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GB 9706.1-2020 English PDF (GB 9706.1-2007, GB 9706.1-1995)

GB 9706.1-2020_English: PDF (GB9706.1-2020)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
GB 9706.1-2020English1705 Add to Cart 0--9 seconds. Auto-delivery Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance Valid GB 9706.1-2020
GB 9706.1-2007English685 Add to Cart 0--9 seconds. Auto-delivery Medical electrical equipment -- Part 1: General requirements for safety Obsolete GB 9706.1-2007
GB 9706.1-1995EnglishRFQ ASK 10 days [Need to translate] Medical electrical equipment--Part 1: General requirements for safety Obsolete GB 9706.1-1995
GB 9706.1-1988EnglishRFQ ASK 3 days [Need to translate] Medical electrical equipment--Part 1: General requirements for safety Obsolete GB 9706.1-1988


BASIC DATA
Standard ID GB 9706.1-2020 (GB9706.1-2020)
Description (Translated English) Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
Sector / Industry National Standard
Classification of Chinese Standard C30
Classification of International Standard 11.040
Word Count Estimation 304,314
Date of Issue 2020-04-09
Date of Implementation 2023-05-01
Drafting Organization Shanghai Medical Device Inspection Institute, Beijing Medical Device Inspection Institute, Liaoning Provincial Medical Device Inspection Institute, Zhejiang Medical Device Inspection Institute, Shenzhen Mindray Biomedical Electronics Co., Ltd., GE Medical Systems Trade Development (Shanghai) Co., Ltd., Shanghai Siemens Medical Devices Co., Ltd., Philips Medical (Suzhou) Co., Ltd.
Administrative Organization State Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Administration for Market Regulation, National Standardization Administration

BASIC DATA
Standard ID GB 9706.1-2007 (GB9706.1-2007)
Description (Translated English) Medical electrical equipment -- Part 1: General requirements for safety
Sector / Industry National Standard
Classification of Chinese Standard C30
Classification of International Standard 11.040
Word Count Estimation 146,171
Date of Issue 2007-07-02
Date of Implementation 2008-07-01
Older Standard (superseded by this standard) GB 9706.1-1995
Adopted Standard IEC 60601-1-1988, IDT
Drafting Organization Shanghai Medical Device Testing
Administrative Organization National Standardization Technical Committee of Medical electrical
Regulation (derived from) China Announcement of Newly Approved National Standards No. 8, 2007 (No. 108 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China
Summary This Chinese standard applies to medical electrical equipment (see Definition 2. 2. 15) security. Although this standard is mainly related to security issues, but it also includes some security-related requirements for reliable operation. Equipment covered by this standard are expected physiological effects caused by the security aspects were not considered dangerous. Unless expressly stated in the body of the standard, the standard in the appendix does not require enforcement.

BASIC DATA
Standard ID GB 9706.1-1995 (GB9706.1-1995)
Description (Translated English) Medical electrical equipment--Part 1: General requirements for safety
Sector / Industry National Standard
Classification of Chinese Standard C37
Classification of International Standard 11.14
Word Count Estimation 135,115
Date of Issue 1995/12/21
Date of Implementation 1996/12/1
Older Standard (superseded by this standard) GB 9706.1-1988
Adopted Standard IEC 60601-1-1988, IDT; IEC 60601-1 AMD.1-1991, IDT
Regulation (derived from) China Announcement of Newly Approved National Standards 2007 No. 8 (No. 108 overall)
Proposing organization National Medical Electrical Apparatus Standardization Technical Committee
Issuing agency(ies) State Bureau of Technical Supervision
Summary This Standard is applicable to the safety of medical electrical equipment. Although This Standard is applicable to security issues, but it also includes some of the requirements for reliable operation and safety. Safety hazard This Standard is applicable to the equipment caused by the physiological effects are not expected to be considered. In addition to the provisions of this standard expressly specified otherwise, the standard is not required to enforce appendix.


