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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 2-274
Standard
ASTM  F749-20
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
Scope/Abstract
1.1 This practice is an intracutaneous reactivity test used to assess the potential of the material under test to produce irritation following intradermal injections of extracts of the material.

1.2 The liquids injected into the rabbits are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.

1.3 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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR Part 58 Good Laboratory Practice for Nonclincal Laboratory Studies
Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

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.
FDA Technical Contact
 Simona Bancos
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6860
  simona.bancos@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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