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医疗器械和医疗系统. 以患者为中心综合医疗环境(ICE)组成设备的基本安全要求. 第1部分: 一般要求和概念模型
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
参考页数：39P.;A4
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医疗器械材料直接接触细胞培养评价的标准实施规程
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
参考页数：5P.;A4
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组织工程医疗产品(TEMPs)中附加剂评定的标准指南
Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
参考页数：9P.;A4
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医用面罩用材料性能的标准规格
Standard Specification for Performance of Materials Used in Medical Face Masks
参考页数：4P.;A4
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医疗器械材料直接接触细胞培养评价的标准实施规程
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
参考页数：5P.;A4
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医疗装置.医疗装置风险管理的应用
Medical devices - Application of risk management to medical devices
参考页数：82P;A4
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医疗器械.不良事件的层级编码结构.第1部分:事件类型编码.修改件1
Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes; Amendment 1
参考页数：7P;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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医疗设备.医疗设备.不良事件的层级编码结构.第1部分:评估编码
Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
参考页数：13P;A4
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医疗设备.医疗设备.不良事件的层级编码结构.第1部分:事件类型编码
Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
参考页数：22P.;A4
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