Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This document is developed in accordance with the rules given in GB/T 1.1-2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents.
This is Part 2-18 of GB 9706 Medical electrical equipment. The following parts of GB 9706 have been published:
——Part 1: General requirements for basic safety and essential performance;
——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 basic safety and essential performance of an aesthetic 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 basic safety and essential performance of baby 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 medical diagnostic X-ray tube assemblies;
——Part 2-29: Particular requirements for the basic safety and essential performance of adiotherapy 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 basic safety and essential performance 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 mammographic X-ray equipment and mammographic sterotactic devices;
——Part 2-54: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment;
——Part 2-60: Particular requirements for the basic safety and essential performance of essential performance of X-ray equipment for radiography and radioscopy;
——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. In addition to structural adjustment and editorial changes, the following main technical changes have been made with respect to GB 9706.19-2000:
——In Clause “Scope”, "supplement" is modified to "replacement", and "essential performance" is added (see 201.1.1 hereof; 1.1 of Edition 2000);
——"Essential performance" is added to the object. (see 201.1.2 hereof; 1.2 of Edition 2000);
——“Collateral standards” is added (see 201.1.3 hereof);
——"Supplement" in the particular standards is modified to "Replacement" (see 201.1.4 hereof; 1.3 of Edition 2000);
——The Clause “Normative references” is added (see Clause 201.2 hereof);
——The terms "configuration for endoscopic application", "energized endoscope", "energized endotherapy devices", "high frequency", "interface condition", "neutral electrode" and "rated accessory voltage" are added to the terms and definitions, and "endoscopically-used accessory" is modified to "endotherapy devices" (see 201.3 hereof; Clause 2 of Edition 2000);
——In the general requirements, the subclauses “Energized endotherapy devices”, "Ultrasonic diagnostic equipment", "Supply units" and "Additional essential performance requirements" are modified, and the subclauses "Essential performance", "ME equipment or ME system parts that contact the patient" and "Single fault condition for ME equipment" are added (see 201.4 hereof; Clause 3 of Edition 2000);
——The subclauses "General requirements for testing" is modified to "General requirements for testing of ME equipment", and the subclauses "Type test" and "Humidity pre-treatment" are added (see 201.5 hereof; Clause 4 of Edition 2000);
——The subclauses "Classification" is modified to "Classification of ME equipment and ME systems", and the subclause "Protection against electric shock" is added (see 201.6 hereof; Clause 5 of Edition 2000);
——The subclauses "Identification, marking and documents" is modified to "ME equipment identification, marking and documents"; the subclauses "Marking on the outside of ME equipment or ME equipment parts" and "Accompanying documents" are modified, and the subclauses "Marking of controls and instruments" and "Symbols" are added (see 201.7 hereof; Clause 6 of Edition 2000);
——The subclauses "Classification of applied parts" and "Separation of parts" are added, and the subclauses "Insulation", "Creepage distances and air clearances" are modified (see 201.8 hereof);
——The subclauses "Hazards associated with moving parts" and "Expelled parts hazards” are modified, and the subclauses "Hazards associated with surfaces, corners and edges", "Instability hazards", "Pressure vessels and parts subject to pneumatic and hydraulic pressure" and "Hazards related to support systems" are added (see 201.9 hereof; Clause 4 of Edition 2000);
——The subclauses "Lasers and light emitting diodes (LEDs)", "Other visible electromagnetic radiation", "Infrared radiation" and "ultraviolet radiation" are added (see 201.10):
——The subclauses "Thermal and other hazards from interconnection conditions with lasers” are added, and the subclauses "Applied parts not intended to supply heat to a patient", "guards", "Ingress of water or particulate matter into ME equipment and ME systems" and "Thermal and other hazards from interconnection conditions with HF surgical equipment" are modified (see 201.11 hereof);
——The subclauses "Usability", "Alarm systems" and "Protection against hazardous output" are added (see 201.12);
——The subclause "Image observation" is added (see 201.13 hereof);
——The subclause “Programmable electrical medical systems (PEMS)” is added (see 201.14 hereof);
——The subclause "Construction of connectors" is added, and the subclauses "General" and "Rough handling test" are modified (see 201.15 hereof);
——The subclause “ME systems” is added (see 201.16 hereof);
——The subclauses “Electromagnetic compatibility of ME equipment and ME systems" and "Electromagnetic compatibility – Requirements and tests" are modified (see 201.17 hereof; Clause 36 of Edition 2000).
This document is modified in relation to IEC 60601-2-18: 2009 Medical electrical equipment—Part 2-18: Particular requirements for the safety of endoscopic equipment.
The main technical differences with respect to IEC 60601-2-18: 2009 and their reasons are as follows:
——The adjustments on technical differences have been made for the normative references of this standard to adapt to the technical conditions in China, which are mainly reflected in 201.2 "Normative references”, with the following specific content:
• IEC 60601-1-2: 2007 is replaced by YY 9706.102 which is modified in relation to the international standard (see Clause 202);
• IEC 60601-2-2: 2017 is replaced by GB 9706.202 which is modified in relation to the international standard (see 201.7.9.2.14 and 201.11.101.2 hereof);
• IEC 60601-2-37 is replaced by GB 9706.237 which is modified in relation to the international standard (see 201.4.1.102 hereof).
