ISO 28620:2010 医疗器械 便携式非电驱动输液器具

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

ISO 28620:2010规定了非电动便携式输液器的基本要求和相关试验方法。它适用于设计用于连续（固定或可调节）流量和/或丸状应用的装置。这些设备可用于医疗和非医疗环境。它们可以由医疗保健专业人员或预期患者应用或管理。这些设备可以由制造商预先填充，也可以在医疗专业人员或预期患者使用前填充。

ISO 28620:2010 specifies essential requirements and related test methods for non-electrically driven portable infusion devices. It applies to devices designed for continuous (fixed or adjustable) flow and/or for bolus application.These devices can be used in health care and non-health care settings. They can be applied or administered by 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 the intended patient.

标准预览图