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.

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