Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2003— 30 стр.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2003— 15 стр.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009— 17 стр.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009— 103 стр.
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2009— 32 стр.
Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents; German version EN 14299:2004— 36 стр.
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007— 31 стр.
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004); German version EN ISO 22803:2005— 14 стр.
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007); German version EN ISO 22794:2007— 16 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); German version EN ISO 10993-10:2009— 68 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002); German version EN ISO 10993-10:2002— 55 стр.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2003— 15 стр.
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2009— 32 стр.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009— 103 стр.