BS EN ISO 10993-11:2009
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Biological evaluation of medical devices Tests for systemic toxicity |
AAMI ISO 10993-11 : 2006 : R2014
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
ASTM E 2097 : 2000 : R2006
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Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products |
ASTM F 2042 : 2000 : R2005
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Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
ASTM F 719 : 1981 : R1996 : EDT 1
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Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation |
ASTM F 813 : 2007
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Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
I.S. EN ISO 10993-11:2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY (ISO 10993-11:2006) |
ASTM F 602 : 2009
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Standard Criteria for Implantable Thermoset Epoxy Plastics |
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 2147 : 2001 : R2016
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Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
ASTM E 2097 : 2000 : R2014
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Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products (Withdrawn 2022) |
ASTM F 1904 : 2014 : REDLINE
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Standard Practice for Testing the Biological Responses to Particles in vivo |
ASTM F 3089 : 2014
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Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
ASTM F 719 : 1981 : R2007
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Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation |
DIN EN ISO 10993-11 E : 2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
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 |
ASTM F 3127 : 2016
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Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
ASTM F 719 : 1981 : R2012
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Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation |
BS ISO 12891-2:2014
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Retrieval and analysis of surgical implants Analysis of retrieved surgical implants |
ASTM E 2097 : 2000
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Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products |
ASTM F 2042 : 2000 : EDT 1
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Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
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 |
ASTM F 2027 : 2016 : REDLINE
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Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
ASTM F 813 : 2007 : R2012
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Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
ASTM F 750 : 1987 : R1996
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Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
ASTM F 982 : 1986 : R2002
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Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion |
ASTM F 2565 : 2013 : REDLINE
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Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
ASTM F 2759 : 2011 : REDLINE
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Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices |
ASTM F 719 : 1981 : R2002 : EDT 1
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Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation |
ASTM F 561 : 2013
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Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
UNI EN ISO 10993-11 : 2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
ASTM F 1906 : 1998 : R2003
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Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011) |
EN ISO 10993-11:2009
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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
ASTM F 602 : 2009 : R2014
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Standard Criteria for Implantable Thermoset Epoxy Plastics |
ASTM F 1903 : 2010-07
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PRACTICE FOR TESTING FOR BIOLOGICAL RESPONSES TO PARTICLES IN VITRO |
ASTM F 750 : 1987 : R2002 : EDT 1
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Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
ASTM F 1905 : 1998
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Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity |
ASTM F 451 : 2016
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Standard Specification for Acrylic Bone Cement |
ASTM F 2147 : 2001
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Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
ASTM F 2042 : 2000 : R2011
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Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication |
CSA ISO 10993-11 : 0
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TEST FOR SYSTEMIC TOXICITY |
ASTM F 750 : 1987 : R2007 : EDT 1
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Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
ASTM F 2042 : 2000
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
ASTM F 602 : 2009 : R2015
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Standard Criteria for Implantable Thermoset Epoxy Plastics |
13/30242622 DC : 0
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BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS |
ASTM F 982 : 1986 : R1998
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Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion |
ASTM F 1906 : 1998
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Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration |
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 648 : 2014 : REDLINE
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Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
ASTM F 2151 : 2001
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Standard Practice for Assessment of White Blood Cell Morphology After Contact with Materials (Withdrawn 2007) |
ASTM F 2147 : 2001 : R2010
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Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
ASTM F 2695 : 2012 : REDLINE
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Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
ASTM F 2147 : 2001 : R2006
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Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
ASTM F 749 : 2013 : REDLINE
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Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
ASTM F 750 : 1987 : R2012
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Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
ISO 12891-2:2014
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Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants |
ASTM F 750 : 1987 : R2007
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Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
ASTM F 756 : 2017 : REDLINE
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Standard Practice for Assessment of Hemolytic Properties of Materials |
ISO 10993-11:2017
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Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
ASTM F 604 : 1994
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Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001) |
ASTM F 1905 : 1998 : R2003
|
Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011) |
ASTM F 750 : 1987 : R2002
|
Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
DIN EN ISO 10993-11:2015-12 (Draft)
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
ASTM F 748 : 2016 : REDLINE
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Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
ASTM F 982 : 1986 : R2008
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Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017) |
ASTM F 719 : 1981 : R2007 : EDT 1
|
Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation |
ASTM F 720 : 2017 : REDLINE
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Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
DIN EN ISO 10993-11:2009-08
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |