标准编号：ISO 11137-2:2012
中文名称：医疗保健产品灭菌 辐照 第2部分：灭菌剂量的确定
英文名称：Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
发布日期：2012-03
标准范围
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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