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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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ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
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EN ISO 11608-3:2012
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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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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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EN ISO 11608-2:2012
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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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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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ISO 7886-1:2017
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Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
|
IEC 61000-4-2:2008
|
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
|
Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
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EN ISO 11608-1:2015
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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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ISO 11134:1994
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Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
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EN ISO 14155-2:2009
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Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
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ISO 11137:1995
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Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
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EN ISO 14155-1:2009
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Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
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EN ISO 10993-1:2009/AC:2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010) |
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ISO 15223:2000
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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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) |