亚洲不卡一区二区av,国产精品乱一区二区三区,另类亚洲综合区图片小说区,99人妻精品日韩欧美一区二区`

GB 9706.218-2021

Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment (English Version)

GB 9706.218-2021
Standard No.
GB 9706.218-2021
Language
Chinese, Available in English version
Release Date
2021
Published By
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest
GB 9706.218-2021
Replace
GB 9706.19-2000
Scope
Replacement: This document specifies the basic safety and basic performance of endoscopic equipment, together with its related interconnection conditions and interface conditions. 201. For the increasing number of endoscopic applications, the use of live therapeutic devices may cause other specific standards to inappropriately use the endoscopic interconnection and interface conditions in the endoscopic application configuration. In the event of a conflict of requirements or tests, this clause stipulates that the particular standard shall take precedence. The reason is that endoscopic use of ME EQUIPMENT and/or its applied parts should be considered differently from non-endoscopic use due to the structural and physical requirements of endoscopic and endotherapeutic devices. The scope of the third edition of the standard differs from previous editions by including accessories inserted into the patient's body through a second or subsequent puncture, which previously included only accessories inserted into the patient's body through an endoscopic orifice. The expansion of the scope will inevitably lead to the definition of endoscope application configuration, including all relevant interface conditions. Definition 201.3.201 Capacitively coupled high frequency current
Introduction

Analysis of core changes in the standard

Key changes Requirements of the 2000 version Requirements of the 2021 version
Scope of application Only supplement the general standards Replace the general standards and add basic performance requirements
Definition of terms 12 core terms Added 16 technical definitions such as capacitive coupled high-frequency current
Electromagnetic compatibility Basic test requirements Clearly define the acceptable criteria for temporary image interference

Key technical requirements

Capacitive coupling high-frequency current protection

According to 201.11.101.2, when the endoscope is used in conjunction with high-frequency surgical equipment:

  • High-frequency current of exposed conductive parts ≤ 50mA (test method see Figure 201.102)
  • Non-permanent insulating coatings (such as paint) are prohibited
  • The impact of single fault conditions needs to be evaluated in the risk management file

Implementation points

Documentation requirements

The accompanying documents must include the following warning statement (201.7.9.2.2):

  1. Image orientation verification requirements (distinguishing between real-time images and stored images)
  2. Risk of embolism caused by inert gases during high-frequency surgery
  3. Eye protection measures when used in conjunction with laser equipment

Test exemption conditions

The following situations can be exempted from moisture pretreatment (201.5.7):

  • Instruments used immediately after sterilization/disinfection
  • Instrument cover with interlocking device

GB 9706.218-2021 Referenced Document

  • 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 9706.237 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • ISO 8600-1 Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements*, 2025-03-04 Update
  • YY 9706.102 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standards: Electromagnetic compatibility requirements and tests

GB 9706.218-2021 history

  • 2021 GB 9706.218-2021 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment
  • 2000 GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment

GB 9706.218-2021 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment has been changed from GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment.


GB 9706.218-2021 -All Parts

GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance GB 9706.10-1997 Medical electrical equipment. Part 2: Particular requirements for safety of therapeutic X-ray generators GB 9706.103-2020 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment GB 9706.11-1997 Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis GB 9706.12-1997 Medical electrical equipment. Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment GB 9706.13-2008 Medical electrical equipment.Part 2:Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment GB 9706.14-1997 Medical electrical equipment--Part 2: Particular requirements for the safety of associated equipment of X-ray equipment GB 9706.15-2008 Medical electrical equipment.Part 1:General requirements for safety.1.Collateral standard:Safety requirements for medical electrical systems GB 9706.16-2015 Medical electrical equipment.Part 2:Particular requirements for the safety of radiotherapy simulators GB 9706.17-2009 Medical electrical equipment.Part 2:Particular requirements for the safety of gamma beam therapy equipment GB 9706.18-2006 Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray equipment for computed tomography GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment GB 9706.2-2003 Medical electrical equipment--Part 2-16: Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment GB 9706.20-2000 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment GB 9706.201-2020 Medical electrical equipment—Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV GB 9706.202-2021 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 9706.203-2020 Medical electrical equipment—Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment GB 9706.204-2022 Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators GB 9706.205-2020 Medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment GB 9706.206-2020 Medical electrical equipment—Part 2-6: Particular requirments for the basic safety and essential performence of microwave therapy equipment GB 9706.208-2021 Medical electrical 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 GB 9706.21-2003 Medical electrical equipment--Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors GB 9706.211-2020 Medical electrical equipment—Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment GB 9706.212-2020 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators GB 9706.213-2021 Medical electrical equipment—Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation GB 9706.216-2021 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment GB 9706.217-2020 Medical electrical equipment—Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment GB 9706.218-2021 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment GB 9706.219-2021 Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators GB 9706.22-2003 Medical electrical equipment--Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy GB 9706.222-2022 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment GB 9706.224-2021 Medical electrical equipment—Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers GB 9706.225-2021 Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs GB 9706.226-2021 Medical electrical equipment—Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs GB 9706.227-2021 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment GB 9706.228-2020 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis GB 9706.229-2021 Medical electrical equipment—Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators GB 9706.23-2005 Medical electrical equipment-Part 2-43:Particular requirements for the safety of X-ray equipment for interventional procedures GB 9706.236-2021 Medical electrical equipment—Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy GB 9706.237-2020 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment GB 9706.239-2021 Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment GB 9706.24-2005 Medical electrical equipment-Part 2-45:Particular requirements for the safety of mammographic X-ray equipment and mammographic sterotactic devices



Copyright ?2007-2025 ANTPEDIA, All Rights Reserved