T/SAMD 0003-2024 Infusion Information Collection System
T/SAMD 0003-2024 Infusion Information Collection System
Basic Information
Scope
Scope: This document specifies the functional performance, safety, and test method requirements of infusion information collection systems, and can be used as a reference document for factory inspections or registration inspections of infusion information collection system manufacturers. This document applies to infusion information collection systems that provide alarm information during clinical infusion processes, supply power to infusion pumps/injection pumps, communicate with infusion pumps/injection pumps, and collect data. Main technical content: This document specifies the functional performance, safety, and test method requirements of infusion information collection systems, and can be used as a reference document for factory inspections or registration inspections of infusion information collection system manufacturers. This document applies to infusion information collection systems that provide alarm information during clinical infusion processes, supply power to infusion pumps/injection pumps, communicate with infusion pumps/injection pumps, and collect data.