标准编号:	GB 9706.218-2021
中文名称:	医用电气设备 第2-18部分：内窥镜设备的基本安全和基本性能专用要求
英文名称:	Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment
中标分类:	C40    医用光学仪器设备与内窥镜
行业分类:	GB    国家标准
ICS分类:	11.040.70 11.040.70    眼科设备 11.040.70
发布机构:	国家市场监督管理总局 国家标准化管理委员会
发布日期:	2021-12-01
实施日期:	2023-5-1
标准状态:	现行
替代旧标准:	GB 9706.19-2000 医用电气设备 第2部分：内窥镜设备安全专用要求
翻译语言:	英文
文件格式:	PDF
中文字符数:	41000 字
翻译价格(元):	2670.00 元
交付时间:	付款后 1 个工作日

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

医用电气设备 第2-18部分：内窥镜设备的
基本安全和基本性能专用要求
201.1 范围、目的和相关标准
除下述内容外，通用标准的第1章适用。
201.1.1 范围
替换：
本文件规定了内窥镜设备的基本安全与基本性能，连同其相关的互连条件和接口条件。
201.1.2 目的
替换：
本文件的目的是给出了内窥镜设备基本安全与基本性能要求(如201.3.204定义)。
注：该目的包括作为有供给装置的内窥镜设备一部分的内窥镜强光源设备，因此IEC 60601-2-57不适用。
201.1.3并列标准
增补：
本文件引用通用标准第2章以及本文件201.2中所列适用的并列标准。
YY 9706.102在第202章修改后适用。GB 9706.103不适用。已出版GB 9706系列标准中的已出版的并列标准适用。
201.1.4专用标准
替换：
在GB 9706系列中，专用标准可依据所考虑的专用ME设备，修改、替换或删除通用标准和并列标准中包含的要求。并可增补其他基本安全和基本性能要求。
专用标准的要求优先于通用标准的要求。
在本文件中将GB 9706.1—2020称为通用标准。并列标准用它们各自的文件编号表示。
本文件中章和条的编号前加前缀“201”与通用标准相对应(例如，本文件中201.1对应通用标准第1章)，或者加前缀“20×”与适用的并列标准相对应，此处“×”是并列标准对应国际标准编号的末位数字(例如，本文件中202.4对应并列标准YY 9706.102中第4章的内容，本文件中203.4对应并列标准GB 9706.103第4章的内容等)。
通过使用下列词语来规范对通用标准文本的变更：
“替换”即通用标准的章或条或适用的并列标准完全由本文件的内容所替换。
“增补”即本文件的内容作为通用标准或适用的并列标准的补充。
“修改”即通用标准的章或条或适用的并列标准由本文件的内容所修改。
作为对通用标准补充的条、图和表从201.101开始编号。然而，由于通用标准中定义的编号从3.1～3.147，因此本文件中增补的定义从201.3.201开始编号。增补附录的编号为AA、BB等，增补列项用aa)、bb)等表示。
对于增补到并列标准中的条、图或表从“20×”开始编号，此处“×”是并列标准对应编号的末位数字，例如202对应YY 9706.102，203对应于GB 9706.103等。
“本标准”一词是通用标准、任何适用的并列标准及本文件的统称。
若本文件中没有相应的章和条，则通用标准或适用的并列标准中的章和条，即使可能不相关，也均适用。对通用标准或适用的并列标准中的任何部分，即使可能相关，若不采用，则本文件对其给出说明。
201.2规范性引用文件
下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本(包括所有的修改单)适用于本文件。
除下述内容外，通用标准的第2章适用。
修改：
YY 9706.102医用电气设备 第1-2部分：基本安全和基本性能的通用要求 并列标准：电磁兼容 要求和试验(YY 9706.102—2021，IEC 60601-1-2：2007，MOD)
增补：
GB 9706.202 医用电气设备 第2-2部分：高频手术设备及高频附件的基本安全和基本性能专用要求(GB 9706.202—2021，IEC 60601-2-2：2017，MOD)
