T/CSBME 006-2019 Active Group standards

T/CSBME 006-2019 Evaluating the Safety of Active Implantable Devices in Magnetic Resonance Environment: Radiofrequency Safety Tissue Equivalent Simulation Medium Method

Publish Date: 2019-11-15 Implement Date: 2020-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBME 006-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2019-11-15

Implement Date: 2020-03-01

Scope

Scope: This standard implements a method for evaluating the radiofrequency safety of patients who have been implanted with active implantable medical devices (hereinafter referred to as AIMDs) during examinations in magnetic resonance (hereinafter referred to as MR) environments. Note 1: The requirements for non-implantable components are not within the scope of this section. Patients are expected to undergo MR scans using cylindrical-bore whole-body MR scanners designed for hydrogen nuclear imaging. The tests specified in this standard are intended for type testing of AIMDs, with the aim of confirming the safety of the interaction between AIMDs and the magnetic and electromagnetic fields associated with MR scanners. Note 2: The requirements for non-implantable components are not within the scope of this standard. The purpose of this standard is to evaluate whether the operation of AIMDs poses any serious hazards. It does not address specific compliance standards for products, nor does it involve determining the risks arising from the device's behavioral responses during these tests. Note 3: This standard is based on research data from 1.5T and 3.0T MR scanners. Other field strengths can refer to this method standard for guidance. Main technical content: This standard implements a method for evaluating the radiofrequency safety of patients who have been implanted with active implantable medical devices during examinations in magnetic resonance environments. The standard includes provisions on terms and definitions, general considerations regarding the application of standard requirements, and safety evaluation of active implantable medical devices in MR environments: radiofrequency safety equivalent tissue simulation medium method, etc.