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ISO 13485

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Document title: ISO 13485 - Medical devices -- Quality management systems -- Requirements for regulatory purposes


Where compliance with a quality system is required under the medical devices directives, the quality system standards applied currently are either IS EN ISO 13485/88:2000 or ISO 13485:2003

Formerly, the EN 46000 series standards were the set of European harmonised standards developed to meet the specific requirements for quality systems for medical device manufacturers under the medical device directives. These were not stand-alone standards and were meant to be used in conjunction with the ISO 9000:1994 series. The ISO 9000:1994 series became obsolete in December 2003. The 46000 series become obsolete in February 2004.

ISO 13485 and ISO 13488 are the international standards that are similar to EN 46000 but do contain some additional requirements. Note: The IS EN ISO 13485/88:2000 will become obsolete by July 2006.

ISO 13485:2003 is a Quality Management System for medical devices, specifically for regulatory purposes. It is based on EN ISO 9001:2000 with some modifications. Both IS EN ISO 13485/88:2000 and EN ISO 13485:2003 are harmonised standards so either can be used to demonstrate compliance to quality system requirements under the medical device directives.