DIN EN ISO 14971 [Withdrawn] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 18113-1 | 2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 More |
| DIN EN ISO 18153 | 2003-11 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003 More |
| DIN EN ISO 22442-3 | 2008-03 | 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 More |
| IEC 60601-1 | 2005-12 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More |
| IEC 60601-1-6 | 2010-01 | Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability More |
| IEC 60601-1-8 | 2006-10 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems More |
| IEC 61025 | 2006-12 | Fault tree analysis (FTA) More |
| IEC/TR3 60513 | 1994-01 | Fundamental aspects of safety standards for medical electrical equipment More |
| ISO 15198 | 2004-07 | Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer More |
| ISO 18153 | 2003-08 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials More |
