标准号:ISO 28620-2010
中文标准名称:医疗设备.非电驱动的便携式输液设备
英文标准名称:Medical devices - Non-electrically driven portable infusion devices
标准类型:C30
发布日期:1999/12/31 12:00:00
实施日期:1999/12/31 12:00:00
中国标准分类号:C30
国际标准分类号:11.040.20
引用标准:ISO 594-1;ISO 594-2;ISO 10993;ISO 15223-1
适用范围: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.