GB 9706.1-2020 English PDF (GB9706.1-2020)

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GB 9706.1-2020: Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
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 conce...