DIN EN ISO 11608-3:2013-01
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Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
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DIN EN ISO 11608-1:2015-04
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Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
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DIN EN 60601-1-1 : 2002
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
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IEC 60068-2-27:2008
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Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
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IEC 61000-4-1:2006
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Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series
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IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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DIN EN 60068-2-64 : 1995
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ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
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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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IEC 60721-3-7:1995+AMD1:1996 CSV
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Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
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ISO 11608-1:2014
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Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
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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
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IEC 60068-2-64:2008
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Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
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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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ISO 11608-2:2012
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Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
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DIN EN 60721-3-7:1995-09
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CLASSIFICATION OF ENVIRONMENTAL CONDITIONS - PART 3: CLASSIFICATION OF GROUPS OF ENVIRONMENTAL PARAMETERS AND THEIR SEVERITIES - SECTION 7: PORTABLE AND NON-STATIONARY USE
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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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DIN EN 60068-2-27 : 1995
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ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK
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ISO 11608-3:2012
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Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
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IEC 60529:1989+AMD1:1999+AMD2:2013 CSV
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Degrees of protection provided by enclosures (IP Code)
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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 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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VDE 0750-1-1 : 2002
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY; 1 COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
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DIN EN ISO 11608-2:2012-12
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Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
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VDE 0847-4-3 : 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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VDE 0750-1 : 2013
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
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IEC 60601-1-1:2000
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Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
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IEC 60601-1-4:1996+AMD1:1999 CSV
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Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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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)
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