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This Technical Specification describes approaches to the selection and auditing of a sterilization dose that economize in relation to the number
Sterilization of health care products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
This Technical Specification describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
Medical products. Radiation sterilization. Dosimetric techniques
本标准提供了评价医疗保健产品(包括包装)的组成材料,包括高分子材料、金属、陶瓷/玻璃及其他材料对辐射灭菌加工的适宜性的程序和信息,为选择和鉴定医疗保健产品和包装的材料提供指南
Evaluation of materials of health care product subject to radiation sterilization
Medical products. Dosimetric techniques for radiation sterilization
Sterilization of health care Products. Radiation. Establishing the sterilization dose
GB 18280的本部分规定了用于满足菌特殊要求的最小剂量的设定方法和证实25 kGy或15 kGy作为能达到10-6菌保证水平(SAL)的灭菌剂量的方法。本部分还规定了剂量审核的方法，以便证明灭菌剂量持续有效。 本部分定义了用于剂量建立和剂量审核的产品族
Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
Sterilization of health care products. Radiation. Establishing the sterilization dose
Sterilization of health care products. Radiation. Establishing the sterilization dose
Sterilization of health care products. Radiation. Establishing the sterilization dose
本标准结构包括前言、引言、六个章节和两个资料性附录。 六个章节中的前两章系“范围”和“规范性引用文件”。 第三至第六章系本标准的具体内容。标准具体内容包括术语和定义；剂量设定、剂量证实和灭菌剂量审核中产品族的定义和保持；建立和验证灭菌剂量中产品的选择和试验；剂量建立的方法。 附录A为资料性附录
Guidance on radiation sterilization of tissue-based biologics and tissue-derived products
Im vorliegenden Teil von ISO 11137 werden Verfahren zur Ermittlung der Mindestdosis, die zur Erfüllung einer festgelegten Anforderung an die Sterilit
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
This Technical Specification describes approaches to the selection and auditing of a sterilization dose that economize in relation to the number
Sterilization of health care products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
This Technical Specification describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
Medical products. Radiation sterilization. Dosimetric techniques
本标准提供了评价医疗保健产品(包括包装)的组成材料,包括高分子材料、金属、陶瓷/玻璃及其他材料对辐射灭菌加工的适宜性的程序和信息,为选择和鉴定医疗保健产品和包装的材料提供指南
Evaluation of materials of health care product subject to radiation sterilization
Medical products. Dosimetric techniques for radiation sterilization
Sterilization of health care Products. Radiation. Establishing the sterilization dose
GB 18280的本部分规定了用于满足菌特殊要求的最小剂量的设定方法和证实25 kGy或15 kGy作为能达到10-6菌保证水平(SAL)的灭菌剂量的方法。本部分还规定了剂量审核的方法，以便证明灭菌剂量持续有效。 本部分定义了用于剂量建立和剂量审核的产品族
Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose
Sterilization of health care products. Radiation. Establishing the sterilization dose
Sterilization of health care products. Radiation. Establishing the sterilization dose
Sterilization of health care products. Radiation. Establishing the sterilization dose
本标准结构包括前言、引言、六个章节和两个资料性附录。 六个章节中的前两章系“范围”和“规范性引用文件”。 第三至第六章系本标准的具体内容。标准具体内容包括术语和定义；剂量设定、剂量证实和灭菌剂量审核中产品族的定义和保持；建立和验证灭菌剂量中产品的选择和试验；剂量建立的方法。 附录A为资料性附录
Guidance on radiation sterilization of tissue-based biologics and tissue-derived products
Im vorliegenden Teil von ISO 11137 werden Verfahren zur Ermittlung der Mindestdosis, die zur Erfüllung einer festgelegten Anforderung an die Sterilit
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
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