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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 | 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| Word Count Estimation | 146,171 | Date of Issue | 2007-07-02 | Date of Implementation | 2008-07-01 | Older Standard (superseded by this standard) | GB 9706.1-1995 | Adopted Standard | IEC 60601-1-1988, IDT | Drafting Organization | Shanghai Medical Device Testing | Administrative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. | 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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