state of the process contains circuits or structures requiring intervention equipment, or the manufacturer should test the manufacturer directly monitor Governor carried out under. This is not a predetermined specific standard test methods γ beam therapy equipment in the working life cycle testing and inspection cycle. Note. radiation safety inspection requirements γ beam therapy equipment, and in some countries have been included in legislation. 4.6 Other conditions supplement. aa) Technical specification information should be provided on-site testing, which include the following, --- Class A type test results; --- Class B and C type test results and rules; --- special methods and test conditions for on-site inspection of the C-Class; --- described how to generate a fault condition as described, or, if not described failure state, then how to generate A test signal is closely related to the occurrence of the fault signal when a fault is generated, and verify that the test signal simulates particular it Source of failure in the fault condition; Note. In some cases, an analog test signal may be more than one fault condition. --- Description After the on-site inspection, how to restore the device to normal use, and instructions on how to verify the status. By examining a random file, check whether it meets the requirements. Personnel responsible for on-site inspection of the test results shall be recorded in the report, and as part of a random file. In addition, on-site inspection Report should contain at least the following. a) The name and address of the customer site; b) or a device model and serial number of model parameters; c) All participants inspectors name, department, address and date; d) Environmental conditions and supply conditions; Real e) when the predetermined check condition, device manufacturer, or different methods, or can not be obtained from the relevant information when the present specific standard Actual situation. Note. The site inspection need not be done by the manufacturer. 4.8 Pretreatment supplement. aa) This test applies only to condition the device member has been done by wet Pretreatment 4.10 predetermined. 4.10 humidity preconditioning supplement. aa) Random files should indicate the following pieces of equipment. --- susceptible to damp impact member pretreatment simulated climatic conditions; --- been tested under the conditions set member. By examining a random file, check whether it meets the requirements. Category 5 instead. Classification apparatus described in Chapter 6 shall be marked and (or) identification. 5.1 by type of protection against electric shock of points. This device is part of the class Ⅰ device should meet. GB 9706.17-2009/IEC 60601-2-11.1997 5.2 according to the degree of protection against electric shock of points. In addition to the MSSR, compliance with this device shall be B type apparatus, MSSR equipment should BF type B or type. 5.3 according to the degree of protection against harmful inlet point. Unless otherwise specified, shall comply with this part of the device is a common equipment (i.e., does not prevent the closure device into the liquid). 5.4 recommended by the manufacturer for use disinfection or sterilization methods points. Unless otherwise specified, compliance with this device should be steril......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.17-2009_English be delivered?Answer: Upon your order, we will start to translate GB 9706.17-2009_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB 9706.17-2009_English with my colleagues?Answer: Yes. 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