GB 9706.218-2021 English PDF (GB9706.218-2021)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get QUOTATION in 1-minute: Click GB 9706.218-2021
Historical versions: GB 9706.218-2021
Preview True-PDF (Reload/Scroll if blank)

GB 9706.218-2021: Medical electrical equipment -- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
GB 9706.218-2021
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
CCS C 40
Replacing GB 9706.19-2000
Medical electrical equipment - Part 2-18: Particular
requirements for the basic safety and essential performance
of endoscopic equipment
(IEC 60601-2-18:2009, MOD)
ISSUED ON: DECEMBER 01, 2021
IMPLEMENTED ON: MAY 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3 
Introduction ... 8 
201.1 Scope, object and related standards ... 10 
201.2 Normative references ... 12 
201.3 Terms and definitions ... 12 
201.4 General requirements ... 16 
201.5 General requirements for testing of ME EQUIPMENT ... 18 
201.6 Classification of ME EQUIPMENT and ME SYSTEMS ... 18 
201.7 ME EQUIPMENT identification, marking and documents ... 19 
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ... 23 
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME
SYSTEMS ... 24 
201.10 Protection against unwanted and excessive radiation HAZARDS ... 27 
201.11 Protection against excessive temperatures and other HAZARDS ... 28 
201.12 Accuracy of controls and instruments and protection against hazardous outputs
... 31 
201.13 HAZARDOUS SITUATIONS and fault conditions ... 32 
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ... 32 
201.15 Construction of ME EQUIPMENT ... 32 
201.16 ME SYSTEMS ... 33 
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ... 33 
202 Electromagnetic compatibility - Requirements and tests ... 33 
Annexes ... 35 
Annex C (informative) Guide to marking and labelling requirements for ME
EQUIPMENT and ME SYSTEMS ... 36 
Annex D (informative) Symbols on marking ... 38 
Annex J (informative) Survey of insulation paths ... 40 
Annex AA (informative) Particular guidance and rationale ... 43 
Annex BB (informative) Clauses of this document addressing Essential Principles of
Safety and Performance of Medical Devices ... 57 
Bibliography ... 59 
Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020
“Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents”.
This document is Part 2-18 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 2-29: 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 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 9706.19-2000 “Medical electrical equipment - Part 2:
Particular requirements for the safety of endoscopic equipment”. Compared with GB
9706.19-2000, except for structural adjustment and editorial changes, the main
technical changes are as follows:
- In the scope, AMEND “Supplement” to “Replacement”; ADD “essential
performance” (see 201.1.1 of this document, 1.1 of the 2000 edition);
- In the object, ADD “essential performance” (see 201.1.2 of this document, 1.2 of
the 2000 edition);
- ADD “Collateral standards” (see 201.1.3 of this document);
- In the particular standards, amend “Supplement” to “Replacement” (see 201.1.4 of
this document, 1.3 of the 2000 edition);
- ADD “Normative references” (see 201.2 of this document);
- In the terms and definitions, ADD “CONFIGURATION FOR ENDOSCOPE
APPLICATION”, “ENERGIZED ENDOSCOPE”, “ENERGIZED
ENDOTHERAPY DEVICE”, “HIGH FREQUENCY”, “INTERFACE
CONDITION”, “NEUTRAL ELECTRODE”, “RATED ACCESSORY
VOLTAGE”; AMEND “ENDOSCOPE ACCESSORIES” to “ENDOTHERAPY
DEVICE” (see 201.3 of this document, Clause 2 of the 2000 edition);
- In the general requirements, AMEND “Energized endotherapy devices”...