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About This Item

 

Full Description

This part of ISO 15223 addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required to appear with the medical device in most regulatory domains. The information can be required to appear on the medical device itself, as part of the label, or provided with the medical device.
 

Document History

  1. AAMI/ISO 15223-1:2016


    Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements

    • Most Recent
  2. AAMI/ISO 15223-1:2012

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    Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements

    • Historical Version
  3. AAMI/ISO 15223-1:2007/(R)2012


    Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements (Includes 15223-1:2007/A1:2008)

    • Historical Version
  4. AAMI/ISO 15223:2000 + Amendments 1 and 2


    Medical devices-Symbols to be used with medical device labels, labeling,and information to be supplied.

    • Historical Version
  5. AAMI/ISO 15223:2000 + Amendment 1


    Amendment 1 - Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

    • Historical Version
  6. AAMI/ISO 15223-2000


    Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied - Includes Amendment 1, dated September 24, 2001

    • Historical Version