ISO 10993-4:2017
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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
IEC 60068-1:2013
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Environmental testing - Part 1: General and guidance |
IEC 60068-2-27:2008
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Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
ISO 14155-2:2003
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Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
ISO 5840:2005
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Cardiovascular implants Cardiac valve prostheses |
ISO 7198:2016
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Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
ISO 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements |
IEC 60601-1-8:2006+AMD1:2012 CSV
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Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
IEC 60068-2-64:2008
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Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices |
IEC 60601-1-2:2014
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes |
IEC 60300-3-2:2004
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Dependability management - Part 3-2: Application guide - Collection of dependability data from the field |
IEC TR 60878:2015
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Graphical symbols for electrical equipment in medical practice |
ISO 14708-1:2014
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Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 5198:1987
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Centrifugal, mixed flow and axial pumps Code for hydraulic performance tests Precision grade |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |