標準號：BS EN ISO 11607-1-2009
中文標準名稱：終端無菌醫學設備的包裝.材料、無菌屏障系統和包裝系統的要求
英文標準名稱：Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
標準類型：C47
發布日期：2010/2/28 12:00:00
實施日期：2010/2/28 12:00:00
中國標準分類號：C47
國際標準分類號：11.080.30
引用標準：ISO 5636-5-2003
適用范圍：This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barriersystems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminallysterilized medical devices until the point of use.This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices areplaced in sterile barrier systems and sterilized.This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems formedical devices that are manufactured aseptically. Additional requirements might also be necessary fordrug/device combinations.