ISO 11137-2-2006 保健产品的灭菌.辐射.第2部分:确定杀菌剂量

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                   【英文标准名称】:     Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose            【原文标准名称】:     保健产品的灭菌.辐射.第2部分:确定杀菌剂量            【标准号】:     ISO 11137-2-2006            【标准状态】:     现行            【国别】:     国际            【发布日期】:     2006-04    【实施或试行日期】: 【发布单位】: 国际标准化组织(IX-ISO)【起草单位】: ISO/TC 198【标准类型】: ()【标准水平】: ()【中文主题词】: 定义;剂量;效率;电子束;杀菌剂;保健;卫生学;检验;电离辐射;辐照器;医疗设备;医疗产品;医学科学;医疗技术学;方法;产品信息;公共卫生;质量管理;辐射;辐射剂量;射线处理;规范(验收);辐射灭菌;灭菌;监督(认可);验证;X射线【英文主题词】: Acceptance (approval);Biological hazards;Calibration;Checks;Clearing;Containers;Definitions;Dose;Dosimeters;Dosimetry;Efficiency;Elections;Electron beams;Evaluations;Gamma-radiation;Germicides;Guide books;Health protection;Hygiene;Inspection;Ionizing radiation;Irradiation apparatus;Jets;Maintenance;Medical devices;Medical equipment;Medical products;Medical sciences;Medical technology;Methodserformanceersonnelhototherapylantroduct informationublic health;Qualifications;Quality management;Radiation;Radiation dose;Ray treatment;Routine tests;Specification (approval);Sterilization by irradiation;Sterilization (hygiene);Surveillance (approval);Validation;Verification;X-rays【摘要】: 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.【中国标准分类号】: C04【国际标准分类号】: 11_080_01【页数】: 60P;A4【正文语种】: 英语