T/SAMD 0002-2023 pipette tip for in vitro diagnostic medical devices
T/SAMD 0002-2023 pipette tip for in vitro diagnostic medical devices
Basic Information
Scope
Scope: This document specifies the technical requirements, test methods, inspection rules, marking, packaging, transportation, and storage of pipette needles used in in vitro diagnostic medical devices. This document is applicable to the design, production, testing, and acceptance of pipette needles used in in vitro diagnostic medical devices with a medium transfer and distribution volume of ≥1μL. Main technical content: This document specifies the technical requirements, test methods, inspection rules, marking, packaging, transportation, and storage of pipette needles used in in vitro diagnostic medical devices. This document is applicable to the design, production, testing, and acceptance of pipette needles used in in vitro diagnostic medical devices with a medium transfer and distribution volume of ≥1μL.