GB 9706.1-2020 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040 C 30 Replacing GB 9706.1-2007, GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2012, MOD) ISSUED ON: APRIL 09, 2020 IMPLEMENTED ON: MAY 01, 2023 Issued by: State Administration for Market Regulation; Standardization Administration of the PRC. Table of Contents Foreword ... 4 1 Scope, object and related standards ... 11 2 Normative references ... 12 3 * Terminology and definitions ... 17 4 General requirements ... 51 5 * General requirements for testing ME EQUIPMENT ... 62 6 * Classification of ME EQUIPMENT and ME SYSTEMS ... 69 7 ME EQUIPMENT identification, marking and documents ... 70 8 * Protection against electrical HAZARDS from ME EQUIPMENT ... 96 9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ... 174 10 * Protection against unwanted and excessive radiation HAZARDS ... 204 11 Protection against excessive temperatures and other HAZARDS ... 207 12 * Accuracy of controls and instruments and protection against hazardous outputs ... 226 13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT 229 14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ... 238 15 Construction of ME EQUIPMENT ... 246 16 * ME SYSTEMS ... 265 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .. 274 Annex A (Informative) General guidance and rationale ... 275 Annex B (Informative) Sequence of testing ... 435 Annex C (Informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS ... 439 Annex D (Informative) Symbols on marking ... 443 Annex E (Informative) Examples of the connection of the measuring device (MD) for measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT (see 8.7) ... 452 Annex F (Informative) Suitable measuring supply circuits ... 454 Annex G (Normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures ... 457 Annex H (Informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentation ... 476 Annex I (Informative) ME SYSTEMS aspects ... 487 Annex J (Informative) Survey of insulation paths (see 8.5.1) ... 493 Annex K (Informative) Simplified PATIENT LEAKAGE CURRENT diagrams ... 496 Annex L (Normative) Insulated winding wires for use without interleaved insulation (8.8.2) ... 499 Annex M (Normative) Reduction of pollution degrees (see 8.9.1.8) ... 503 Bibliography ... 504 Foreword All technical content of this Part is mandatory. GB 9706 "Medical electrical equipment" is divided into the following parts: - Part 1: General requirements for basic safety and essential performance; - Part 1-3: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV; - Part 2-2: Particular requirements for the safety of high frequency surgical equipment; - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment; - Part 2-4: Particular requirements for the safety of cardiac defibrillators; - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment; - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment; - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV; - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment; - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators; - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation; - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment; - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy after-loading equipment; - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment; - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators; - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment; - Part 2-24: Particular requirements for the safety of infusion pumps and controllers; - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs; - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph; - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment; - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis; - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators; - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy; - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment; - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment; - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures; - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography; - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices; - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy; - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment; - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment; - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment; - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems. This Part is Part 1 of GB 9706. This Part is drafted in accordance with the rules given in GB/T 1.1-2009. This Part replaces GB 9706.1-2007 "Medical electrical equipment - Part 1: General requirements for safety" and GB 9706.15-2008 "Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems". This Part is based on GB 9706.1-2007 and integrates all the contents of GB 9706.15-2008. Compared with GB 9706.1-2007, in addition to editorial changes, the main technical changes are as follows: - Incorporate the contents of GB 9706.15 and YY/T 0708 into this Part; - ADD requirements