标准编号：ISO 11137-2:2006
中文名称：健保产品的消毒 放射线-第2部分： 确定消毒剂量
英文名称：Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
发布日期：2006-04
标准范围
This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specifiedrequirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose toachieve a sterility assurance level, SAL, of 10–6. This part of ISO 11137 also specifies methods of doseauditing in order to demonstrate the continued effectiveness of the sterilization dose.This part of ISO 11137 defines product families for dose establishment and dose auditing.
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