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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 2-255
Standard(Included in ASCA pilot)
ISO 10993-11 Third edition 2017-09
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
U.S. Identical Adoption
ANSI AAMI ISO 10993-11: 2017
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Scope/Abstract
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
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 methods are included in the ASCA pilot program:
Acute Systemic Toxicity;
Material-Mediated Pyrogenicity, in conjunction with USP <151> (recognition number: 2-272).
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.

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 June 2016. Updated September 2020.
FDA Technical Contacts
 Rakhi Dalal
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6418
  rakhi.dalal@fda.hhs.gov
 Annabelle Crusan
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  301-796-4926
  Annabelle.Crusan@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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