ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
MIL-STD-883 Revision K:2016
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TEST METHOD STANDARD - MICROCIRCUITS |
IEC 60068-2-27:2008
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Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
IEC 60118-6:1999
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Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids |
EN 1593:1999/A1:2003
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NON-DESTRUCTIVE TESTING - LEAK TESTING - BUBBLE EMISSION TECHNIQUES |
IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
IEC 60068-2-31:2008
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Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens |
IEC 60068-2-64:2008
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Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
ISO 14117:2012
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Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
ISO 5841-2:2014
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Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads |
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 |
EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
EN 13185:2001/A1:2003
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NON-DESTRUCTIVE TESTING - LEAK TESTING - TRACER GAS METHOD |
IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes |
ASTM F 2052 : 2015 : REDLINE
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Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
IEC 60068-2-47:2005
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Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests |
ISO 14708-2:2012
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Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
IEC 60068-2-17:1994
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Basic environmental testing procedures - Part 2-17: Tests - Test Q: Sealing |
EN 45502-1:2015
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IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
ASTM F 2213 : 2017 : REDLINE
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Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
IEC 61000-4-2:2008
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Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
IEEE C95.1-2005
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IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz |
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice |
IEC 60068-2-75:2014
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Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests |
CISPR 11:2015 RLV
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Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
EN 45502-1 : 2015
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IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
IEC 60068-2-14:2009
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Environmental testing - Part 2-14: Tests - Test N: Change of temperature |
EN 45502-2-3:2010
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Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
ISO 17665-1:2006
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Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |