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ISO 11070:2014
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Sterile single-use intravascular introducers, dilators and guidewires
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ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories
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EN 556:1994 + A1:1998
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STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
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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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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 7198:2016
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Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
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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/TR 37137:2014
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Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
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ISO 17475:2005
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Corrosion of metals and alloys Electrochemical test methods Guidelines for conducting potentiostatic and potentiodynamic polarization measurements
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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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ASTM F 3044 : 2014
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Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
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ISO 5840-1:2015
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Cardiovascular implants Cardiac valve prostheses Part 1: General requirements
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ASTM F 3067 : 2014
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Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
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ISO 14630:2012
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Non-active surgical implants General requirements
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ISO/TS 17137:2014
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Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
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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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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 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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ISO 10555-1:2013
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Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
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ASTM F 2942 : 2013
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Standard Guide for <emph type="bdit">in vitro</emph> Axial, Bending, and Torsional Durability Testing of Vascular Stents
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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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ASTM F 2914 : 2012
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Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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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
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ISO 594-2:1998
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Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
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ISO 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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ISO 594-1:1986
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Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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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
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ASTM F 640 : 2012 : REDLINE
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Standard Test Methods for Determining Radiopacity for Medical Use
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ISO 10555-4:2013
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Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
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|
ISO 16429:2004
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Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
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