• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 2-268
Standard
ISO /TS 21726 First edition 2019-02
Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Scope/Abstract
This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a medical device. The TTC values in this document can be used for:

- comparing to a maximum concentration of an identified or unidentified constituent in an extract (see ISO 10993-18);

- supporting toxicological equivalence;

- comparing to a maximum exposure dose estimate of an identified constituent (see ISO 10993-17).

NOTE Constituent is defined in 3.1.

ISO 10993-18 specifies how to convert TTC (µg/d) into a concentration (µg/ml).

TTC is not applicable to constituents with adequate toxicity data for deriving a tolerable intake (TI) value (see ISO 10993-17).

The TTC values established in this document are protective for carcinogens, systemic toxicants, and reproductive toxicants (see Clause 5). This document does not include TTC values for other biological endpoints assessed as part of the biological evaluation of a medical device, per ISO 10993-1, for example:

- cytotoxicity;

- irritation;

- sensitization;

- hemocompatibility;

- material mediated pyrogenicity;

- local effects that occur in tissues at the site of contact between a medical device and the body (e.g. the observations from implantation studies).

The TTC values in this document do not apply to potential exposure via gas pathways of medical devices. For application of TTC for constituents present/released from these devices, see the ISO 18562 series.

The TTC values presented in this document are not applicable for the safety assessment of cohort of concern (see 5.3).
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.
Relevant FDA Guidance and/or Supportive Publications*
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.
FDA Technical Contacts
 Alan Hood
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-0313
  Alan.Hood@fda.hhs.gov
 Jennifer Goode
  FDA/OC/CDRH/OPEQ/CSPS/
  301-796-6374
  jennifer.goode@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.
-
-