T/SAMD 0004-2024 Active Group standards

T/SAMD 0004-2024 Quantitative Evaluation Technical Requirements for Electrophysiological Acquisition Performance of Medical Electronic Instruments

Publish Date: 2024-11-14 Implement Date: 2024-11-14 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/SAMD 0004-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2024-11-14

Implement Date: 2024-11-14

Scope

Scope: This document specifies the quantitative evaluation method for the digital acquisition performance of electrophysiological signals in medical electronic instruments. This document is applicable to the comprehensive evaluation of the signal quantification performance of active medical devices used for disease diagnosis and monitoring through digital human electrophysiological acquisition, and can be used for inspection, detection, and metrological testing during the R&D, production, and use of such medical electronic instrument products. Main technical content: This document specifies the quantitative evaluation method for the digital acquisition performance of electrophysiological signals in medical electronic instruments. This document is applicable to the comprehensive evaluation of the signal quantification performance of active medical devices used for disease diagnosis and monitoring through digital human electrophysiological acquisition, and can be used for inspection, detection, and metrological testing during the R&D, production, and use of such medical electronic instrument products.