AAMI PC69 : 2007
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EN 60068-2-75:2014
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Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests |
EN 550 : 1994
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
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 |
HD 323.2.17 : 200S4
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BASIC ENVIRONMENTAL TESTING PROCEDURES - TESTS - TEST Q: SEALING |
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 |
HD 323.2.33 : 200S1
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BASIC ENVIRONMENTAL TESTING PROCEDURES - TESTS - GUIDANCE ON CHANGE OF TEMPERATURE TESTS |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
EN 60068-2-64:2008
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ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE |
EN 50061 : 88 AMD 1 95
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SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS |
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 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
|
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
EN 60601-1-2:2015
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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 60068-2-27:2009
|
Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
EN 13185:2001/A1:2003
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NON-DESTRUCTIVE TESTING - LEAK TESTING - TRACER GAS METHOD |
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 |
EN 552:1994/A2:2000
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
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
|
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
IEEE C95.1-2005
|
IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz |
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
EN ISO 14971:2012
|
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
IEC 60068-2-75:2014
|
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
|
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
|
Medical devices Application of risk management to medical devices |
EN 45502-2-1:2003
|
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) |
EN 60118-6:1999
|
Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids |
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) |
EN 554 : 1994
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
IEC 60801-2:1991
|
Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements |
EN 60801-2 : 1993
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ELECTROMAGNETIC COMPATIBILITY FOR INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL EQUIPMENT - PART 2: ELECTROSTATIC DISCHARGE REQUIREMENTS (IEC 801-2:1991) |
EN 60068-2-31:2008
|
ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS |
EN 60068-2-47:2005
|
Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests |
IEC 60068-2-56:1988
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Environmental testing - Part 2: Tests. Test Cb: Damp heat, steady state, primarily for equipment |