ASTM F 1251 : 1989 : R1995
|
Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices |
ASTM F 1904 : 1998 : R2003
|
Standard Practice for Testing the Biological Responses to Particles In Vivo |
ASTM F 1983 : 1999 : R2008
|
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
AAMI TIR19 : 1998
|
GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
ISO 10993-3:2014
|
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
ASTM F 1439 : 2003
|
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM F 1983 : 1999 : R2003
|
Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications |
ASTM F 756 : 2017 : REDLINE
|
Standard Practice for Assessment of Hemolytic Properties of Materials |
ASTM F 1906 : 1998
|
Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration |
CFR 21(PTS200-299) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299 |
ASTM F 1983 : 2014 : REDLINE
|
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
ASTM F 1904 : 1998 : EDT 1
|
Standard Practice for Testing the Biological Responses to Particles In Vivo |
ASTM F 763 : 2022
|
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
ASTM F 2148 : 2006 : REV A
|
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) |
ASTM F 1903 : 2010
|
Standard Practice for Testing For Biological Responses to Particles In Vitro |
ASTM F 763 : 2004 : R2016
|
Standard Practice for Short-Term Screening of Implant Materials |
ASTM F 2148 : 2013
|
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) |
ASTM F 1439 : 2003 : R2008
|
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM F 1904 : 2014
|
Standard Practice for Testing the Biological Responses to Particles in vivo |
ASTM F 1905 : 1998
|
Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity |
ASTM F 2148 : 2007
|
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) |
CFR 21(PTS800-1299) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
ASTM F 749 : 2013 : REDLINE
|
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
ASTM F 2148 : 2018
|
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) |
ASTM F 1903 : 2010-07
|
PRACTICE FOR TESTING FOR BIOLOGICAL RESPONSES TO PARTICLES IN VITRO |
ISO 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
ASTM F 2148 : 2007 : R2012
|
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) |
ASTM F 2148 : 2007 : EDT 1
|
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) |
ASTM F 1439 : 2003 : R2018
|
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM E 1298 : 1989 : R2000
|
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products |
ASTM E 1298 : 1989 : R1994
|
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products |
ISO 10993-10:2010
|
Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
ISO 13408-1:2008
|
Aseptic processing of health care products — Part 1: General requirements |
ASTM F 1904 : 1998 : R2008
|
Standard Practice for Testing the Biological Responses to Particles in vivo |
ASTM F 2148 : 2001
|
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) |
ASTM E 1298 : 2006
|
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014) |
ASTM F 1903 : 1998
|
Standard Practice for Testing for Biological Responses to Particles In Vitro |
ASTM F 619 : 2014 : REDLINE
|
Standard Practice for Extraction of Medical Plastics |
CFR 21(PTS300-499) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 300-499 |
ISO 10993-17:2002
|
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
ASTM F 763 : 1999
|
Standard Practice for Short-Term Screening of Implant Materials |
ASTM F 748 : 2016 : REDLINE
|
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
ASTM F 1905 : 1998 : R2003
|
Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011) |
ASTM F 1439 : 2002
|
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM F 720 : 2017 : REDLINE
|
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ASTM F 1903 : 2018
|
Standard Practice for Testing for Cellular Responses to Particles in vitro |
ISO 22442-2:2015
|
Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
ASTM F 1904 : 2014 : REDLINE
|
Standard Practice for Testing the Biological Responses to Particles in vivo |
ISO 10993-9:2009
|
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
ASTM F 1983 : 2014
|
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
ISO 22442-3:2007
|
Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
ASTM F 1906 : 1998 : R2003
|
Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011) |
ASTM F 1439 : 1992 : R1996
|
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM F 1251 : 1989 : R2003
|
Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012) |
ASTM F 1439 : 2003 : R2013
|
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
ASTM F 1983 : 1999
|
Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications |