DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
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 |
VDE 0750-1-2 : 2016
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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 60601-1-2:2014) |
DIN EN ISO 14253-1:2013-12
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GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - INSPECTION BY MEASUREMENT OF WORKPIECES AND MEASURING EQUIPMENT - PART 1: DECISION RULES FOR PROVING CONFORMITY OR NONCONFORMITY WITH SPECIFICATIONS (ISO 14253-1:2013) |
DIN EN 62366 : 2016
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
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 |
DIN EN 60068-2-6 : 1996
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ENVIRONMENTAL TESTING - PART 2-6: TESTS - TEST FC: VIBRATION (SINUSOIDAL) |
VDE 0750-101 : 2016
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
DIN EN 60068-2-30:2006-06
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ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE) |
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 |
VDE 0750-241 : 2016
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
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 |
DIN ISO 16269-6:2009-10
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STATISTICAL INTERPRETATION OF DATA - PART 6: DETERMINATION OF STATISTICAL TOLERANCE INTERVALS |
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 |
DIN EN ISO 9000:2015-11
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QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
DIN EN 61000-4-3 : 2011
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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 |
DIN EN 60601-1-9 : 2014
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007 + A1:2013) |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
DIN EN ISO 9001:2015-11
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QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
DIN EN 62304 : 2016
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
DIN EN 61000-4-2 : 2009
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ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-2: TESTING AND MEASUREMENT TECHNIQUES - ELECTROSTATIC DISCHARGE IMMUNITY TEST |
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 |
DIN EN 60601-1-11 : 2016
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015) |
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) |