標準號：ISO 28620-2010
中文標準名稱：醫療設備.非電驅動的便攜式輸液設備
英文標準名稱：Medical devices - Non-electrically driven portable infusion devices
標準類型：C30
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C30
國際標準分類號：11.040.20
引用標準：ISO 594-1;ISO 594-2;ISO 10993;ISO 15223-1
適用范圍：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.