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About This Item

 

Full Description

This International Standard identifies symbols conventionally used to convey information essential for proper use to the user and others for safe and effective use of medical devices. This International Standard is primarily intended to be used by:

  • manufacturers of medical devices who market their products in a number of countries having different language requirements for medical device labelling;
  • users of medical devices who draw their supplies from a number of sources and may have varied language capabilities;
  • those responsible for postmarket surveillance;
  • health care regulatory authorities, testing organizations, certification bodies and other organizations responsible for implementing regulations affecting medical devices and having responsibility for postmarket surveillance.

This International Standard may also be of assistance to:

  • manufacturers having to cope with space limitations on small labels;
  • distributors of medical devices or other representatives of manufacturers;
  • health care authorities responsible for training as well as those being trained.
 

Document History

  1. ISO 15223-2:2010


    Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation

    • Most Recent
  2. ISO 15223:2000

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

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 15223/Amd2:2004


    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Amendment 2

  2. ISO 15223/Amd1:2002


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