发明申请
US20150320640A1 Method of Manufacturing a Medical Device 审中-公开
制造医疗器械的方法

  • 专利标题: Method of Manufacturing a Medical Device
  • 专利标题(中): 制造医疗器械的方法
  • 申请号: US14409127
    申请日: 2013-07-02
  • 公开(公告)号: US20150320640A1
    公开(公告)日: 2015-11-12
  • 发明人: Ulla Holm Christensen
  • 申请人: Novo Nordisk Healthcare AG
  • 优先权: EP12174592.1 20120702
  • 国际申请: PCT/EP2013/063894 WO 20130702
  • 主分类号: A61J1/20
  • IPC分类号: A61J1/20 B65B55/02 B65B3/00
Method of Manufacturing a Medical Device
摘要:
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.
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