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ASTM F 2743 : 2011
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Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems |
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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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ISO 25539-2:2012
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Cardiovascular implants Endovascular devices Part 2: Vascular stents |
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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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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 |
|
ISO 14937:2009
|
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 1635 : 2016 : REDLINE
|
Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
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ISO/IEC Guide 63:2012
|
Guide to the development and inclusion of safety aspects in International Standards for medical devices |
|
IEC 62366:2007+AMD1:2014 CSV
|
Medical devices - Application of usability engineering to medical devices |
|
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
|
ISO 14630:2012
|
Non-active surgical implants General requirements |
|
ISO/TR 14283:2004
|
Implants for surgery Fundamental principles |
|
ISO/IEC Guide 51:2014
|
Safety aspects Guidelines for their inclusion in standards |
|
ASTM F 2052 : 2015 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
|
AAMI TIR17 : 2008
|
COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
|
ISO 13781:2017
|
Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
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ASTM F 2213 : 2017 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
|
ISO/TS 12417:2011
|
Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
|
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
|
CFR 21(PTS1-99) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
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ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice |
|
ASTM F 2914 : 2012
|
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices |
|
ASTM F 1980 : 2016 : REDLINE
|
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
|
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
|
ISO 15223-1:2016
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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AAMI TIR42 : 2010
|
EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES |
|
ISO/TR 15499:2016
|
Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process |
|
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 |