内容提示: EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13612:2002/ACDecember 2002Décembre 2002Dezember 2002ICS 11.100English versionVersion FrançaiseDeutsche FassungPerformance evaluation of in vitro diagnostic medical devicesDétermination des performances des dispositifs médicaux pourdiagnostic in ...
2002年 总页数 20页 发布单位 德国标准化学会 当前最新 DIN EN 13612:2002-08 购买 正式版DIN EN 13612:2002-08相似标准AENOR UNE-EN 13612:2002 体外诊断医疗器械的性能评价 AENOR UNE-EN 13612/AC:1970 体外诊断医疗器械的性能评价 UNE-EN 13612/AC:2003 体外诊断医疗器械的性能评价 UNE-EN 13612:2002 ...
UNE-EN 13612/AC:2003相似标准DIN EN 13612:2002-08 体外诊断医疗器械性能评价 GOST R EN 13612-2010 体外诊断医疗器械性能评价 DANSK DS/EN 13612:2002 体外诊断医疗器械性能评价 NF EN 13612:2002 体外诊断医疗器械性能评价 UNI EN 13612:2002 体外诊断医疗器械性能评价 ...
体外诊断试剂IVD欧盟EN13612性能评估部分中英 3 General requirements for the performance evaluation 3.1 Responsibilities and resources The manufacturer takes the responsibility for the initiation and/or the conduct of a performance evaluation study. He shall define the responsibility and the interrelation of ...
EN 13612-2002+AC 体外诊断医疗设备性能评估 Performance evaluation of in vitro diagnostic medical devices EN 13640 体外诊断剂的稳定性试验 Stability testing of in vitro diagnostic reagents EN 13641 消除或减少与体外诊断剂相关的传染风险 Elimination or reduction of risk of infection related to in vitro...
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EN 13612-2002+AC-2002 体外诊断医疗设备性能评估 Performance evaluation of in vitro diagnostic medical devices EN 13640-2002 体外诊断剂的稳定性试验 Stability testing of in vitro diagnostic reagents EN 13641-2002 消除或减少与体外诊断剂相关的传染风险 Elimination or reduction of risk of infection relat...
EN 13612-2002+AC-2002体外诊断医疗设备性能评估Performance evaluation of in vitro diagnostic medical devices EN 13718-1-2002空气、水和困难场所救护车 第1部分:用于患者连续护理的医疗设备借口要求Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity ...
UNE-EN 13612/AC:2003 体外诊断医疗器械的性能评价 UNE-EN 13612:2002 体外诊断医疗器械的性能评价 AENOR UNE-EN 13612/AC:1970 体外诊断医疗器械的性能评价 AENOR UNE-EN 13612:2002 体外诊断医疗器械的性能评价 YY/T 1579-2018 体外诊断医疗器械 体外诊断试剂稳定性评价 ...