GB 9706.237 医用电气设备 第2-37部分：超声诊断和监护设备基本安全和基本性能专用要求(GB 9706.237—2020，IEC 60601-2-37：2015，MOD)
ISO 8600-1 内窥镜 医用内窥镜和内治疗器械 第1部分：一般要求(Endoscopes—Medical en-doscopes and endotherapy devices—Part 1：General requirements)
201.3术语和定义
通用标准界定的以及下列术语和定义适用于本文件。
增补：
201.3.201
*电容耦合高频电流capacitively coupled HF current
带电的内治疗器件是应用于内窥镜的高频手术设备应用部分，由于带电的内治疗器件的电容耦合会不可避免的产生高频电流。
201.3.202
*内窥镜应用配置 configuration for endoscope application
以接口条件和/或互连条件的方式，将下述一件或多个的内窥镜设备组合：
——带电内治疗器械；
——医用电气设备，以下简称ME设备；
——非医用电气设备；
——医用电气系统，以下简称ME系统。
注：并非内窥镜应用配置的所有章条号都包含在专用标准之内，见附录AA中图AA.101的图解说明。
201.3.203
内窥镜 endoscope
通过自然腔道或手术创建通道进入人体腔内，采用光学或非光学方式进行查看，用于检查、诊断和治疗的医疗器械。
[来源：ISO 8600-1，3.1]
注1：内窥镜可以是硬性、软性和以胶囊形式，每种都可以有不同的图像获得系统(例如通过镜头或电子/超声传感器)和不同的图像传输系统[例如光学方法(通过镜头或光纤束)，或导电/电子]。
注2：注1与ISO 8600-1中定义3.1的注1不同，它包括胶囊内窥镜。
201.3.204
内窥镜设备 endoscopic equipment
预期用途所需的，和供给装置一起的带电内窥镜。
201.3.205
内治疗器械endotherapy device
在内窥镜术过程中，预期插入自然腔道或手术创建通道，不论是与内窥镜相同或不同的孔道进入人体腔内，进行检查、诊断和治疗的医疗器械。
注：内治疗器械包括插入内窥镜或内治疗器件的器械，如套管、穿刺管或滑管等。内治疗器件包括插入开口，而不是通过内窥镜开口的器械，确保内窥镜观察下实现预期用途的器械安全。
[来源：ISO 8600-1，3.2]
201.3.206
*带电内窥镜 energized endoscope
内窥镜是ME设备的应用部分，应用能量来进行内部观察或成像。
注：例如光照明和信号处理。
201.3.207
*带电内治疗器械energized endotherapy device
内治疗器械是ME设备的应用部分，无论是否是内窥镜设备，通过内窥镜相同孔道，或第二或附随的孔道进入患者体内，使用能量达到预期用途。
注：例如高频电流，超声或激光。
201.3.208
高频high frequency；HF
频率一般高于200 kHz。
[来源：IEC 60601-2-2：2009，201.3.218]
201.3.209
高频手术设备HF surgical equipment
预期用于外科手术的ME设备，包括附件，例如通过高频电流的方式对生物组织切割或电凝。
[来源：IEC 60601-2-2：2009，201.3.222]
201.3.210
互连条件 interconnection condition
当一支或多支带电的内窥镜同时与一个或多个带电内治疗器械使用时，保证基本安全所应满足的条件。
201.3.211
接口条件 interface condition
在内窥镜设备配置中，对于内窥镜设备与其他ME设备或非ME设备之间的任何功能连接，保证基本安全所应满足的条件。
201.3.212
光发射部分light emission part
带电内窥镜环绕光发射窗周围的插入端部分，描述如下：
插入端部分的表面区域，是最大直径的三倍范围内，直视带电内窥镜在头端部(拿掉端部顶盖)测量，或侧视带电内窥镜在光发射窗口中心测量，纵向距离从光发射窗口中心测量，最小为10 mm，最大为25 mm，见图201.101。

光发射窗口
侧视内窥镜
直视内窥镜
阴影表示光发射部分
图201.101 光发射部分的识别
201.3.213
中性电极neutral electrode；NE
连接到患者身体且面积相对较大的电极，预期用途是为高频电流提供回路，为人体组织中提供的低密度电流，以避免如不必要的灼烧之类的物理效应。
