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    • 88. 发明申请
    • METHOD OF MANUFACTURING A MEDICAL DEVICE
    • 制造医疗器械的方法
    • WO2014006021A1
    • 2014-01-09
    • PCT/EP2013/063894
    • 2013-07-02
    • NOVO NORDISK HEALTH CARE AG
    • CHRISTENSEN, Ulla Holm
    • A61M5/00A61J1/20B65B55/02B65B3/00
    • A61J1/2048A61J1/201A61J1/2089A61J1/2096A61M5/002A61M2207/00B65B3/003B65B55/027F04C2270/0421Y10T29/49828
    • The invention relates to a method of manufacturing a medical device (1, 299, 399), the method comprising: (i) receiving in a first cleanroom environment categorised by a first airborne particulate cleanliness a plurality of medical components (10, 20, 50, 50', 210, 220, 320, 350) prepared in a second cleanroom environment categorised by a second airborne particulate cleanliness, which is higher than the first airborne particulate cleanliness, where each of the plurality of medical components (10, 20, 50, 50', 210, 220, 320, 350) comprises a sealed surface portion, (ii) assembling at least the plurality of medical components (10, 20, 50, 50', 210, 220, 320, 350) in the first cleanroom environment, thereby providing a sub-assembly, and (iii) establishing an enclosure for the sub-assembly capable of maintaining an internal airborne particulate cleanliness equivalent to the first airborne particulate cleanliness.
    • 本发明涉及一种制造医疗装置的方法,该方法包括:(i)在由第一空气中的颗粒清洁度分类的第一洁净室环境中接纳多个医疗部件(10,20,50) ,50',210,220,320,350),其被制备在由第二空气中的颗粒清洁度分类的第二洁净室环境中,所述第二空气中的颗粒清洁度高于所述第一空气中的颗粒清洁度,其中所述多个医疗部件(10,20,50 ,50',210,220,320,350)包括密封表面部分,(ii)将至少所述多个医疗部件(10,20,50,50',210,220,320,350)组装在所述第一 洁净室环境,从而提供子组件,以及(iii)建立能够保持与第一空气中的颗粒清洁度相当的内部空气中的颗粒清洁度的子组件的外壳。