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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
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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)
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DIN EN 62366 : 2016
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
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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
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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DIN EN 60068-2-6 : 1996
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ENVIRONMENTAL TESTING - PART 2-6: TESTS - TEST FC: VIBRATION (SINUSOIDAL)
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VDE 0750-101 : 2016
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
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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)
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IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices
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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
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VDE 0750-241 : 2016
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
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ISO 16269-6:2014
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Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
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IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes
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DIN ISO 16269-6:2009-10
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STATISTICAL INTERPRETATION OF DATA - PART 6: DETERMINATION OF STATISTICAL TOLERANCE INTERVALS
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IEC 61000-4-2:2008
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Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
|
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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
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DIN EN ISO 9000:2015-11
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QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
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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
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
|
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ISO 9001:2015
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Quality management systems — Requirements
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|
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)
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|
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary
|
|
DIN EN 62304 : 2016
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
|
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices
|
|
DIN EN 61000-4-2 : 2009
|
ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-2: TESTING AND MEASUREMENT TECHNIQUES - ELECTROSTATIC DISCHARGE IMMUNITY TEST
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|
DIN EN ISO 9001 E : 1994
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QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING
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IEC 60601-1-9:2007+AMD1:2013 CSV
|
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
|
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)
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|
ISO/IEC Guide 98-3:2008
|
Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
|
|
IEC 60068-2-30:2005
|
Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)
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