GB 9706.202-2021_English: PDF (GB9706.202-2021)
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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
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GB 9706.202-2021
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| Standard ID | GB 9706.202-2021 (GB9706.202-2021) | | Description (Translated English) | 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 | | Sector / Industry | National Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 69,641 | | Date of Issue | 2021-12-01 | | Date of Implementation | 2023-05-01 | | Older Standard (superseded by this standard) | GB 9706.4-2009 | | Adopted Standard | IEC 60601-2-2-2017, MOD | | Drafting Organization | Shanghai Institute of Medical Device Inspection | | Administrative Organization | National Medical Electrical Standardization Technical Committee | | Regulation (derived from) | National Standard Announcement No. 15 of 2021 | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration |
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 capacitance in neutral electrode
cord insulation (see 201.15.101.4 of this document).
This document uses the redrafting method to amend and adopt IEC 60601-2-2.2017
“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”.
The technical differences between this document and IEC 60601-2-2.2017 and their
reasons are as follows.
- Regarding normative references, this document has made adjustments with
technical differences to adapt to the technical conditions of China. The adjustments
are concentrated in 201.2 “Normative references”, and the specific adjustments are
as follows.
● REPLACE CISPR 11.2015 with GB 4824-2019, which is identical to the
international standard;
● REPLACE IEC 60601-1-2.2014 with YY 9706.102-2021, which is modified
from the international standard;
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
201.1 Scope, object and related standards
Clause 1 of the general standard 1 applies, except as follows.
201.1.1 * Scope
Replacement.
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES.
HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50
W (for example for micro-COAGULATION, or for use in dentistry or ophthalmology)
is exempt from certain of the requirements of this document. These exemptions are
indicated in the relevant requirements.
201.1.2 Object
Replacement.
The object of this document is to establish particular BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements for HF SURGICAL EQUIPMENT and
HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.
201.1.3 Collateral standards
Addition.
This document refers to those applicable collateral standards that are listed in Clause 2
of the general standard and Clause 201.2 of this document.
YY 9706.102 and YY 9706.108 apply as modified in Clauses 202 and 208 respectively.
GB 9706.103, YY/T 9706.110 and YY/T 9706.111 do not apply.
201.1.4 Particular standards
Replacement.
general standard or applicable collateral standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this document.
201.2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
Clause 2 of the general standard applies, except as follows.
Replacement.
YY 9706.102-2021 Medical electrical equipment - Part 1-2.General requirements for
BASIC SAFETY and ESSENTIAL PERFORMANCE - Collateral Standard.
Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2.2007, MOD)
YY 9706.108-2021 Medical electrical equipment - Part 1-8.General requirements for
BASIC SAFETY and ESSENTIAL PERFORMANCE - Collateral Standard. General
requirements, tests and guidance for alarm systems in medical electrical equipment and
medical electrical systems (IEC 60601-1-8.2012, MOD)
Addition.
GB 4824-2019 Industrial, scientific and medical equipment - Radio-frequency
disturbance characteristics - Limits and methods of measurement (CISPR 11.2015, IDT)
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in the general
standard and the following apply.
Replace “NOTE 1” with the following.
NOTE 1.Where the terms “voltage” and “current” are used in this document, they mean the RMS
values of an alternating, direct or composite voltage or current averaged over 1 s unless stated
otherwise.
Addition.
201.3.201
ACTIVE ACCESSORY
HF SURGICAL ACCESSORY intended for manipulation by the OPERATOR to
produce an effect by electrical conduction adjacent to the ACTIVE ELECTRODE at
the intended site on the PATIENT, generally comprising an ACTIVE HANDLE, the
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