ISO 11608-4:2006
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Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
ISO 14253-1:2017
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Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
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 |
ISO 16269-6:2014
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Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals |
IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes |
IEC 61000-4-2:2008
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Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV
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Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 9001:2015
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Quality management systems — Requirements |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
IEC 60601-1-9:2007+AMD1:2013 CSV
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Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
ISO/IEC Guide 98-3:2008
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Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
IEC 60068-2-30:2005
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Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) |