MDD协调标准.docVIP

93/42/EEC协调标准 标准代号 标准英文名称 标准中文名称 被替代的标准 对应的国内标准 EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers 消毒 蒸气消毒 大型消毒设备 EN 285:1996 EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use 由生产商提供的专业用活体外诊断试剂的信息 　 EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing 生产者在实验室中用自检测诊断试剂提供信息 　 EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes 医疗专用手套.防洞要求和试验 EN 455-1:1993 EN 455-2:2000 Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996) 医疗专用手套.物理性能要求和试验 EN 455-2:1995 EN 455-3:2006 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation 医疗专用手套.生物评价的要求和试验 EN 455-3:1999 EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devicesEN 556-1:2001/AC:2006 医疗设备的灭菌.拟被认定为无菌的医疗设备的要求.对最终灭菌设备的要求 EN 556:1994 + A1:1998 EN 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices 医疗器械的消毒 标明为“消过毒”的医疗器械的要求 第2部分：消毒处理的医疗器械的要求 　 EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use 专用试管诊断仪的使用说明 　 EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing 实验室条件下自测试诊断仪的使用说明 　 EN 737-1:1998 Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum 医疗气体管道系统.压缩医疗气体用终端设备和真空终端设备 EN 737-4:1998 Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems 医疗气体管道系统.麻醉气体净化系统的终端设备 　 EN 738-4:1998 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipmentEN 738-4:1998/A1:2002 医用气体用