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ISO 11070:2014
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Sterile single-use intravascular introducers, dilators and guidewires |
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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 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
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ISO 10555-2:1996
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Sterile, single-use intravascular catheters Part 2: Angiographic catheters |
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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 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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ISO/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
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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 14630:2012
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Non-active surgical implants General 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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ISO/TS 15539:2000
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Cardiovascular implants Endovascular prostheses |
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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/TS 12417:2011
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Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
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EN 12006-3:1998+A1:2009
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Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
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ISO 10555-3:2013
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Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters |
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CFR 21(PTS1-99) : 0
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FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
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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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ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice |
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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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ASTM D 638 : 2014 : REDLINE
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Standard Test Method for Tensile Properties of Plastics |
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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 |