|
医疗设备的生物学评定.第16部分:降解产物和可溶出物的毒代动力学研究设计(ISO 10993-16-2017);德文版本EN ISO 10993-16-2017
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
参考页数：26P.;A4
|
|
|
|
|
|
医疗器械.质量管理系统.管理目标的要求
Medical devices -- Quality management systems -- Requirements for regulatory purposes
参考页数：44P;A4
|
|
|
|
|
|
进出口医疗器械检验规程第3部分:人体血液及血液成分袋式塑料容器 传统型血袋
参考页数：8P.;A4
|
|
|
|
|
|
结核分枝杆菌耐药基因芯片检测基本要求
General requirements of DNA array-based M. tuberculosis drug resistance detection
参考页数：7P.;A4
|
|
|
|
|
|
包含医疗设备IT网络的风险管理应用. 应用指南. 分布式报警系统指南
Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance on distributed alarm systems
参考页数：42P.;A4
|
|
|
|
|
|
包含医疗设备IT网络的风险管理应用. 应用指南. 责任协议指南
Application of risk management for IT-networks incorporating medical device. Application guidance. Guidance for responsibility agreements
参考页数：26P.;A4
|
|
|
|
|
|
医疗车辆及其设备.空中救护机.用于空中救护机的医疗装置要求
Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances
参考页数：22P.;A4
|
|
|
|
|
|
医疗器械的生物学评价.第3部分:遗传毒性,致癌性和生殖毒性试验
Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
参考页数：48P.;A4
|
|
|
|
|
|
医疗器械的生物评定.刺激与皮肤过敏症试验
Biological evaluation of medical devices. Tests for irritation and skin sensitization
参考页数：80P.;A4
|
|
|
|
|
|
实施医疗器械用ISO 13485质量管理体系
Implementing an ISO 13485 Quality Management System for Medical Devices
参考页数：196P.;A4
|
|
|
|
|
