標準號：BS EN ISO 11607-2-2006
中文標準名稱：終端無菌醫學設備的包裝.組成、密封和裝配過程的確認要求
英文標準名稱：Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
標準類型：C47
發布日期：2006/5/31 12:00:00
實施日期：2006/4/1 12:00:00
中國標準分類號：C47
國際標準分類號：11.080.30
適用范圍：ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.