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Medical device labeling

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Medical device labeling

  1. 1. MEDICAL DEVICE LABELING Malesh M www.i3cglobal.com
  2. 2. www.i3cglobal.com MEDICAL DEVICE LABELING All labels must be designed and applied to devices and containers so that the labels will remain in place and legible during the customary conditions of distribution, storage, and use. Likewise, other labeling, such as user instructions, should remain legible during customary storage and use. Labeling materials, including preprinted containers, inserts and preprinted packaging materials, must be stored in an area and manner suitable to prevent mix ups Labeling should be identified and segregated to the degree necessary to prevent mixing of similar labeling. The label should be clear and easily traceable.
  3. 3. www.i3cglobal.com Storage control should be appropriate for the number and kind of Medical Device. Special attention should be given to the labeling of sterile devices and must be labeled to properly inform users what is actually intended to be “sterile” in the package. When we apply for CE Making for Medical Device we have to prepare the labels as per ISO 15223:2012. ISO 15223:2012 represents a significant advancement in the safety and effective use of symbols .The earlier version, EN 980 is substituted with ISO 15223:2012

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