FDA Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices
标准简介
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices[附网盘链接]是Food And Drug Administration于过去发布的FDA标准，适用于US。标准截图
![Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices[附网盘链接]](/img/20210914103559xv099.jpg)
标准文档说明
标准文档类型为Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Assessment of Radiofrequency-
Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction This guidance provides an assessment paradigm for radiofrequency (RF)-induced heating for multi-configuration passive medical devices in the magnetic resonance (MR) environment, including multi-component and single-component device types with various dimensions and shape. Multi-component passive devices, such as orthopedic fixation devices, may result in a very large number of possible device configurations and combinations of individual components. Single-component devices, such as cardiovascular stents, are also frequently available in multiple sizes or configurations. For these multi-configuration passive devices, it can be challenging to leverage RF-induced heating testing from one device configuration or combination to other device configurations or combinations because the geometry or configuration of the device can affect heating in an unknown manner. As a result, the total number of possible configurations or combinations that need to be assessed for RF-induced heating of some passive devices can be very large. This document provides an approach to reduce the number of possible device configurations or combinations to a manageable number for the testing of RF-induced heating in the MR environment. Additionally, this document provides guidance on how to assess RF-induced device heating for multi-configuration passive medical devices. The information provided in this guidance is intended to be used to support MR Conditional labeling claims in conjunction with 1
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