T/SAMD 0005-2024 Guidelines for inspection and testing in the production process of medical electronic instruments, specifically for patient monitors, and basic function and performance testing

Scope

Scope: This document applies to the process inspection of important parameters during the production of patient monitors. This standard is only used for the verification of the basic functions and performance of the main modules during the production process. The important parameters referred to in the standard generally include electrocardiogram, non-invasive blood pressure, invasive blood pressure, blood oxygen, body temperature, and CO2 parameters. Manufacturers determine the inspection items based on the product functions; Main technical content: This document applies to the process inspection of important parameters during the production of patient monitors. This standard is only used for the verification of the basic functions and performance of the main modules during the production process. The important parameters referred to in the standard generally include electrocardiogram, non-invasive blood pressure, invasive blood pressure, blood oxygen, body temperature, and CO2 parameters. Manufacturers determine the inspection items based on the product functions.

Development Information

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