Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN ISO 11607-2:2020
• Năm ban hành / Publication date: 2020
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
• Phạm vi áp dụng / Scope of standard: This document specifies requirements for the 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. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.