ASTM F 1877 : 2016 : REDLINE
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Standard Practice for Characterization of Particles |
ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories |
ASTM F 2150 : 2013 : REDLINE
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Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
ASTM F 139 : 2012
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Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) |
ISO 10993-13:2010
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Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
ASTM F 2212 : 2011 : REDLINE
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Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
ASTM F 1472 : 2014 : REDLINE
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Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
ASTM F 90 : 2014 : REDLINE
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Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
BS EN 12442-3:2000
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Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents |
BS EN 12442-2:2000
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Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling |
ASTM F 1377 : 2013 : REDLINE
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Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
ASTM F 136 : 2013 : REDLINE
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Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
CFR 21(PTS800-1299) : 0
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FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
ASTM F 451 : 2016
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Standard Specification for Acrylic Bone Cement |
ASTM F 1635 : 2016 : REDLINE
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Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
ISO 10993-14:2001
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Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
ASTM F 2103 : 2011-03
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GUIDE FOR CHARACTERIZATION AND TESTING OF CHITOSAN SALTS AS STARTING MATERIALS INTENDED FOR USE IN BIOMEDICAL AND TISSUE-ENGINEERED MEDICAL PRODUCT APPLICATIONS |
ASTM F 2064 : 2017 : REDLINE
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Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
ISO 10993-18:2005
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Biological evaluation of medical devices Part 18: Chemical characterization of materials |
ASTM F 3160 : 2016
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Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
ASTM F 560 : 2017 : REDLINE
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Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
ASTM F 1538 : 2003 : EDT 1
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Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
ISO 10993-12:2012
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Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
ASTM F 619 : 2014 : REDLINE
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Standard Practice for Extraction of Medical Plastics |
ASTM F 1873 : 1998
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Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007) |
ISO 10993-17:2002
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
ASTM F 2347 : 2015 : REDLINE
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Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 6474:1994
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Implants for surgery Ceramic materials based on high purity alumina |
CFR 21(PTS600-799) : 0
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FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 600-799 |
ASTM F 1537 : 2011 : REDLINE
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Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
ISO 10993-9:2009
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Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
BS EN 12442-1:2000
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Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
ASTM F 562 : 2013 : REDLINE
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Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
ASTM F 2848 : 2017 : REDLINE
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Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
ASTM F 648 : 2014 : REDLINE
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Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |