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

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

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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”,
“Ultrasonic diagnostic equipment”, “SUPPLY UNITS” and “ADDITIONAL
ESSENTIAL PERFORMANCE requirements”; ADD “ESSENTIAL
PERFORMANCE”, “ME EQUIPMENT or ME SYSTEM PARTS that contact the
PATIENT” and “SINGLE FAULT CONDITION for ME EQUIPMENT” (see
201.4 of this document, Clause 3 of the 2000 edition);
- AMEND “General requirements for testing” to “General requirements for testing of ME EQUIPMENT”; ADD “TYPE TESTS” and “Humidity preconditioning
treatment” (see 201.5 of this document, Clause 4 of the 2000 edition);
- AMEND “Classification” to “Classification of ME EQUIPMENT and ME
SYSTEMS”; ADD “Protection against electric shock” (see 201.6 of this document, Clause 5 of the 2000 edition);
- AMEND “Identification, marking and documents” to “ME EQUIPMENT
identification, marking and documents”; AMEND “Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts” and “ACCOMPANYING
DOCUMENTS”; ADD “Marking of controls and instruments”, “Symbols” (see
201.7 of this document, Clause 6 of the 2000 edition);
- ADD “Classification of APPLIED PARTS”, “Separation of parts”; AMEND
“Insulation”, “CREEPAGE DISTANCES and AIR CLEARANCES” (see 201.8 of
this document);
- AMEND “HAZARDS associated with moving parts”, “Expelled parts HAZARD”; ADD “HAZARDS associated with surfaces, corners and edges”, “Instability HAZARDS”, “Pressure vessels and parts subject to pneumatic and hydraulic pressure”, “HAZARDS associated with support systems” (see 201.9 of this document, Section IV of the 2000 edition);
- ADD “Lasers and light emitting diodes (LEDs)”, “Other visible electromagnetic radiation”, “Infrared radiation”, “Ultraviolet radiation” (see 201.10 of this document);
- ADD “Thermal and other HAZARDS from INTERCONNECTION
CONDITIONS with LASERS”; AMEND “APPLIED PARTS not intended to
supply heat to a PATIENT”, “GUARDS”, “Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS”, “Thermal and other HAZARDS from
INTERCONNECTION CONDITIONS with HF SURGICAL EQUIPMENT” (see
201.11 of this document);
- ADD “USABILITY”, “Alarm systems”, "Protection against hazardous output” (see 201.12 of this document);
- ADD “Image observation” (see 201.13 of this document);
- ADD “PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)” (see
201.14 of this document);
- ADD “Construction of connectors”; AMEND “General”, “Rough handling test” (see 201.15 of this document);
- ADD “ME SYSTEMS” (see 201.16 of this document);
- AMEND “Electromagnetic compatibility of ME EQUIPMENT and ME
SYSTEMS”, “Electromagnetic compatibility - Requirements and tests” (see 201.17 and Clause 202 of this document, Clause 36 of the 2000 edition). This document uses the redrafting method to amend and adopt IEC 60601-2-18:2009 “Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment”.
The technical differences between this document and IEC 60601-2-18:2009 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 IEC 60601-1-2:2007 with YY 9706.102, which is modified from the international standard (see Clause 202);
● REPLACE IEC 60601-2-2:2017 with GB 9706.202, which is modified from the international standard (see 201.7.9.2.14, 201.11.101.2);
● REPLACE IEC 60601-2-37 with GB 9706.237, which is modified from the
international standard (see 201.4.1.102).
- DELETE 201.7.9.2.12 Cleaning, disinfection and sterilization, to adapt to the technical conditions of China.
The following editorial changes have been made to this document:
- AMEND the informative Annex BB;
- Replace the international documents in the bibliography with the corresponding Chinese documents, as follows:
● REPLACE ISO 594 with GB/T 1962 (all parts), which is identical to the international standard;
● REPLACE ISO 14971 with YY/T 0316, which is identical to the international standard;
● REPLACE IEC 60601-1-8 with YY 9706.108, which is modified from the
international standard.
- DELETE the index of defined terms of the international standard.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights.
This document was proposed and shall be under the jurisdiction of the National Medical Products Administration.
The previous released versions replaced by this document are as follows: - It is first published in 2000 as GB 9706.19-2000;
- This is the first revision.
Medical electrical equipment - Part 2-18: Particular
requirements for the basic safety and essential performance
of endoscopic equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ENDOSCOPIC EQUIPMENT together with its INTERCONNECTION
CONDITIONS and INTERFACE CONDITIONS.
201.1.2 Object
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ENDOSCOPIC EQUIPMENT (as
defined in 201.3.204).
NOTE: This object includes endoscopic intense light source equipment which is part of the ENDOSCOPIC EQUIPMENT including its supply unit, therefore IEC 60601-2-57 does not apply. 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 applies as modified in Clause 202. GB 9706.103 does not apply. All other published collateral standards in the GB 9706 series apply as published. 201.1.4 Particular standards
Replacement:
In the GB 9706 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the

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