DS/EN 556-1995
医疗器械的消毒．标上“已消毒”标签的医疗器械的要求已作废

Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

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标准号

DS/EN 556-1995

发布日期

1995年01月10日

实施日期

废止日期

无

发布单位

丹麦标准化协会

适用范围

1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled 'STERILE'. NOTE. For the purposes of the EC Directives for medical devices and for active implantable medical devices (see annex A), labelling a medical device 'STERILE' is only permissible when a validated sterilization process has been used. Requirements for the validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552 and EN 554. 2 This European Standard is not applicable to in vitro diagnostic medical devices.

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