DIN EN ISO 13485

The DIN EN ISO 13485 clarifies the requirements for a comprehensive management system for the design and manufacture of medical devices.

The current edition was published in 2003 and replaces previous documents such as the EN 46001, EN 46002 ( (both from 1997), the ISO 13485, which was published in 1996, and the ISO 13488.

Since 2004 WALTHER-PRÄZISION is certified in accordance with this standard for the scope "Design/Development and Sales of mono and multi-couplings, hose/plug/ and connector systems for medical applications".