for essential performance (see Clause 4); - ADD the concept of expected service life (see 4.4); - ADD content related to risk management (see 4.2); - ADD different requirements for operator protection and patient protection (see Clause 8); - Modify the test requirements for protection against electric shock (see Clause 8; Clause 3 of the 2007 edition); - ADD relevant requirements for mechanical safety (see Clause 9); - ADD fire prevention requirements (see 11.3). This Part uses the redraft law to modify and adopt IEC 60601-1:2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". The technical differences between this Part and IEC 60601-1:2012 and their reasons are as follows:  Replace IEC 60851-6:1996+AMD1:1997 with GB/T 4074.6-2008 identical to the international standard;  Replace IEC 60447 with GB/T 4205 identical to the international standard;  Replace IEC 60112 with GB/T 4207 identical to the international standard;  Replace IEC 60529:1989+AMD1:1999 with GB/T 4208 identical to the international standard;  Replace IEC 60335-1:2010 with GB 4706.1-2005 identical to the international standard;  Replace IEC 60950-1:2001 with GB 4943.1-2011 which modifies and adopts the international standard;  Replace IEC 60245-1:2003+AMD1:2007 with GB/T 5013.1-2008 identical to the international standard;  Replace IEC 60695-11-10 with GB/T 5169.16 identical to the international standard;  Replace IEC 60417 with GB/T 5465.2 identical to the international standard;  Replace IEC 60086-4 with GB 8897.4 identical to the international standard;  Replace IEC 60065:2001+AMD1:2005+AMD2:2010 with GB 8898- 2011 which modifies and adopts the international standard;  Replace IEC 60127-1 with GB/T 9364.1 which modifies and adopts the international standard;  Replace IEC 60601-1-3 with GB 9706.12 identical to the international standard;  Replace IEC 60085 with GB/T 11021 identical to the international standard;  Replace ISO 2878 with GB/T 11210 identical to the international standard;  Replace ISO 5349-1 with GB/T 14790.1 identical to the international standard; Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 1 Scope, object and related standards 1.1 * Scope This Part of GB 9706 specifies the GENERAL REQUIREMENTS for BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS. This Part applies to MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this Part are not covered by specific requirements in this Part except in 7.2.13 and 8.4.1. Note 1: See also 4.2. The 9706 series does not apply to: - in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61]; - implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or - medical gas pipeline systems covered by ISO 7396-1 [68]. Note 2: ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS. Note 3: An asterisk (*) is used as the first character of the title or the beginning of a paragraph or table title, indicating that there are guidelines and rationale related to immersion “o” (GB/T 3836.6-2017, IEC 60079-6:2015, MOD) GB/T 3836.7 Explosive atmospheres - Part 7: Equipment protection by powder filling “q” (GB/T 3836.7-2017, IEC 60079-5:2015, MOD) GB/T 4026 Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors (GB/T 4026-2019, IEC 60445:2017, IDT) GB/T 4074.6-2008 Winding wires - Test methods - Part 6: Thermal properties (IEC 60851-6:1996, IDT) GB/T 4205 Basic and safety principles for man-machine interface (MMI), marking and identification - Actuating principles (GB/T 4205-2010, IEC 60447:2004, IDT) GB/T 4207 Method for the determination of the proof and the comparative tracking indices of solid insulating materials (GB/T 4207-2012, IEC 60112:2009, IDT) GB/T 4208 Degrees of protection provided by enclosure (IP code) (GB/T 4208-2017, IEC 60529:2013, IDT) GB 4706.1-2005 Household and similar electrical appliances - Safety - Part 1: General requirements [IEC 60335-1:2004 (Ed4.1), IDT] GB 4943.1-2011 Information technology equipment - Safety - Part 1: General requirements (IEC 60950-1:2005, MOD) GB/T 5013.1-2008 Rubber insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements (IEC 60245-1:2003, IDT) GB/T 5023.1-2008 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements (IEC 60227-1:2007, IDT) GB/T 5169.16 Fire hazard testing for electric and electronic products - Part 16: Test flames - 50 W horizontal and vertical flame test methods (GB/T 5169.16-2017, IEC 60695-11-10:2013, IDT) GB/T 5465.2 Graphical symbols for use on electrical equipment - Part 2: Graphical symbols (GB/T 5465.2-2008, IEC 60417:2007, IDT) GB/T 6346.14-2015 Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains (IEC 60384- 14:2005, IDT) GB 7247.1-2012 Safety of laser products - Part 1: Equipment classification and requirements (IEC 60825-1:2007, IDT) GB 8897.4 Primary batteries - Part 4: Safety of lithium batteries (GB 8897.4- 2008, IEC 60086-4:2007, IDT) GB 8898-2011 Audio, video and similar electronic apparatus - Safety requirements (IEC 60065:2005, MOD) GB/T 9364.1 Miniature fuses - Part 1: Definitions for miniature fuses and general requirement for miniature fuse-links (GB/T 9364.1-2015, IEC 60127- 1:2006, MOD) GB 9706.12 Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (GB 9706.12-1997, idt IEC 60601-1-3:1994) GB/T 11021 Electrical insulation - Thermal evaluation and designation (GB/T 11021-2014, IEC 60085:2007, IDT) GB/T 11210 Rubber, vulcanized or thermoplastic - Antistatic and conductive products - Determination of electrical resistance (GB/T 11210-2014, ISO 2878:2011, IDT) GB/T 11918.1 Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements (GB/T 11918.1-2014, IEC 60309-1:2012, MOD) GB/T 11918.2 Plugs, socket-outlets and couplers for industrial purposes - Part 2: Dimensional compatibility and interchangeability requirements for pin and contact-tube accessories (GB/T 11918.2-2014, IEC 60309-2:2012, MOD) GB/T 14790.1 Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 1: General requirements (GB/T 14790.1-2009, ISO 5349-1:2001, IDT) GB/T 15092.1 Switches for appliances - Part 1: General requirements (GB/T 15092.1-2010, IEC 61058-1:2008, IDT) GB/T 16886 (all parts) Biological evaluation of medical devices [ISO 10993 (all parts)] GB/T 16895.21 Low-voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock (GB/T 16895.21-2011, IEC 60364- 4-41:2005, IDT) GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage systems - Part 1: Principles requirements and tests (IEC 60664-1:2007, IDT) GB/T 17465.1 Appliances couplers for household and similar general purposes - Part 1: General requirements (GB/T 17465.1-2009, IEC 60320- 1:2007, MOD) GB 18278.1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18278.1-2015, ISO 17665- 1:2006, IDT) GB 18279.1-2015 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007, IDT) GB 18280.1-2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, IDT) GB/T 19212.2 Safety of power transformers, power supplies, reactors and similar products - Part 2: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications (GB/T 19212.2-2012, IEC 61558-2-1:2007, IDT) GB/T 23821-2009 Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857:2008, IDT) GB 27701 Mechanical safety of cathode ray tubes (GB 27701-2011, IEC 61965:2003, IDT) GB/T 28164 Secondary cells and batteries containing alkaline or other non- acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable application (GB/T 28164-2011, IEC 62133:2002, IDT) YY/T 0316-2016 Medical devices - Application of risk management to medical devices (ISO 14971:2007, IDT) YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT) YY 0505 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (YY 0505-2012, IEC 60601-1-2:2004, IDT) YY/T 0664-2008 Medical device software - Software life cycle processes (IEC 62304:2006, IDT) YY 0709 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (YY 0709-2009, IEC 60601-1-8:2003, IDT) ISO 2882 Rubber, vulcanized - Antistatic and conductive products for hospital use - Electrical resistance limits ISO 3864-1:2002 Graphical symbols - Safety colours and safety signs - Part 1: Design principles for safety signs in workplaces and public areas ISO 7000:2004 Graphical symbols for use on equipment - Index and synopsis ISO 7010:2011 Graphical symbols - Safety colours and safety signs - Registered safety signs ISO 9614-1 Determination of sound power levels of noise sources using sound intensity - Measurement at discrete points ISO 80000-1:2009 Quantities and units - Part 1: General IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability IEC 60730-1:2010 Automatic electrical controls - Part 1: General requirements IEC 60851-3:2009 Winding wires - Test methods - Part 3: Mechanical properties IEC 60851-5:2008 Winding wires - Test methods - Part 5: Electrical properties 3 * Terminology and definitions For the purposes of this document, the following terms and definitions apply. Note 1: Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. values of an alternating, direct or composite voltage or current unless stated otherwise. Note 2: The term “electrical equipment” is used to mean ME EQUIPMENT (see 3.63) or other electrical equipment. This Part also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM (see 3.64). ......


GB 9706.1-2007 Medical electrical equipment.Part 1. General requirements for safety ICS 11.040 C30 National Standards of People's Republic of China Replace GB 9706.1-1995 Medical electrical equipment Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) Released on.2007-07-02 2008-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Administration issued Content Foreword V The first overview 1 1 Scope and purpose 1 2 Terms and Definitions 1 3 General requirements 13 4 General requirements for testing 14 5 Category 16 6 Identification, marking and documentation 16 7 input power 23 The second environmental condition 24 8 basic safety type 24 9 detachable protection device 24 10 Environmental conditions 24 11 No general requirements 25 12 No general requirements 25 The third protection against electric shock hazard 25 13 Overview 25 14 Requirements for classification 25 15 Voltage and/or energy limits 26 16 Housing and protective cover 26 17 Isolation (former title. Insulation