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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 046 Date of Entry 12/23/2016 
FR Recognition Number 2-245
Standard(Included in ASCA)
ISO  10993-5 Third edition 2009-06-01
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Identical Adoption
ANSI AAMI ISO 10993-5:2009/(R)2014
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Scope/Abstract
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.

These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.

These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
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.
ASCA Notes
The following test method is included in the ASCA pilot program:
MEM Elution Cytotoxicity (Qualitative evaluation per Table 1 in subclause 8.5.1 of ISO 10993-5:2009).
Public Law, CFR Citation(s) and Procode(s)*
21 CFR Part 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 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
 Chandramallika (Molly) Ghosh
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6496
  molly.ghosh@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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