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GB 9706.202-2021: Medical electrical equipment -- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
GB 9706.202-2021
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
CCS C 41
Replacing GB/T 9706.4-2009
Medical electrical equipment - Part 2-2.Particular
requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency
surgical accessories
(IEC 60601-2-2.2017, MOD)
ISSUED ON. DECEMBER 01, 2021
IMPLEMENTED ON. MAY 01, 2023
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3 
Introduction... 7 
201.1 Scope, object and related standards... 9 
201.2 Normative references... 11 
201.3 Terms and definitions... 11 
201.4 General requirements... 18 
201.5 General requirements for testing of ME EQUIPMENT... 19 
201.6 Classification of ME EQUIPMENT and ME SYSTEMS... 20 
201.7 ME EQUIPMENT identification, marking and documents... 20 
201.8 Protection against electrical HAZARDS from ME EQUIPMENT... 27 
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME
SYSTEMS... 47 
201.10 Protection against unwanted and excessive radiation HAZARDS... 47 
201.11 Protection against excessive temperatures and other HAZARDS... 47 
201.12 Accuracy of controls and instruments and protection against hazardous outputs
... 49 
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT... 56 
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)... 57 
201.15 Construction of ME EQUIPMENT... 57 
201.16 ME SYSTEMS... 63 
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS... 63 
202 * ELECTROMAGNETIC DISTURBANCES - Requirements and tests... 63 
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems... 64 
Annexes... 65 
Annex AA (informative) Particular guidance and rationale... 66 
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF
SURGICAL EQUIPMENT... 99 
Bibliography... 109 
Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020
"Standardization Work Guidelines Part 1.Structure and Drafting Rules for
Standardization Documents".
This document is Part 2-2 of GB 9706 “Medical electrical equipment”. GB 9706 has
released the following parts.
- Part 1.General requirements for safety;
- Part 1-3.General requirements for basic safety and essential performance -
Collateral Standard. Radiation protection in diagnostic X-ray equipment;
- Part 2-1.Particular requirements for the basic safety and essential performance of
electron accelerators in the range 1 MeV to 50 MeV;
- Part 2-2.Particular requirements for the basic safety and essential performance of
high frequency surgical equipment and high frequency surgical accessories;
- Part 2-3.Particular requirements for the basic safety and essential performance of
short-wave therapy equipment;
- Part 2-5.Particular requirements for the basic safety and essential performance 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 the 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 the basic safety and essential performance of
an anaesthetic workstation;
- Part 2-16.Particular requirements for the basic safety and essential performance 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 2-24.Particular requirements for the basic safety and essential performance 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
electroencephalographs;
- 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 2-36.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 basic safety and essential performance 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 basic safety and essential performance of
mammographie X-ray equipment and mammographie 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.
This document replaces GB 9706.4-2009 “Medical electrical equipment - Part 2-2.
Particular requirements for the safety of high frequency surgical equipment”. Compared
with GB 9706.4-2009, except for structural adjustment and editorial changes, the main
technical changes are as follows.
- ADD the related content of high current mode (see 201.3.219, 201.12.4.101 of this
document);
- AMEND the definition of “high frequency” by adding the upper limit of frequency
(see 201.3.220 of this document, see 2.12.108 of the 2009 edition);
- ADD the relevant content of conditions for application and evaluating risk in the
general requirements (see 201.4 of this document);
- ADD additional information in instructions for use. description of neuromuscular
stimulation, non-continuous activation, accessories and the maximum allowable
length of accessories and cords (see 201.7.9.2.2.101);
- AMEND the limit for high frequency leakage current of active accessories (see
201.8.8.3.102 of this document, see 59.103.5 of the 2009 edition);
- ADD the requirement for high frequency leakage capacitance in active accessories
insulation (see 201.8.8.3.102);
- AMEND the limit for high frequency leakage current of neutral electrode cord
insulation (see 201.15.101.4 of this document, see 59.104.4 of the 2009 edition);
ADD the requirement for high frequency leakage capacita...