and Protection Impedance) 28 18 Protective earthing, functional grounding and potential equalization 30 19 continuous leakage current and patient auxiliary current 31 20 dielectric strength 37 The fourth protection against mechanical hazards 40 21 Mechanical strength 40 22 moving parts 42 23 faces, corners and sides 42 24 Stability during normal use 42 25 Splash 43 26 Vibration and noise 43 27 Pneumatic and hydraulic power 43 28 hanging objects 43 Section 5 Protection against unwanted or excessive radiation hazards 44 29 X-ray radiation 44 30 α, β, γ, neutron radiation and other particle radiation 44 31 microwave radiation 45 32 optical radiation (including laser) 45 GB 9706.1-2007/IEC 60601-1.1988 33 infrared radiation 45 34 UV radiation 45 35 Acoustic energy (including ultrasound) 45 36 Electromagnetic compatibility 45 Chapter VI Protection against ignition hazard of flammable anesthesia mixtures 45 37 Location and basic requirements 45 38 marks, random files 46 39 Common requirements for AP and APG equipment 46 40 Requirements and tests for AP-type equipment and its components and components 47 41 Requirements and tests for APG-type equipment and its components and components 49 Section VII Protection against over-temperature and other safety hazards 50 42 over temperature 50 43 fire prevention 54 44 Overflow, liquid spillage, leakage, moisture, fluid, cleaning, disinfection, sterilization and compatibility 54 45 Pressure vessel and pressure component 55 46 Human error 56 47 static charge 56 48 Biocompatibility 56 49 Power supply interruption 56 The accuracy of the eighth work data and the prevention of dangerous output 57 50 Accuracy of work data 57 51 Prevention of dangerous output 57 The ninth abnormal operation and fault state; environmental test 57 52 abnormal operation and fault status 57 53 Environmental Test 61 Chapter 10 Structural Requirements 61 54 Overview 61 55 housing and cover 61 56 Components and Components 62 57 network power supply parts, components and wiring 66 58 Protective Earthing - Terminals and Connections 74 59 Structure and wiring 74 Appendix A (informative) General guidelines and preparation instructions 101 Appendix B (informative) Tests during manufacturing and/or installation 124 Appendix C (informative) Test sequence 124 Appendix D (normative appendix) Marking symbol 127 Appendix E (informative) Inspection and test circuit for insulation paths 129 Appendix F (informative) Test device for flammable mixtures 133 Appendix G (Normative Appendix) Impact Test Equipment 134 Appendix H (informative) Threaded terminal block 134 Appendix J (informative) Power Transformer 134 Appendix K (Normative Appendix) Example of applying partial connections when measuring patient leakage current (see Chapter 19) 135 GB 9706.1-2007/IEC 60601-1.1988 Appendix L (Normative Appendix) Normative References 137 The atmospheric conditions specified in Table 1 14 Table 2 Device external marking 17 Table 3 Recommended colors and meanings of device indicators 21 Table 4 Allowable values for continuous leakage current and patient auxiliary current 33 Table 5 Test voltage 39 Table 8 Falling height 41 Table 9 Air tightness at the wire inlet 49 Table 10a) Maximum allowable temperature 50 Table 10b) Maximum allowable temperature 51 Table 11 Maximum temperature in fault condition 58 Table 12 Temperature Limits of Motor Windings 59 Table 13 Test Torque for Rotary Controllers 65 Table 15 Nominal cross-sectional area of power soft wire 67 Table 18 Tests for parts used for fixing flexible wires 68 Table 19 Maximum allowable temperature of the network power transformer winding overload and short circuit condition when the ambient temperature is 25 °C Table 20 Power transformer test current 71 Table 16 Creepage distance and clearance 74 Figure 1 shows the illustration of the terminals and wires (see Chapter 2) 77 Figure 2 Legend of a Class I device (see 2.2.4) 78 Figure 3 Legend of a Class II device with a metal casing (see 2.2.5) 78 Figure 4 No general requirements 79 Figure 5 Removable network power connection (see Chapter 2) 79 Figure 6 No general requirements 79 Figure 7 Standard test finger (see Chapter 16) 80 Figure 8 Test needle (see Chapter 16) 80 Figure 9 Test hook (see Chapter 16) 81 Figure 10 Measurement of the power supply circuit at one end of the power supply network at approximately ground potential [19.4b)] 81 Figure 11 Measurement of the power supply network when the ground potential is approximately symmetrical [19.4b)] 81 Figure 12 shows the measurement supply circuit for multiphase devices connected to a multiphase supply network [19.4b)] 82 Figure 13 shows the measurement supply circuit for a single-phase device connected to a multiphase supply network [19.4b)] 82 Figure 14 is a measurement power supply circuit 82 for a device that is specified to be powered by a Class I or Class II single phase power supply. Figure 15 Legend of the measuring device and its frequency characteristics [see 19.4e)] 83 Figure 16 Measurement circuit for ground leakage current of Class I equipment with or without