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

Standard Number:  GB 9706.1-2007
Title:  Medical electrical equipment - Part 1:General requirements for safety
Language:  Simplified Chinese
Publication Date:  2007/7/2
Execute Date:  2008/7/1
Status:  Current
Standard Type:  Safety
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Medical equipment
Publisher:  Chinese Standards(GB)
Price:175.20  
Number of Pages:146  

Description:This standard applies to the safety of medical electrical equipment.
although this standard is primarily concerned with security issues, but it also includes some of the reliable operation of the safety related requirements.
the equipment covered by this standard is expected as a result of physiological effects of security risk has not been considered.
unless expressly indicate the standards body, the standard of the appendix content does not require compulsory execution.  
Cross References:
IEC 60601-1-1988,
  
Catalog: Preface first overview Ⅴ scope and purpose  1 1 1 general requirements for terms and definitions 1 2 3 4 13 general 14 5   test classification 16 June to identify, mark and file 16 July 24 August 23 second input power environment conditions Basic safety type 24 9 removable protection 24 no general requirements, environmental conditions 24 November 25 12 no general requirements 25 third article 13 overview of shock hazard protection 25 25 14 about the classification of the requirements of 25 15 voltage and (or) energy The limit of 26 16 17   shell and cover of 26 isolation (the original title: insulation and protection of impedance) 28 18 protection grounding, function and potential balance 30 19 patients with continuous leakage current and auxiliary current 37 fourth article 31 20 dielectric strength of mechanical risk prevention Protection of 40 21 mechanical strength 40 22  42 23 surface movement part, Angle and edge 42 24 stability of 42 normal use 25 flying objects 43 26  43 27 vibration and noise of pneumatic and hydraulic power 28 hanging objects 43 fifth article 43 Or you don't need too much radiation hazard protection 44 29 X ray radiation 44 30 alpha, beta, gamma, neutron radiation and other particle radiation 44 45 32 optical radiation and microwave radiation (including laser) 45 33 infrared radiation 45 34 45 35 ultraviolet (uv) radiation Sound energy (including ultrasound) 45 36  electromagnetic compatibility sixth article 45 Protection of inflammable anaesthesia mixture ignites dangerous 45 37 position and basic requirements of 45 38 46 39 mark, random file to the common requirement of the AP and APG equipment 46 40 type of AP The requirement of equipment and parts and components and 47 41 of APG type test equipment and parts and components requirements and testing seventh article 49 Risk of overheating and other safety protection 50 42 overtemperature 50 fire 54 43 44 overflow, liquid splashing, leak, be affected with damp be affected with damp, into the liquid, Cleaning, disinfection, sterilization, and compatibility of 54 45 pressure vessel and pressure 55 46 human error 56 47 electrostatic charge 56 48 biocompatibility 49 to 56 the interruption of power supply 56 8 output data and the accuracy of dangerous work to prevent 57 50 job data The accuracy of the 57 51 57 article 9 dangerous output to prevent abnormal running state and fault; 57 52 environmental testing is not normal operation and fault condition of 57 53 environment test 61 in the first ten structure requires 61 54  overview of 55 shell and cover 61 61 56 components and component 62 57 66 58 net power supply parts, components and wiring protective earthing - structure and wiring terminal and the connection of 59, 74, 74 appendix A (informative appendices) always guide and manual 101 appendix B (informative appendices) manufacturing and (or) at the time of installation Experiment 124 appendix C (informative appendices) order 124 appendix D (normative appendix) marked with symbols 127 appendix E (informative appendices) insulation path of inspection and testing circuit 129 appendix F (informative appendices) flammable mixture test unit 133 appendix G (normative appendix) impact test device 134 appendix H (informative appendices) with threaded connection terminals 134 appendix J (informative appendices) power transformer 134 appendix K (normative appendix) when the patient leakage current measurement application part of the connection (see chapter 19) 135 appendix L (normative appendix) normative reference files of 137 the atmospheric conditions given in table 1 and table 2 equipment external markers 17 table 3 the color of the light is recommended and its meaning 21 patients with continuous leakage current and auxiliary current table 4 the permissible value of 33 table 5 fall high test voltage 39 table 8 Degrees 41 table 9 wires into the line of the inlet air tightness 49 table 10 a) allow the highest temperature of 50 table 10 b) allow the highest temperature of 51 table 11 fault state of the highest temperature 58 table 12 electromotor winding temperature limit of 59 table 13 test torque rotary controller 65 tables 15 power soft wire cross-sectional area in the name of the 67 table 18 fixed with soft wire parts test table 19 when environment temperature is 25 ℃ 68 net power transformer winding overload and short circuit conditions allow the highest temperature 70 table 20 power transformer test current 71 table 16 creepage distance and clearance of 74 Figure 1 terminal and illustrations of the wire (see chapter 2), 77 figure 2 Ⅰ illustrations of such equipment (see 2.2.4) 78 figure 3 with metal shell Ⅱ illustrations of such equipment (see 2.2.5) 78 general requirements for figure 4 no 79 figure 5 removable network power supply connection (see chapter 2) General requirements for 79 figure 6 no 79 figure 7 standard test (see chapter 16) 80 figure 8 test needle hook (see chapter 16) 80 figure 9 test (see chapter 16) 81 figure 10 when one end of the supply network approximate potential measurement of the power supply circuit [19.4 b)] is shown in figure 1, 81 1 supply network to approximate symmetrical potential measurement of the power supply circuit [19.4 b)] 81 figure 12 pick up to supply network of multiphase equipment of measuring power supply circuit [19.4 b)] 82 figure 13 regulation supply network connect up to phase measurements of single-phase equipment of the power supply circuit [19.4 b)], 82 Figure 14 class by Ⅰ by rules or Ⅱ single-phase power supply equipment of power supply circuit 82 figure 15 measurement device and its frequency characteristic of the illustrations [see 19.4 e)] 83, figure 16   
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Tile in English:  Medical electrical equipment - Part 1:General requirements for safety

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