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Austria updates medical implant standard:

This article was originally published in Clinica

Executive Summary

Austria last week introduced a new standard for implantable medical devices. The ONORM EN ISO 16054 is aimed at easing difficulties in international data exchange, to improve the registration and traceability of implanted devices, and the analysis of extracted devices. In addition, the minimum requirements contained in the standard should also make recalls easier, says the Austrian Standards Institute (ON). The standard is directed at manufacturers and users of permanent medical implants - those in use for over 30 days - and at hospitals and other medical institutions that carry out implantation.

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