application part [19.4f) and Note of Table 4] 84 Figure 17 Measurement circuit for ground leakage current using a specified Class I single-phase power supply, with or without an application part [19.4f) 4 note] 84 Figure 18 Measuring circuit for leakage current of the casing 85 Figure 19 Measurement circuit 86 for leakage current of the device housing with or without the application portion of the specified single-phase power supply Figure 20 Measurement circuit 87 for patient leakage current from the application part to the ground Figure 21 Measurement circuit 88 for patient leakage current from the F-type application portion to the ground caused by the external voltage on the application portion Figure 22 Measurement of leakage current from the application part to the ground caused by the external voltage on the signal input part or signal output part GB 9706.1-2007/IEC 60601-1.1988 Circuit 89 Figure 23 Measurement circuit for patient leakage current from the application part to the housing of the internal power supply device [see 19.4h)] 89 Figure 24 Measurement circuit for patient leakage current from the F-type application section to the enclosure of the internal power supply equipment [see 19.4h)] 90 Figure 25 Internal power supply device, from the application part to the ground caused by the external voltage on the signal input part or signal output part Measurement circuit for leakage current [see 19.4h)] 90 Figure 26 Patient Auxiliary Current Measurement Circuit 91 Figure 27 Measurement circuit for patient auxiliary current in internal power supply equipment [see 19.4j)] 91 Figure 28 Diagram of the dielectric strength test circuit for the heating element at operating temperature (see 20.4) 92 Figure 29 Maximum allowable current IzR and maximum capacitance measured on a purely ohmic circuit in the most flammable gas mixture of ether vapor and air The functional relationship of the voltage UzR (see 40.3) 92 Figure 30 Maximum allowable voltage UzC and capacitance measured on a capacitor circuit in the most flammable gas mixture of ether vapor and air Functional relationship of Cmax (see 40.3) 93 Figure 31 Maximum allowable current IzL and inductance measured on the inductive circuit in the most flammable gas mixture of ether vapor and air The functional relationship of Lmax (see 40.3) 93 Figure 32. Maximum allowable current IzR and maximum allowable capacitance measured on a purely ohmic circuit in the most flammable gas mixture of ether vapor and oxygen. Functional relationship of voltage UzR (see 41.3) 94 Figure 33 Maximum allowable voltage UzC and capacitance measured on a capacitor circuit in the most flammable gas mixture of ether vapor and oxygen Functional relationship of Cmax (see 41.3) 94 Figure 34 The maximum allowable current IzL and inductance Lmax measured on the inductive circuit in the most flammable gas mixture of ether vapor and oxygen. Functional relationship (see 41.3) 95 Figure 35 No general requirements 95 Figure 36 No general requirements 95 Figure 37 No general requirements 95 Figure 38 Proportion of hydraulic test pressure to maximum allowable working pressure 95 Figure 39 Example 1 (see 57.10) 95 Figure 40 Example 2 (see 57.10) 96 Figure 41 Example 3 (see 57.10) 96 Figure 42 Example 4 (see 57.10) 96 Figure 43 Example 5 (see 57.10) 96 Figure 44 Example 6 (see 57.10) 96 Figure 45 Example 7 (see 57.10) 97 Figure 46 Example 8 (see 57.10) 97 Figure 47 Example 9 (see 57.10) 97 Figure 48 Ball pressure test device (see 59.2) 98 Figure 49 No general requirements 98 Figure 50 Test voltage applied to the patient junction where the anti-defibrillation application is partially bridged [see 17h)] 99 Figure 51 Test voltage applied to a single patient connection in the anti-defibrillation application section [see 17h)] 100 GB 9706.1-2007/IEC 60601-1.1988 Foreword The Safety Series of Medical Electrical Equipment consists of two parts. --- Part 1. General requirements for safety; --- Part 2. Security specific requirements. Part 1 includes a number of side-by-side standards in addition to this safety general requirements standard, which is currently converted to me by the IEC international standard. The national standards are. GB 9706.12-1997 Medical electrical equipment Part 1. General requirements for safety III. Parallel standard. Diagnosing X-ray equipment General requirements for shot protection (idt IEC 60601-1-3.1994); GB 9706.15-1999 Medical electrical equipment Part 1. General requirements for safety 1. Parallel standard. medical electrical system safety Requirements (idt IEC 60601-1-1..1995); YY0505-2005 Medical electrical equipment - Part 1-2. Safety common requirements Parallel standard. Electromagnetic compatibility requirements and testing (IEC 601-1-2.2001, IDT). This part is the first part of GB 9706. This part is equivalent to IEC 60601-1.1988 "Medical Electrical Equipment---Part 1. Safety General Requirements" (English version) and its repair Amendment 1..1991 and Amendment 2..1995. The main differences between this part and IEC 60601-1 are as follows. --- Modified