Understanding the Versions of ISO 13485

This note describes two of the many versions of ISO 13485. The first path describes ISO 13485, while the second path describes EN ISO 13485.

The ISO Path

In 2003, ISO issued ISO 13485:2003. This standard provides particular requirements for medical devices, using ISO 9001:2000 as a basis.

Subsequently, ISO issued ISO 9001:2008 to replace ISO 9001:2000.

ISO then issued ISO 13485:2003, Cor. 1 to correct some references in ISO 13485:2003. These references cite ISO 9001 without citing the version. The corrigendum clarifies the references to ISO 9001:2000.

The CEN Path

CEN issued EN ISO 13485:2003 as a European Norm. Eventually it became harmonized to the MDD, IVDD, and AIMDD.

CEN needed to replace EN 46003 and add references to Module E in several places. These modules define the conformity paths applied by the new approach directives. This change didn’t have any impact on manufacturers. The change became EN ISO 13485:2003/AC 2007.

CEN incorporated ISO 13485:2003 Cor. 1 and EN ISO 13485:2003/AC 2007 into EN ISO 13485:2003/AC 2009. This version is harmonized to the MDD, IVDD, and AIMDD.