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ASTM F 619 : 2014 : REDLINE
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Practice for Extraction of Medical Plastics
26-09-2020
English
01-03-2014
CONTAINED IN VOL. 13.01, 2015 Defines methods of extraction of medical plastics and may be applicable to other materials.
Committee |
F 04
|
DocumentType |
Redline
|
Pages |
5
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy |
1.1This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.
1.2This practice may be used for, but is not limited to the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a referee method for the measurement of extractables in plastics used in medical devices.
1.31.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.
1.4The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
1.5This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
BS EN ISO 10993-11:2009 | Biological evaluation of medical devices Tests for systemic toxicity |
AAMI ISO 10993-11 : 2006 : R2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
ASTM E 2097 : 2000 : R2006 | Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products |
ASTM F 2042 : 2000 : R2005 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
ASTM F 719 : 1981 : R1996 : EDT 1 | Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation |
ASTM F 813 : 2007 | Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
I.S. EN ISO 10993-11:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY (ISO 10993-11:2006) |
ASTM F 602 : 2009 | Standard Criteria for Implantable Thermoset Epoxy Plastics |
ASTM F 2212 : 2011 : REDLINE | 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 | Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
ASTM E 2097 : 2000 : R2014 | 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 | Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph> |
ASTM F 3089 : 2014 | Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
ASTM F 719 : 1981 : R2007 | Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation |
DIN EN ISO 10993-11 E : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
ASTM F 2347 : 2015 : REDLINE | 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 | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
ASTM F 719 : 1981 : R2012 | Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation |
BS ISO 12891-2:2014 | Retrieval and analysis of surgical implants Analysis of retrieved surgical implants |
ASTM E 2097 : 2000 | Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products |
ASTM F 2042 : 2000 : EDT 1 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
ASTM F 2064 : 2017 : REDLINE | 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 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
ASTM F 813 : 2007 : R2012 | Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
ASTM F 750 : 1987 : R1996 | Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
ASTM F 982 : 1986 : R2002 | Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion |
ASTM F 2565 : 2013 : REDLINE | Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
ASTM F 2759 : 2011 : REDLINE | 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 | Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation |
ASTM F 561 : 2013 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
UNI EN ISO 10993-11 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
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) |
EN ISO 10993-11:2009 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
ASTM F 602 : 2009 : R2014 | Standard Criteria for Implantable Thermoset Epoxy Plastics |
ASTM F 1903 : 2010-07 | PRACTICE FOR TESTING FOR BIOLOGICAL RESPONSES TO PARTICLES IN VITRO |
ASTM F 750 : 1987 : R2002 : EDT 1 | Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
ASTM F 1905 : 1998 | Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity |
ASTM F 451 : 2016 | Standard Specification for Acrylic Bone Cement |
ASTM F 2147 : 2001 | Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
ASTM F 2042 : 2000 : R2011 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication |
CSA ISO 10993-11 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TEST FOR SYSTEMIC TOXICITY |
ASTM F 750 : 1987 : R2007 : EDT 1 | 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 | Standard Criteria for Implantable Thermoset Epoxy Plastics (Withdrawn 2024) |
13/30242622 DC : 0 | BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS |
ASTM F 982 : 1986 : R1998 | Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion |
ASTM F 1906 : 1998 | Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration |
ASTM F 2103 : 2011-03 | 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 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
ASTM F 2151 : 2001 | Standard Practice for Assessment of White Blood Cell Morphology After Contact with Materials (Withdrawn 2007) |
ASTM F 2147 : 2001 : R2010 | Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
ASTM F 2695 : 2012 : REDLINE | 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 | Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
ASTM F 749 : 2013 : REDLINE | Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
ASTM F 750 : 1987 : R2012 | Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
ISO 12891-2:2014 | Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants |
ASTM F 750 : 1987 : R2007 | Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse |
ASTM F 756 : 2017 : REDLINE | Standard Practice for Assessment of Hemolytic Properties of Materials |
ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
ASTM F 604 : 1994 | 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) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
ASTM F 982 : 1986 : R2008 | 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 | Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
DIN EN ISO 10993-11:2009-08 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
ASTM D 543 : 2014 : REDLINE | Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents |
ASTM D 1239 : 2014 : REDLINE | Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals |
ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
ASTM D 570 : 1998 : R2018 | Standard Test Method for Water Absorption of Plastics |
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