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ASTM F 756 : 2017

Current
Current

The latest, up-to-date edition.

Standard Practice for Assessment of Hemolytic Properties of Materials
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-03-2017

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

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

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

1.3This 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.

1.4This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. Test Method E2524 provides a protocol using reduced test volumes to assess the hemolytic properties of blood-contacting nanoparticulate materials; this may include nanoparticles that become unbound from material surfaces.

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

1.6This 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.

1.7This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Committee
F 04
DocumentType
Standard Practice
Pages
6
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM E 2524 : 2008 : R2013 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles (Withdrawn 2022)
ASTM E 691 : 2020 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2019 : EDT 1 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2023 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 2524 : 2008 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
ASTM E 691 : 2022 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2009 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2021 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 2524 : 2022 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

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