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评估手术前, 导管插入术前或注射前皮肤处理的标准试验方法
Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
参考页数:6P.;A4
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采用模拟使用试验测定可重复使用医疗器械消毒过程有效性的标准试验方法
Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
参考页数:5P.;A4
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保健品灭菌. 词汇. 灭菌及相关设备和工艺标准中使用的术语(ISO 11139-2018); 德文和英文版本EN ISO 11139-2018
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018); German and English version EN ISO 11139:2018
参考页数:91P.;A4
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保健产品的无菌加工.第7部分:医疗器械和组合产品用可替代工艺
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
参考页数:19P;A4
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保健产品的无菌加工.第6部分:隔离器系统
Aseptic processing of health care products - Part 6: Isolator systems
参考页数:17P;A4
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保健品的无菌加工. 第1部分: 一般要求. 修改件1
Aseptic processing of health care products - Part 1: General requirements; Amendment 1
参考页数:10P.;A4
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保健产品的无菌加工.第5部分:现场消毒
Aseptic processing of health care products - Part 5: Sterilization in place
参考页数:14P;A4
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卫生保健产品的无菌工艺.第3部分:冻干法
Aseptic processing of health care products - Part 3: Lyophilization
参考页数:11P;A4
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保健产品的无菌加工.第4部分:就地清洗技术
Aseptic processing of health care products - Part 4: Clean-in-place technologies
参考页数:14P;A4
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医疗保健产品的无菌加工.第1部分:一般要求
Aseptic processing of health care products - Part 1: General requirements
参考页数:54P.;A4
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