some formatting formats in accordance with GB/T 1.1; --- For other international standards cited in the standard, if it has been converted into Chinese standards, this section replaces the referenced international standard number with The national standard number should be indicated, and the relationship is indicated in Appendix L; --- IEC 60601-1 Amendment 2 of the first natural paragraph of 4.10 and the penultimate natural paragraph of the IPX8 equipment or equipment parts The test requirements are contradictory in the description. Based on the description in Appendix A, the revision is carried out in this revision, ie IPX8 equipment or equipment. The spare parts are not subjected to the moisture pretreatment test; --- Add the proportion of methylated alcohol in Appendix A6.1z) for reference; --- Added a description of the nature of the appendix. This part replaces GB 9706.1-1995 "Medical Electrical Equipment Part 1. General Requirements for Safety". The main changes in this section compared with GB 9706.1-1995 are as follows. --- Add the contents of IEC 60601-1 Modification 2 (1995) to this section. ● The identification of the application part depends on its requirements regarding the possibility of touching the patient's body during normal use, rather than considering it Electrical characteristics; a single patient connection is defined by the requirements associated with electrical contact with the patient during normal use; ● The classification of the degree of protection against electric shock (CF/BF/B type) is no longer related to the word device, but is clearly related to the separate application part. This is more reasonable because the degree of protection is actually determined by the application part; this means there are no additional requirements and tests, but More identification and instructions are required for the required operations; ● Adding general requirements to equipment marked with a defibrillator discharge voltage mark on the application section and without special standards; ● Increased the DC component limit in the patient's leakage current to match the patient's auxiliary current requirements; ● Clarify the level of anti-injection by using the IP code, such as the detailed description of the basic safety standard GB 4208, which is a step; ● Some “not adopted” in GB 9706.1-1995 are replaced by “no general requirements” to avoid misunderstanding. This means that if you think Dedicated standards may specify requirements if necessary; ● The reference standard adds the current parallel standard of GB 9706.1. GB 9706.15, YY0505-2005, GB 9706.12 and IEC 60601-1-4 (see Appendix L); GB 9706.1-2007/IEC 60601-1.1988 ● Added additional requirements for relevant information that must be provided by the manufacturer in order to promote international recognition of symbols and units and provide more Information about the intended use of the equipment; it is required because it is related to performance and safety; ● Certain requirements and test methods are consistent with other existing national or IEC standards; ● In view of some reports, due to the user's incorrect use of biopotential connectors (such as electrodes with wires attached, the other end of the wire is connected) An exposed 2mm metal pin connector) caused an accident, so some additional requirements were introduced to prevent such accidents in any type Reproduce on the device. --- Edited some of the text in GB 9706.1-1995; --- Added Appendix L according to the requirements of GB/T 1.1; --- Increased the content of 57.9.1b) omitted from the GB 9706.1-1995 standard; --- According to the requirements of GB/T 1.1, the preface of the standard has been added; --- According to the requirements of GB/T 1.1, the auxiliary verbs "shal", "should", "may" (may) in the original standard "Yes", "Yes", "Yes"; --- The terminology in Chapter 2 of this part is indicated in bold text in bold text. Appendix D, Appendix G, Appendix K, and Appendix L of this standard are normative appendices, Appendix A, Appendix B, Appendix C, Appendix E, Appendix F, and Appendix Record H, Appendix J is an informative appendix. This part is proposed by the State Food and Drug Administration. This part is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee. This section drafted by. Shanghai Medical Device Testing Institute. The main drafters of this section. Yu Xiping, He Jun, He Aiqin, Ge Weisen. The previous versions of the standards replaced by this section are. ---GB 9706.1-1988, GB 9706.1-1995. GB 9706.1-2007/IEC 60601-1.1988 Medical electrical equipment Part 1. General requirements for safety First overview 1 Scope and purpose 1.1 Scope of application This standard applies to the safety of medical electrical equipment (as defined in 2.2.15). Although this standard mainly deals with safety issues, it also includes some safety-related requirements for reliable operation. The safety hazards posed by the expected physiological effects of the equipment covered by this standard are not considered. The contents of the appendix in the standard do not require enforcement unless explicitly stated in the standard text. 1.2 Purpose The purpose of this standard is to specify the general safety requirements for medical electrical equipment and as the basis for the safety requirements for medical electrical equipment. For a description of the terms of the article, see Appendix A General Guidelines and Compilation Instructions. 1.3 Special standard Dedicated standards take precedence over this general standard. 1.4 Environmental conditions See the second article. 1.5 Parallel standards In the series of medical electrical equipment standards, the parallel standard stipulates that the general safety requirements should apply to. ---A group of medical electrical equipment (eg radiological equipment); --- A characteristic of all medical electrical equipment (eg electromagnetic compatibility) not fully stated in the general safety standards. If a side-by-side standard applies to a specific standard, the special standard takes precedence over this side-by-side standard. 2 Terms and definitions The following terms and definitions in this standard apply. --- "Voltage" and "Current" refer to the rms value of AC, DC or composite voltage or current. ---Assistive verbs “shall” means a requirement or test that is to be enforced in accordance with this standard. “Yi” is expressed as a requirement or an experiment to be implemented in accordance with the recommendations of this standard, but it is not mandatory. “Can” is used to describe the method allowed to achieve a requirement or a test. 2.1 Equipment parts, accessories and accessories 2.1.1 A component on the outer casing or guard that is used to access certain parts of the equipment for adjustment, inspection, replacement, or repair. of. 2.1.2 The metal part of the device that can be accessed without the use of tools. See 2.1.22. GB 9706.1-2007/IEC 60601-1.1988 2.1.3 To facilitate the intended use of the equipment, or to facilitate the intended use of the equipment, or to improve the intended use of the equipment, or to increase Additional features of the device, necessary and/or optional accessories for use with the device. 2.1.4 The file attached to the device or accessory, the content of which contains all the weight of the user, operator, installer or assembler of the device The information you need, especially the information about safety. 2.1.5 Part of a device that is normally used. --- the part of the device that requires physical contact with the patient in order to achieve its function; or --- may be exposed to the patient's part; or --- The part that needs to be touched by the patient. 2.1.6 The outer surface of the device, including. ---All accessible metal parts, knobs, handles and similar components; ---accessible shaft; --- For the purpose of testing, close to the outer surface of the part made of low conductivity material or insulating material, there is a metal foil of the specified size. 2.1.7 The part of the application that is isolated from the rest of the device, the insulation is reached, when an unexpected voltage from the outside is connected to the patient, and thus When applied between the application part and the ground, the current flowing therethrough does not exceed the allowable value of the patient leakage current in the single fault state. The F-type application part is not the BF-type application part or the CF-type application part. 2.1.8 Not used. 2.1.9 A power source that is included in the device and provides the power necessary to operate the device. 2.1.10 Refers to the state in which a part is located. When connected to this part, there is a current exceeding the allowable leakage current value (specified in 19.3) from Partially flows to or from the portion to other accessible portions of the device. 2.1.11 Not used. 2.1.12 The totality of all components in the equipment that are intended to be electrically connected to the power grid. For the purposes of this definition, the protective earth conductor is not considered to be a grid A part of the source part (see Figure 1). 2.1.13 Not used. GB 9706.1-2007/IEC 60601-1.1988 2.1.14 Not used. 2.1.15 Any circuit that contains one or more patient connections. The patient circuit includes all conductive components connected to the patient that do not meet the dielectric strength requirements (see Chapter 20), or with the patient The isolation of the connection does not meet the requirements for creepage distance and clearance (see 57.10) for conductive parts. 2.1.16 Not used. 2.1.17 A part of the enclosure or guard to prevent accidental contact with potentially hazardous parts. 2.1.18 A part of the device, but not the application part, used to receive the voltage or current of the input signal from other devices, such as display, recording Or for data processing (see Figure 1). 2.1.19 A part of a device, but not an application part, that is used to output a signal voltage or current to other devices, such as display, record, or number According to the treatment (see Figure 1). ......

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