GB 9706.243-2021
Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (English Version)

Standard No.

GB 9706.243-2021

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 9706.243-2021

Replace

GB 9706.23-2005

Scope

Since the early 1980s, the use of fluoroscopy for visualization in a wide range of diagnostic and interventional procedures has grown substantially due to the need for indications using interventional X-ray equipment compliant with this part. All indications are that this growth will continue in the near future. These interventional procedures sometimes require prolonged fluoroscopy, and in some cases the x-ray field is in a constant position on the patient's surface. It should be noted that these procedures usually have considerable advantages for the patient in terms of overall clinical outcomes over other treatments. Table AA.1 provides examples of interventional procedures that may require prolonged fluoroscopy. Additionally, these procedures are performed by a variety of clinical personnel with varying degrees of radiation protection training. Because of these characteristics, interventional procedures differ from other procedures in medical diagnostic radiology in that the possibility of deterministic radiation effects such as radiation-induced skin damage cannot be ruled out. Table AA.1 Examples of prolonged fluoroscopy-guided interventional procedures that can produce definitive radiation effects Radiofrequency cardiac catheter ablation Transjugular intrahepatic portosystemic shunt (TIPS) Embolization Cardiac and noncardiovascular reconstruction Concern about the consequences of skin injury from radiation from interventional procedures has prompted some countries to issue specific cautions on avoiding injury during fluoroscopy-guided interventional procedures [4], [5]. These specific warnings include recommendations for interventional X-ray equipment with performance requirements for estimating absorbed dose to the skin. The purpose of the recommendation is to facilitate the identification of those skin regions where the absorbed dose resulting from irradiation approaches or exceeds the definitive damage threshold. Such confirmation is important in communication and patient care regarding signs of radiation injury symptoms or consideration of re-irradiation on the same skin area. In addition, this information helps medical practitioners and healthcare facilities improve interventional procedures and reduce the likelihood of future injuries. There are also some interventional procedures, and these specific radiation risks are not caused by the inherent characteristics of the operation, but are introduced by some or all other interventional risks, such as bleeding, infection, vascular injury, etc. Examples of some operations are given in Table AA.2.

GB 9706.243-2021 history

• 2021 GB 9706.243-2021 Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
• 2005 GB 9706.23-2005 Medical electrical equipment-Part 2-43:Particular requirements for the safety of X-ray equipment for interventional procedures

GB 9706.243-2021 Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures has been changed from GB 9706.23-2005 Medical electrical equipment-Part 2-43:Particular requirements for the safety of X-ray equipment for interventional procedures.

GB 9706.243-2021 -All Parts