Detail of GB 9706.1-2007

Introduction of GB 9706.1-2007

1* Scope and Object 1.1 Scope This standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15). Although this standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety. SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this standard are not considered. Annexes in this standard are not mandatory unless made so by an explicit statement in the main text. 1.2 Object The object of this standard is to specify general requirements for the safety of MEDICAL ELECTRICAL EQUIPMENT and to serve as the basis for the safety requirements of Particular Standards *1.3 Particular standards A requirement of a Particular Standard takes priority over the corresponding requirement of this General Standard. 1.4 Environmental conditions See Section Two. 1.5 Collateral standards Among series standards for MEDICAL ELECTRICAL EQUIPMENT, general requirements for safety specified in collateral standards shall apply to: ——A set of MEDICAL ELECTRICAL EQUIPMENT (e.g.: irradiation EQUIPMENT); ——A certain characteristic (e.g. electromagnetic compatibility) of all MEDICAL ELECTRICAL EQUIPMENT not sufficiently indicated in general safety standards. If a certain collateral standard is applicable to a certain particular standard, the latter is preferred. 2 Terminology and Definitions For the purpose of this standard, the following shall apply: ——Where the terms "voltage" and "current"' are used, they mean the r.m.s. values of an alternating direct or composite voltage or current. ——The auxiliary verb "shall" means that compliance with a requirement or a test is mandatory for compliance with this standard. "should" means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard. "may" is used to describe a permissible way to achieve compliance with a requirement or test. 2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES 2.1.1 access cover Part of an ENCLOSURE or guard providing the possibility of access to EQUIPMENT parts for the purpose of adjustment, inspection, replacement or repair. 2.1.2 accessible metal part Metal part of EQUIPMENT which can be touched without the use of a TOOL. See also Sub-clause 2.1.22. 2.1.3 accessory Optional component necessary and/or suitable to be used with EQUIPMENT in order to enable, facilitate or improve the intended use of EQUIPMENT or to integrate additional functions. 2.1.4 accompanying documents Documents accompanying EQUIPMENT or an ACCESSORY and containing all important information for USER, OPERATOR, installer or assembler of EQUIPMENT, particularly regarding safety. 2.1.5* applied part A part of EQUIPMENT in NORMAL USE: ——Part of EQUIPMENT which contacts the PATIENT body for need of realizing its function; or ——Part which may contact the PATIENT; or ——Part need to be touched by PATIENT. 2.1.6 enclosure Exterior surface of EQUIPMENT including: ——all ACCESSIBLE METAL PARTS, knobs, grips and the like; ——accessible shafts; ——for the purpose of tests, metal foil, with specified dimensions, applied in contact with parts of the exterior surface made of material with low conductivity or made of insulating material. 2.1.7 F-type isolated (floating) applied part (hereinafter referred to as F-TYPE APPLIED PART) APPLIED PART isolated from all other parts of the EQUIPMENT to such an insulation degree that the PATIENT LEAKAGE CURRENT allowable in SINGLE FAULT CONDITION is not exceeded when external unintended voltage is connected to PATIENT and therefore applied to between the APPLIED PART and earth. F-TYPE APPLIED PART is either TYPE BF APPLIED PART or TYPE CF APPLIED PART. 2.1.8 Not used. 2.1.9 internal electrical power source Power source intended to provide the electrical power necessary to operate EQUIPMENT and which is incorporated in that EQUIPMENT. 2.1.10 live State of a part which, when connection is made to that part, can cause a current exceeding the allowable LEAKAGE CURRENT (specified in Sub-clause 19.3) for the part concerned to flow from that part to earth or from that part to an ACCESSIBLE PART of the same EQUIPMENT. 2.1.11 Not used. 2.1.12 mains part Entirety of all parts of EQUIPMENT intended to have a CONDUCTIVE CONNECTION with the SUPPLY MAINS. For the purpose of this definition, the PROTECTIVE EARTH CONDUCTOR is not regarded as a part of the MAINS PART (see Figure 1). 2.1.13 Not used. 2.1.14 Not used. 2.1.15* patient circuit Any circuit containing one or more PATIENT CONNECTION(S). PATIENT CIRCUIT includes conductive components with insulation failing to reach dielectric strength requirements (see Chapter 20),or with isolation failing to reach CREEP DISTANCE and ELECTRICAL CLEARANCE requirements (see Sub-clause 57.10), where under PATIENT CONNECTION.

