T/ZZB 2019-2020 One-time use, portable infusion pump, non-electric drive
T/ZZB 2019-2020 One-time use, portable infusion pump, non-electric drive
Basic Information
Scope
Main technical content: This document specifies the terms and definitions, basic requirements, components, technical requirements, test methods, inspection rules, marking, packaging, transportation, storage, and quality commitments for non-electrically driven disposable portable infusion pumps (hereinafter referred to as infusion pumps). This document applies to pumps that can deliver fluids sustainably, with or without autonomous control of fluid delivery. This document does not apply to: a) electrically driven or electrically controlled infusion pumps included in IEC 60601-2-24; b) implantable devices; c) enteral feeding pumps; d) percutaneous fluid delivery devices; e) infusion pumps where the power for delivery is not provided by the device itself, but is obtained through active intervention by the patient (e.g., devices that rely solely on gravity for power).