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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 |
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ISO 14160:2011
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Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
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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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MEDDEV 2.12-1 : REV 8 : 2013
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GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM |
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EN 12006-2:1998+A1:2009
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Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
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ISO 21534:2007
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Non-active surgical implants Joint replacement implants Particular requirements |
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ISO 5840:2005
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Cardiovascular implants Cardiac valve prostheses |
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ASTM F 2503 : 2013 : REDLINE
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Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
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ISO 14937:2009
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Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
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IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV
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Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
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ISO 21536:2007
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Non-active surgical implants Joint replacement implants Specific requirements for knee-joint replacement implants |
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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 |
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ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
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ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
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ISO/TR 14283:2004
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Implants for surgery Fundamental principles |
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ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards |
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ISO 14602:2010
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Non-active surgical implants — Implants for osteosynthesis — Particular requirements |
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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 |
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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 |
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ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants General requirements |
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ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times |
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ISO 13408-1:2008
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Aseptic processing of health care products Part 1: General requirements |
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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 |
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ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
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ISO 11137-2:2013
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Sterilization of health care products Radiation Part 2: Establishing the sterilization dose |
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
|
ISO 25539-3:2011
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Cardiovascular implants Endovascular devices Part 3: Vena cava filters |
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ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice |
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ISO 22442-3:2007
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Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
|
ISO 7197:2006
|
Neurosurgical implants Sterile, single-use hydrocephalus shunts and components |
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ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
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ISO 7000:2014
|
Graphical symbols for use on equipment Registered symbols |
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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 |
|
ISO 14607:2007
|
Non-active surgical implants Mammary implants Particular requirements |
|
ISO 17664:2017
|
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
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ISO 12891-1:2015
|
Retrieval and analysis of surgical implants Part 1: Retrieval and handling |
|
ISO 21535:2007
|
Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants |
|
ISO 17665-1:2006
|
Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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ISO 16429:2004
|
Implants for surgery Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods |