标准编号:ISO 28620:2010
中文名称:医疗器械 便携式非电驱动输液器具
英文名称:Medical devices — Non-electrically driven portable infusion devices
发布日期:2010-02
标准范围
This International Standard specifies essential requirements and related test methods for non-electricallydriven portable infusion devices1). It applies to devices designed for continuous (fixed or adjustable) flowand/or for bolus application.These devices can be used in health care and non-health care settings. They can be applied or administeredby health care professionals or by the intended patient.These devices can be pre-filled by the manufacturer or filled before use by a health care professional or theintended patient.