Tiêu chuẩn quốc tế
Số hiệu
Standard Number
EN ISO 13408-7:2015
Năm ban hành 2015
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
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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 13408 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied. This part of ISO 13408 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.
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