Contents of GB 9706.1-2007

ontents Foreword i SECTION ONE GENERAL 1* Scope and Object 2 Terminology and Definitions 3 General Requirements 4* General Requirements for Tests 5* Classification 6 Identification, Marking and Documents 7 Power Input SECTION TWO ENVIRONMENTAL CONDITIONS 8 Basic Safety Categories 9 Removable Protective Means 10 Environmental Conditions 11 No General Requirements 12 No General Requirements SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 13 General 14 Requirements Related to Classification 15 Limitation of Voltage and/or Energy 16* ENCLOSURES and PROTECTIVE COVERS 17* Separation (Previous Title: Insulation and Protective Impedances) 18 Protective Earthing, Functional Earthing and Potential Equalization 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 20 Dielectric Strength SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical Strength 22* Moving Parts 23 Surfaces, Corners and Edges 24 Stability in NORMAL USE 25 Expelled Parts 26* Vibration and Noise 27 Pneumatic and Hydraulic Power 28 Suspended Masses SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 29 X-Radiation 30 Alpha, Beta, Gamma, Neutron Radiation and Other Particle Radiation 31 Microwave Radiation 32 Light Radiation (Including Lasers) 33 Infra-red Radiation 34 Ultraviolet Radiation 35 Acoustical Energy (Including Ultra-sonics) 36* Electromagnetic Compatibility SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES 37 Locations and Basic Requirements 38 Marking, ACCOMPANYING DOCUMENTS 39 Common Requirements for CATEGORY AP and CATEGORY APG EQUIPMENT 40. Requirements and Tests for CATEGORY AP EQUIPMENT, Parts and Components thereof 41. Requirements and Tests for CATEGORY APG EQUIPMENT, Parts and Components thereof SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS 42. Excessive Temperatures 43. Fire Prevention 44. Overflow, Spillage, Leakage, Humidity, Ingress of Liquids, Cleaning, Sterilization and Disinfection 45.* Pressure Vessels and Parts subject to PRESSURE 46.* Human Errors 47. Electrostatic Charges 48 Biocompatibility 49.* Interruption of the Power Supply SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50. Accuracy of Operating Data 51. Protection against Hazardous Output SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS 52. Abnormal Operation and Fault Conditions 53. ENVIRONMENTAL TESTS SECTION TEN CONSTRUCTIONAL REQUIREMENTS 54.* General 55. ENCLOSURES and Covers 56. Components and General Assembly 57. MAINS PARTS, COMPONENTS AND LAYOUT 58 Protective Earthing - Terminals and Connections 59 Construction and Layout Annex A (Informative) General Guidance and Rationale Annex B (Informative) Testing during Manufacture and/or Installation Annex C (Informative) Sequence of Testing Annex D (Normative) Symbols on Marking Annex E (Informative) Survey of Insulation Paths and Test Circuits Annex F (Informative) Test Apparatus for Flammable Mixtures Annex G (Normative) Impact-Test Apparatus Annex H (Informative) Screwed Terminal Connections Annex J (Informative) Mains Supply Transformers Annex K (Normative) Examples of the Connection of the Applied Part for Measurement of the Patient Leakage Current (See Chapter 19) Annex L (Normative) Normative References Table 1 Specified Atmospheric Conditions Table 2 Marking on the Outside of EQUIPMENT Table 3 Recommended Colors of Indicator Lights and Their Meaning for EQUIPMENT Table 4 Allowable Values of Continuous LEAKAGE and PATIENT AUXILIARY CURRENTS* Table 5 Test Voltages Table 8 Drop Height Table 9 Gas-tightness of Cord Inlets Table 10a) Allowable Maximum Temperatures1) Table 10b) Allowable Maximum Temperatures1) Table 11 Maximum Temperatures under Fault Conditions Table 12 Temperature Limits of Motor Windings, in℃ Table 13 Test Torques for Rotating Controls Table 15 NOMINAL CROSS-SECTIONAL AREA of POWER SUPPLY CORDS Table 18 Testing of Cord Anchorages Table 19 Maximum Allowable Temperatures at 25℃ Ambient Temperature of Mains Supply Transformer Windings under Overload and Short-circuit Conditions Table 20 Test Current for Mains Supply Transformers Table161) CREEPAGE DISTANCES and AIR CLEARANCES Figure 1 Example of the Defined Terminals and Conductors (see Chapter 2) Figure 2 Example of a Class I EQUIPMENT (see Sub-clause 2.2.4) Figure 3 Example of A Metal-enclosed Class II EQUIPMENT (See Sub-clause 2.2.5) Figure 4 No General Requirements Figure 5 Detachable Mains Connection (See Chapter 2) Figure 6 No General Requirements Figure 7 Standard Test Finger (See Chapter 16) Figure 8 Test Pin (See Chapter 16) Figure 9 Test Hook (See Chapter 16) Figure 10 Measuring Supply Circuit with One Side of the SUPPLY MAINS at (Approximately) Earth