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Are the ISO 11607, AAMI and ASTM International standards equally recognized and applied globally? If not, what are the validation standards in these other parts of the world?

Last Updated On May 16, 2008

ISO 11607, also referred to as ISO /EN 11607, is a European norm, as it supports the European Device Directive, and conformance to it is required in the EU. Outside of the EU, the ISO standards take a number of different roles. Within the United States, the FDA has a standard recognition process, which acknowledges the standard and publishes it as such in the Federal Register. Once it has undergone this process, it becomes official guidance of the FDA.

The ISO standards outside of the EU and the United States can be recognized in one of three ways:

• completely as a guidance document, with no official recognition
• as official guidance from a regulatory body within a country
• can be adopted as a requirement just like ISO 11607 in the EU

This depends on the individual country; there is no established pattern. For further information on the regulatory agencies in a specific country, please see Annex A of TIR 22:2007. ASTM and AAMI documents are referenced in and support the work to be accomplished in complying with ISO 11607.