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ISO 11202:2010
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Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections |
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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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ISO 14155-2:2003
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Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
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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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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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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 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements |
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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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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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ISO 7886-1:2017
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Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
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ISO 3746:2010
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Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
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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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ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
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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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ISO 11137:1995
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Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
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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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ISO 11201:2010
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Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections |
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ISO 11204:2010
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Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions applying accurate environmental corrections |
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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) |
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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) |