- Standard No.
- GB 9706.218-2021
- Language
- Chinese, Available in English version
- Release Date
- 2021
- Published By
- 国家市场监督管理总局、中国国家标准化管理委员会
- 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
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
- 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.