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医疗设备.质量管理.医疗设备命名法数据结构
Medical devices - Quality management - Medical device nomenclature data structure
参考页数：13P.;A4
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医疗器械的生物学评价. 第33部分: 基因毒性评估试验指南. ISO 10993-3的补充件
Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
参考页数：47P.;A4
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医疗器械的生物学评估.第16部分:降解产物和可滤取物的毒物动力学研究设计
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
参考页数：13P.;A4
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医疗器械的生物评定.第3部分:遗传毒性、致癌性和生殖毒性的试验
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
参考页数：34P.;A4
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医疗器械的心血管生物学评价. 可吸收性植入物指南
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
参考页数：17P.;A4
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终端无菌医疗器械的包装. ISO 11607-1和ISO 11607-2应用指南
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
参考页数：115P.;A4
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终端无菌医疗器械的包装. 第2部分: 成型, 密封和装配工艺的验证要求; 修改件1
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes; Amendment 1
参考页数：2P.;A4
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终端无菌医疗器械的包装. 第1部分: 材料, 无菌屏障系统和包装系统要求; 修改件1
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems; Amendment 1
参考页数：11P.;A4
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一次性使用的无菌管内导管, 扩张器和导丝
Sterile single-use intravascular introducers, dilators and guidewires
参考页数：26P.;A4
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医用肺通气机.第4部分:操作员控制的呼吸器的特殊要求
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators
参考页数：22P;A4
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