Tiêu chuẩn quốc tế
Số hiệu
Standard Number
EN ISO 11137-2:2015
Năm ban hành 2015
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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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 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.
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