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体外诊断医疗器械.制造商提供的信息(标签).第1部分:术语、定义和一般要求
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
参考页数：49P;A4
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体外诊断医疗器械.制造商提供的信息(标签).第2部分:专业用途的体外诊断试剂
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
参考页数：10P;A4
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用于人体的医疗器械临床研究. 良好的临床实践
Clinical investigation of medical devices for human subjects - Good clinical practice
参考页数：66P.;A4
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医疗器械的生物评定.第10部分:刺激与持续型过敏症试验
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
参考页数：74P.;A4
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医疗器械的生物评定.第17部分:可浸出物质容许限值的确定
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
参考页数：25P;A4
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医疗器械的生物学评价.第18部分:材料的化学特性
Biological evaluation of medical devices - Part 18: Chemical characterization of materials
参考页数：17P;A4
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造口术收集袋 第1部分:词汇 两种语言版
Ostomy collection bags; part 1: vocabulary
参考页数：4P;A4
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医疗器械的生物学评价.第13部分:聚合物医疗器械降解产物的鉴定与定量
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
参考页数：22P.;A4
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医疗器械的生物学评价.第9部分:潜在降解产物的定性与定量总则
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
参考页数：9P;A4
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体外诊断医疗器械.制造商提供的信息(标签).第3部分:专业用体外诊断仪器
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
参考页数：9P;A4
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