欧盟医疗器械灭菌产品要求的标准清单 .pdf

EN无菌标准清单

No.StandardNo.Ver.Name

Sterilization-Steamsterilizers-Largesterilizers灭菌-

1EN2852006+A2:2009

蒸汽灭菌器-大型灭菌器

Sterilizationofmedicaldevices-Requirementsfor

ENmedicaldevicestobedesignatedSTERILE-Part1:

2556-1/YY/T0615.2001/AC:2006Requirementsforterminallysterilizedmedicaldevices

1医疗设备的灭菌拟被认定为无菌的医疗设备的要求第

1部分:对最终灭菌设备的要求

Sterilizationofmedicaldevices-Requirementsfor

medicaldevicestobedesignatedSTERILE-Part2:

EN556-2/

32003Requirementsforasepticallyprocessedmedical

YY/T0615.2

devices医疗设备的灭菌拟被认定为无菌的医疗设备的

要求第1部分:无菌加工医疗器械的要求

Packagingforterminallysterilizedmedicaldevices-

ENISO

Part1:Requirementsformaterials,sterilebarrier

411607-1(ISO2009

systemsandpackagingsystems最终灭菌医疗器械的

11607-1:2006)

包装第1部分:材料、灭菌隔层和包装系统的要求

Packagingforterminallysterilizedmedicaldevices-

ENISO11607-2

Part2:Validationrequirementsforforming,sealing

5(ISO2006

andassemblyprocesses最终灭菌医疗器械的包装

11607-2:2006)

第2部分成形、密封和装配过程的确认要求

Sterilization