• 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 044 Date of Entry 07/26/2016 
FR Recognition Number 2-241
Standard
ISO /TR 37137 First edition 2014-05-15
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
U.S. Identical Adoption
ANSI AAMI ISO /TR 37137:2014
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
Scope/Abstract
The objective of this Technical Report is to provide interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO 10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 6.3a) 1) i) I)
Clause 6.4a) 1) i)
Clause 6.5a) 4) i) I)
Clause 6.6c) 2) i) I)
Clause 6.6e) 1) ii)
Clause 6.8a) 1) i)
Clause 6.10a) 1) i) I)
Clause 6.11 f) 2) and f) 3)
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 10993-3:2014, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.

ISO 10993-4:2002, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood.

ISO 10993-6:2007, Biological evaluation of medical devices - Part 6: Tests for local effects after implantation.

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,
FDA Technical Contact
 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.
-
-