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医疗器械与血小板相互作用试验 第1部分:体外血小板计数法
参考页数：8
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医疗器械遗传毒性试验 第2部分:体外哺乳动物细胞染色体畸变试验
参考页数：17
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医疗设备的生物评估.第4部分:血统相互作用试验筛选
Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood
参考页数：86P.;A4
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医疗器械的生物学评价. 第11部分: 全身毒性试验
Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
参考页数：46P.;A4
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静电学. 第6-1部分: 医疗用静电控制. 设备的一般要求
Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for facilities
参考页数：45P.;A4
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关于EN ISO 13485:2016(医疗器械,质量管理体系,监管要求)和欧洲医疗器械法规和体外诊断医疗器械法规之间关系的指导
Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
参考页数：88P.;A4
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声学.音响设备校正基准零点.纯音和超听觉耳机用基准等效阈值声压级
Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold sound pressure levels for pure tones and supra-aural earphones
参考页数：18P.;A4
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药品的主要包装材料.以良好加工实践(GMP)为参考ISO 9001-2015应用的特殊要求(ISO 15378-2017);德文版本EN ISO 15378-2017
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
参考页数：105P.;A4
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药品的主要包装材料.以良好加工实践(GMP)为参考ISO 9001-2015应用的特殊要求(ISO 15378-2017);德文版本EN ISO 15378-2017
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
参考页数：105P.;A4
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医用电气设备. 第1-8部分: 基本安全和基本性能的一般要求. 附带标准: 医用电气设备和医用电气系统中警报系统的一般要求、试验和指南
Medical electrical equipment - Part 1-8 : general requirements for basic safety and essential performance - Collateral Standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
参考页数：9P.;A4
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