GB 9706.203-2020 English PDF (GB9706.203-2020)

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GB 9706.203-2020: Medical electrical equipment -- Part 2-3: -- Particular requirements for the basic safety and essential performance of short-wave therapy equipment
GB 9706.203-2020
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 42
Medical electrical equipment – Part 2-3: Particular
requirements for the basic safety and essential performance
of short-wave therapy equipment
(IEC 60601-2-3:2016, MOD)
ISSUED ON: MAY 29, 2020
IMPLEMENTED ON: MAY 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
201.1 Scope, object and related standards ... 6
201.2 Normative References ... 7
201.3 Terms and Definitions ... 8
201.4 General requirements ... 8
201.5 General requirements for testing of ME EQUIPMENT ... 8
201.6 Classification of ME EQUIPMENT and ME SYSTEMS ... 9
201.7 ME EQUIPMENT identification, marking and documents ... 9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ... 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME
SYSTEMS ... 15
201.10 Protection against unwanted and excessive radiation HAZARDS ... 15
201.11 Protection against excessive temperatures and other HAZARDS ... 15
201.12 Accuracy of controls and instruments and protection against hazardous outputs
... 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ... 17
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ... 17
201.15 Construction of ME EQUIPMENT... 17
201.16 ME SYSTEMS ... 17
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ... 17
Annex AA (Informative) Particular Guidance and Rationale ... 18
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;
Medical electrical equipment – Part 2-3: Particular
requirements for the basic safety and essential performance
of short-wave therapy equipment
201.1 Scope, object and related standards
Clause 1 of the GB 9706.1-2020 applies, except as follows:
201.1.1 Scope
Replacement:
This Part of GB 9706 specifies the requirements for the safety of SHORT-WAVE THERAPY
EQUIPMENT, hereafter referred to as ME EQUIPMENT.
The defined LOW POWER EQUIPMENT is exempted from certain requirements of this Part.
NOTE: Some of the more important requirements are annotated in the "Special Guidance and
Explanation" section, see Annex AA. Clauses or subclauses corresponding to annotations in Annex AA
are marked with an asterisk (*).
201.1.2 Object
Replacement:
The object of this Part is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for SHORT-WAVE THERAPY EQUIPMENT as defined in
201.3.206.
201.1.3 Collateral standards
Addition:
This Part refers to those applicable collateral standards that are listed in Clause 2 of GB 9706.1-
2020.
201.1.4 Particular standards
Replacement:
In the particular standards may modify, replace or delete requirements contained in the general