——The subclause 201.7.9.2.12 “Cleaning, disinfection and sterilization” is deleted to adapt to the technical conditions of China.
The following editorial changes have been made in this document:
——Annex BB is modified;
——The international standards related to the adoption of standards in the bibliography are replaced by Chinese standards, as follows:
• ISO 594 (all parts) is replaced by GB/T 1962 (all parts) which is identical to the international standard;
• ISO 14971 is replaced by YY/T 0316 which is identical to the international standard;
• IEC 60601-1-8 is replaced by YY 9706.108 which is modified in relation to the international standard.
——Alphabetical index of terms in international standards is deleted.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This document was proposed by and is under the jurisdiction of the National Medical Products Administration of the People’s Republic of China.
The previous editions of this document are as follows:
——It was first issued as GB 9706.19-2000 in 2000;
——This edition is the first revision.
Introduction
Medical electrical equipment safety standards, also known as 9706 series standards, consist of general standard, collateral standard, particular standard, guidance and explanation.
——General standards: generally applicable safety standards for medical electrical equipment, that is, equipment conforming to the definition of medical electrical equipment shall meet the requirements of this basic standard.
——Collateral standards: generally applicable safety standards for medical electrical equipment, but in most cases, it is only required to meet the requirements of this standard for equipment with certain specific functions or characteristics.
——Particular standards: safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have particular standards.
——Guidance and explanation: the application guidance and explanation of the relevant requirements and clauses in the standards involved.
Among the GB 9706 series, in addition to the published standards and this document, the following standards have been included in the plan:
——Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrilllator. The object is to establish particular requirements for the basic safety and essential performance of cardiac defibrilllator;
——Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. The object is to establish particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
——Part 2-65: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems. The object is to establish particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems.
This document covers the requirements for the basic safety and essential performance of endoscopic equipment. This document modifies and supplements GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance.
In this document, the asterisk (*) as the first character of a title or the beginning of a paragraph or table title indicates that there are particular guidance and rationales related to the item in Annex AA. The relevant contents of Annex AA not only contribute to the correct application of this document, but also accelerate the process of revising standards due to changes in clinical practice or technological developments in a timely manner.
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 particular standard.
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 particular ME equipment under consideration, and may add other basic safety and essential performance requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, GB 9706.1-2020 is referred to in this document as the general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of the YY 9706.102 collateral standard, 203.4 in this document addresses the content of Clause 4 of the GB 9706.103 collateral standard, etc.).
The changes to the text of the general standard are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for YY 9706.102, 203 for GB 9706.103, etc.
The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the 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 documents contain provisions which, through reference in this text, constitute provisions 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:
Amendment:
YY 9706.102 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests (YY 9706.102-2021, IEC 60601-1-2: 2007, MOD)
Addition:
GB 9706.202 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, IEC 60601-2-2: 2017, MOD)
GB 9706.237 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (GB 9706.237-2020, IEC 60601-2-37: 2015, MOD)
ISO 8600-1 Endoscopes—Medical endoscopes and endotherapy devices—Part 1: General requirements
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in general standards, as well as the following, apply.
Addition:
201.3.201
* capacitively coupled HF current
unavoidable high frequency current flowing due to capacitive coupling from an energized endotherapy device that is the applied part of HF surgical equipment to the endoscope
201.3.202
* configuration for endoscope application
combination of endoscopic equipment by means of interface conditions and/or interconnection conditions with one or more of the following:
——energized endotherapy device(s);
——medical electrical equipment, hereinafter referred to as ME equipment;
——non-medical electrical equipment;
——medical electrical system, hereinafter referred to as ME system.
Note: Not all of the items in the configuration for endoscopic application are included in the scope of this particular standard. See Figure AA.101 in Annex AA for a diagrammatic explanation.
Foreword i
Introduction vii
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME equipment
201.6 Classification of ME equipment and ME systems
201.7 ME equipment identification, marking and documents
201.8 Protection against electrical hazards from ME equipment
201.9 Protection against mechanical hazards of ME equipment and ME systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME equipment
201.16 ME systems
201.17 Electromagnetic compatibility of ME equipment and ME systems
202 Electromagnetic compatibility—Requirements and tests
Annexes
Annex C (Informative) Guide to marking and labelling requirements for ME equipment and ME systems
Annex D (Informative) Symbols on marking
Annex J (Informative) Survey of insulation paths
Annex AA (Informative) Particular guidance and rationale
Annex BB (Informative) Clauses of this document addressing essential principles of safety and performance of medical devices
Bibliography
Figure 201.101 Identification of light emission part
Figure 201.102 Measurement of capacitively coupled HF current from conductive parts of an endoscope
Figure 201.J.101 Insulation example
Figure 201.J.102 Insulation example
Figure 201.J.103 Insulation example
Table 201.101 List of essential performance requirements
Table 201.C.101 Marking on the outside of endoscopic equipment or its parts
Table 201.C.102 Marking on the inside of endoscopic equipment or its parts
Table 201.C.104 Accompanying documents, general
Table 201.C.105 Accompanying documents, instructions for use
Table 201.D.101 Symbols for marking endoscopic equipment or its parts
Table BB.1 Correspondence between this document and 2020 Announcement No. 18 of National Medical Products Administration
