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保健品消毒.干热.医疗器材消毒步骤的制定,确认和常规控制要求
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
参考页数：58P;A4
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医疗设备的生物评定.第19部分:材料的物理化学、形态学和地形学特点
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
参考页数：15P.;A4
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终端无菌医学设备的包装.第2部分:组成、密封和装配过程的确认要求
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
参考页数：11P;A4
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终端无菌医学设备的包装.第1部分:材料、消毒阻挡系统和包装系统的要求
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
参考页数：24P;A4
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医疗设备辅助用轨道系统
Rail systems for supporting medical equipment
参考页数：21P;A4
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外科器械 剪刀和大剪刀 一般要求和试验方法
Instruments for surgery; Scissors and shears; General requirements and test methods
参考页数：3P.;A4
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体外诊断医疗装置.生物试样的定量测量.校准仪和控制材料赋值的计量溯源性
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
参考页数：26P.;A4
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医疗设备的生物评定.第20部分:医疗设备的免疫毒物学试验的原则和方法
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
参考页数：17P.;A4
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尿收集袋 第2部分:要求和试验方法
Urine collection bags - Part 2: Requirements and test methods
参考页数：15P.;A4
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造口术收集袋 第2部分:要求和试验方法
Ostomy collection bags - Part 2: Requirements and test methods
参考页数：8P;A4
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