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ASTM F 756 : 2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Practice for Assessment of Hemolytic Properties of Materials

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

31-12-2010

1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood.

1.2 This practice is intended to evaluate the acute in vitro hemolytic properties of materials intended for use in contact with blood.

1.3 This practice consists of a protocol for a hemolysis test under static conditions with either an extract of the material or direct contact of the material with blood. It is recommended that both tests (extract and direct contact) be performed unless the material application or contact time justifies the exclusion of one of the tests.

1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 This 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.

Committee
F 04
DocumentType
Standard Practice
Pages
5
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 3089 : 2023 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
ASTM F 2565 : 2021 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
ASTM E 2524 : 2022 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
ASTM F 2848 : 2021 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
ASTM F 2212 : 2020 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
ASTM F 2347 : 2015 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F 2695 : 2012 : R2020 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
ASTM F 2103 : 2018 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F 2901 : 2019 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
ASTM F 2064 : 2017 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F 451 : 2021 Standard Specification for Acrylic Bone Cement
ASTM F 748 : 2016 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 2759 : 2019 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
ASTM F 2224 : 2009 : R2020 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
ASTM F 648 : 2021 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

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$122.77
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