Voltage [See Sub-clause 19.4b)] Figure 11 Measuring Supply Circuit with the SUPPLY MAINS Approximately Symmetrical to Earth [See Sub-clause 19.4b)] Figure 12 Measuring Supply Circuit for Poly-phase EQUIPMENT Specified for Connection to A Poly-phase SUPPLY MAINS [See Sub-clause 19.4b)] Figure 13 Measuring Supply Circuit for Single-phase EQUIPMENT Specified for Connection to A Poly-phase SUPPLY MAINS [See Sub-clause19.4b)] Figure 14 Measuring Supply Circuit for Either EQUIPMENT Supplied from A Specified Class I Single-phase Power Supply or for EQUIPMENT Supplied from A Specified Class II Single-phase Power Supply Figure 15 Example of A Measuring Device and Its Frequency Characteristic [See Sub-clause 19.4e)] Figure 16 Measuring Circuit for the EARTH LEAKAGE CURRENT of Class I EQUIPMENT, with or without APPLIED PART [See Sub-clause 19.4 f) and Notes to Table 4] Figure 17 Measuring Circuit for the EARTH LEAKAGE CURRENT of EQUIPMENT, with or without APPLIED PART, Specified for Use with A Specified Class I Single-phase Power Supply [See Sub-clause 19.4 f) and Notes of Table 4] Figure 18 Measuring Circuit for the ENCLOSURE LEAKAGE CURRENT Figure 19 Measuring Circuit for the ENCLOSURE LEAKAGE CURRENT of EQUIPMENT with or without APPLIED PART, Intended Only for Use with A Specified Single-phase Power Supply Figure 20 Measuring Circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to Earth Figure 21 Measuring Circuit for the PATIENT LEAKAGE CURRENT via an F-TYPE APPLIED PART to Earth Caused by An External Voltage on the APPLIED PART Figure 22 Measuring Circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to Earth Caused by An External Voltage on a SIGNAL INPUT or a SIGNAL OUTPUT PART Figure 23 Measuring Circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to the ENCLOSURE of INTERNALLY POWERED EQUIPMENT [See Sub-clause 19.4h)] Figure 24 Measuring Circuit for the PATIENT LEAKAGE CURRENT Via an F-TYPE APPLIED PART to the ENCLOSURE of INTERNALLY POWERED EQUIPMENT [See Sub-clause 19.4h)] Figure 25 Measuring Circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to Earth of INTERNALLY POWERED EQUIPMENT, Caused by An External Voltage on a SIGNAL INPUT or SIGNAL OUTPUT PART [See Sub-clause 19.4h)] Figure 26 Measuring Circuit for the PATIENT AUXILIARY CURRENT Figure 27 Measuring Circuit for the PATIENT AUXILIARY CURRENT of INTERNALLY POWERED EQUIPMENT ([See Sub-clause 19.4j)] Figure 28 Example of A Circuit for Dielectric Strength Test at Operating Temperature for Heating Elements (See Sub-clause 20.4) Figure 29 Maximum Allowable Current IzR as A Function of the Maximum Allowable Voltage UzR Measured in A Purely Resistive Circuit with the Most Readily Flammable Mixture of Ether Vapor with Air (See Sub-clause 40.3) Figure 30 Maximum Allowable Voltage UZC as A Function of the Capacitance Cmax Measured in A Capacitive Circuit with the Most Readily Flammable Mixture of Ether Vapor with Air (See Sub-clause 40.3) Figure 31 Maximum Allowable Current IZL as A Function of the Inductance Lmax, Measured in An Inductive Circuit with the Most Readily Flammable Mixture of Ether Vapor with Air (See Sub-clause 40.3) Figure 32 Maximum Allowable Current IZR as A Function of the Maximum Allowable Voltage UZR, Measured in A Purely Resistive Circuit with the Most Readily Flammable Mixture of Ether Vapor with Oxygen (See Sub-clause 41.3) Figure 33 Maximum Allowable Voltage UZC as A Function of the Capacity Cmax, Measured in A Capacitive Circuit with the Most Readily Flammable Mixture of Ether Vapor with Oxygen (See Sub-clause 41.3) Figure 34 Maximum Allowable Current Izl as A Function of the Inductance Lmax, Measured in An Inductive Circuit with the Most Readily Flammable Mixture of Ether Vapor with Oxygen (See Sub-clause 41.3) Figure 35 No General Requirements Figure 36 No General Requirements Figure 37 No General Requirements Figure 38 Ratio between HYDRAULIC TEST PRESSURE and MAXIMUM PERMISSIBLE WORKING PRESSURE (see Sub-clause 45.2) Figure 39 Example 1 (See Sub-clause 57.10) Figure 40 Example 2 (See Sub-clause 57.10) Figure 41 Example 3 (See Sub-clause 57.10) Figure 42 Example 4 (See Sub-clause 57.10) Figure 43 Example 5 (See Sub-clause 57.10) Figure 44 Example 6 (See Sub-clause 57.10) Figure 45 Example 7 (see Sub-clause 57.10) Figure 46 Example 8 (See Sub-clause 57.10) Figure 47 Example 9 (See Sub-clause 57.10) Figure 48 Ball-pressure Test Apparatus [See Sub-clause 59.2] Figure 49 No General Requirements Figure 50 Test Voltage Applied to Patient Connection Bridged by Defibrillation-proof APPLIED PART (See 17h) Figure 51 Test Voltage Applied to Single Patient Connection Bridged by Defibrillation-proof Applied Part (See 17h)