注：中性电极也称为板、电极板、阳极、负极板、返流电极或分散电极。
[来源：IEC 60601-2-2：2009，201.3.227]
201.3.214
额定附件电压rated accessory voltage
对于单极高频手术附件，中性电极连接到患者身体的最大峰值HF输出电压。对于双极高频手术附件，成对的相反电极的最大峰值HF输出电压。
[来源：IEC 60601-2-2：2009，201.3.228]
201.3.215
*供给装置supply unit
直接与内窥镜连接的ME设备的部分，提供必要的功能而构成带电内窥镜。
201.3.216
超声诊断设备ultrasonic diagnostic equipment
预期用于超声医疗检查的ME设备。
[来源：GB 9706.237—2020，201.3.217]
201.4通用要求
除下述内容外，通用标准的第4章适用。
201.4.1 应用ME设备或ME系统的条件
增补条款：
201.4.1.101 *带电内治疗器械
如果其他可适用的专用标准中给出内治疗器械的要求与本文件互连条件的要求相冲突，以本文件的要求为准。
201.4.1.102超声诊断设备
既是内窥镜设备也是超声诊断设备，在超声安全方面，用于超声诊断的部分应符合GB 9706.237的要求，其他部分应符合本文件的要求。
201.4.1.103 *供给装置
如果供给装置能够提供多项功能并适用不同的专用标准，适用的部分应遵循相关的专用标准要求。
201.4.3 主要性能
增补条款：
201.4.3.101 *补充主要性能要求
表201.101里列出的章条中补充的主要性能要求。
表201.101 主要性能要求列表
要求 章条号
如果操作者所观察的图像有意外的图像朝向，确保无不可接受的风险 制造商需规定适用性和条件
如果对与精确诊断或治疗必不可少特殊的光谱输出或频率，其规定缺少或重大错误，经过培训的操作员也不能识别，确保无不可接受的风险 201.12.4.4
内窥镜手术过程中，操作人员观察实时影像而不是录像，确保无不可接受的风险 201.13.1.101

注：见201.7.9.2.2 g)，与主要性能要求相关的警告和安全提示。
201.4.6 *与患者接触的ME设备或ME系统
增补：
本文件规定光导电缆是ME系统与患者接触的应用部分，除非风险管理文件表明另有特别配置。
检查风险管理文件，是否符合要求。
201.4.7 ME设备单一故障状态
增补：
对于单一故障安全，规定制造商应考虑到互连条件和接口条件是风险管理过程的一部分。
检查风险管理文件，是否符合要求。
201.5 ME设备试验的通用要求
除下述内容外，通用标准的第5章适用。
201.5.1 型式试验
增补：
带电内窥镜定义必要地包括仅通过光能传递的内窥镜，这种内窥镜与供给装置提供了F型应用部分隔离。这些条件下，不会对患者或操作员产生不可接受的风险。因此不需要进行第8章的电气安全型式试验。
201.5.7 *潮湿预处理
增补：
内窥镜设备调节孔盖不用工具可以打开，但一旦打开，设备就会断电(如联锁装置)，潮湿预处理过程中检修盖可以不打开，除非风险管理过程建议，在检修盖打开期间内窥镜设备可以暴露在高湿度的环境下。
按照预期用途或使用说明书要求在使用前提供灭菌和/或消毒过程的带电内窥镜和带电内治疗器械，在相关测试前视情况，按照本条要求可以不进行潮湿预处理，但应替代通用标准的11.6.6和/或11.6.7。
201.6 ME设备和ME系统分类
除下述内容外，通用标准的第6章适用。
201.6.2防触电保护
替换最后一段：
内窥镜设备的应用部分分类为：BF型应用部分或CF型应用部分(见8.3)。这些应用部分可分为防除颤应用部分。
201.7 ME设备的标识、标记和随机文件
除下述内容外，通用标准的第7章适用。
201.7.2 ME设备或部件的外部标记
201.7.2.1 ME设备和可互换部件的标记最低要求
如果ME设备、部件或附件的尺寸，或内窥镜属性不准许标出通用标准7.2.2～7.2.20(包括7.2.20)规定的所有标识，至少标出通用标准7.2.2、7.2.5、7.2.6(非永久安装的ME设备)，7.2.10和7.2.13(如适用的话)中规定的标识，其余标识在随附文件中完整地给出。如果ME设备或附件的标识实在不可行的话，应在单个的包装上标出。
