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ISO 15223:2000

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

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.


Content Provider
International Organization for Standardization [iso]


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Document History
Revises:
  • ISO/TR 15223:1998
Revised By:
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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