Tiêu chuẩn quốc tế
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Số hiệu
Standard Number
EN ISO 11607-2:2006
Năm ban hành 2006
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
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Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard This part of ISO 11607 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.
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