| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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049
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Date of Entry 06/07/2018
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FR Recognition Number
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2-250
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| Standard | (Included in ASCA) |
ASTM F756-17
Standard Practice for Assessment of Hemolytic Properties of Materials |
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Scope/Abstract1.1 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 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. |
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| Extent of Recognition
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Rationale for Recognition
| Standard is recognized on a scientific basis: Biocompatibility |
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ASCA Notes
| Used in conjunction with ISO 10993-4: 2017 (recognition number 2-248). |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
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Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ASTM F619-14 Standard Practice for Extraction of Medical Plastics
Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued September 2023.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
