Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing; German version EN 376:2002, German and English texts— 19 стр.
Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007, Corrigenda to DIN EN ISO 14971:2007-07— 2 стр.
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003); German version EN ISO 15197:2003, text German and English— 84 стр.