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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 2-279
Standard
ASTM F750-20
Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
Scope/Abstract
1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices.


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


1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection.


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.
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.
Transition Period
FDA recognition of ASTM F750-87 (Reapproved 2012) [Rec# 2-124] will be superseded by recognition of ASTM F750-20 [Rec# 2-279]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-124] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 2-124] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 58 Good Laboratory Practice for Nonclinical 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.

Use of International Standard ISO 10993-1, Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process. Guidance for Industry and Food and Drug Administration Staff. Issued June 2016. Updated September 2020.
FDA Technical Contacts
 Simona Bancos
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6860
  simona.bancos@fda.hhs.gov
 Dhanya Williams
  CDRH/OPEQ/OHTV/DHTVA
  301-796-6498
  Dhanya.Kumar@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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