预期一次性使用的材料、器件、附件或ME设备或其包装上，应标上“请勿重复使用”的字样，或ISO 7000-1051(2004-01)所规定的标志(见通用标准附录D的表D.1中符号28)。
201.7.2.9 *IP分类
增补：
所提供的说明书中已说明可允许再处理方法和参数的带电内窥镜和内治疗器械不包含在本要求中。专用标准没有提出要求使用符号对再处理过程进行识别。见通用标准7.9.2.12。
201.7.2.10应用部分
增补：
如果应用部分的标识不可行，所要求的标识可在单独包装上标出。
通过检查是否符合要求。
增补条款：
201.7.2.101 备用标识
只要需要获得信息时就能看见标识，内窥镜设备输出装置(显示器)上使用者所需的信息应与考虑通用标准7.2.3、7.2.5、7.2.11和7.2.13要求的在设备上的标识一致。
通过检查可用性工程过程的结果和/或随机文件是否符合要求。
201.7.2.102 *照明灯泡
不使用工具带有可更换的照明灯泡的供给装置应给出永久固定和清晰可见的标识，标在供给装置内部或外部的灯泡附近，给出型号或型式参数(优先使用表201.D.101中规定的符号111)。
安装在内窥镜头端部的可更换照明灯，至少应在随附文件中给出型号或型式参数。
仅由售后服务人员用工具才能更换照明灯泡，至少应在随附文件中给出型号或型式参数。
201.7.4控制器标识与说明书
201.7.4.3测量单位
增补：
内窥镜和内治疗器械，度量值‘French’或者‘Charrière’用符号F，为等效周长表示环形或非环形截面尺寸，定义为：
Fr=3u/π
式中：
u——截面周长，单位为毫米(mm)。
注：来源于ISO 8600-1。
201.7.6 符号
201.7.6.2 附录D中的符号
增补：
制造商可选择使用符号表示内窥镜设备的功能，如果使用符号，要在使用说明书中解释。附录D给出优先使用功能的符号。
201.7.9 随机文件
201.7.9.2使用说明书
201.7.9.2.2 *警告与安全提示
增补：
如适用，内窥镜设备使用说明书应包括下述的警告与安全提示。
涉及内窥镜设备的警示与安全提示：
a)如果应用部分的表面温度可能会超过41℃，给出警告信息(并见201.11.1.2.2)。
b)如果内窥镜的光发射窗口可能会发射出高能辐射光，引起光发射窗口前的温度过高，需要警告信息，并给出风险最小的建议。
c)如果内窥镜设备出现故障，防止不可接受风险的建议。
d)更换照明灯时，防止可能会引起如烧伤和眼部伤害等危害情况的建议。
e)如果仅采用供给装置与光导束输出口间的绝缘，多重供给装置和/或光导束的带电内窥镜，给出其F型应用部分的状态警告信息。
f)给出每次使用前，应检查进入患者体内的带电内窥镜插入部外表面，确保没有会造成伤害的粗糙表面、尖锐边缘或突出物的说明。
g)给出每次使用前，或改变观察模式/设置后，操作员应检查以确保通过内窥镜观察到的图像是实时(而不是存储的图像)和具有正确图像朝向的说明。
涉及互连条件的警告和安全提示：
h)内窥镜应用配置中使用了BF型应用部分或CF型应用部分的其他ME设备，给出其应用部分互连条件的警告信息。
i)给出例如过量气体喷注、高频手术前惰性气体或激光辅助气体导致气体栓塞的风险结果。
j)给出当带电内窥镜和带电内治疗器械一起使用时，可能会增加患者身上漏电流的警示信息。需要特别注意的是，如果使用CF型应用部分的内窥镜，此情况下应使用CF型应用部分的带电内治疗器械，保证患者身上的总漏电流最小化。
k)给出使用高频带电内治疗器械区域，倘若爆炸性气体浓度危险避免的说明。
l)如果带电内窥镜和/或带电内治疗器械与激光设备一起使用，给出安全使用建议，包括避免对操作员潜在的眼伤害，如通过配戴合适的防滤光眼镜，或在带电内窥镜的目镜上配上合适的滤光片。
m)给出设备使用前，按照使用说明中限定的安全使用准则，对使用了附件和/或带电内治疗器械的内窥镜设备进行兼容性检查的说明。
n)给出每次使用前，应检查进入患者体内的带电内治疗器械外表面，确保没有会造成伤害的粗糙表面、尖锐边缘或突出物的说明。
涉及接口条件相关的警告和安全提示：
o)当内窥镜设备在内窥镜应用配置范围内，和附件、其他ME设备和/或非ME设备一起使用时，给出避免因为同时使用而造成风险建议(见通用标准16.2和201.15.4.1)。
查看使用说明，检查是否符合要求。
201.7.9.2.14附件、辅助设备和材料
增补：
当带电内治疗器械与高频手术设备一起使用时，使用说明书中给出涉及这与GB 9706.202的相关要求的安全使用建议。