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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 044 Date of Entry 07/26/2016 
FR Recognition Number 2-174
Standard(Included in ASCA)
ISO  10993-10 Third Edition 2010-08-01
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Identical Adoption
ANSI AAMI ISO 10993-10:2010/(R)2014
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

This part of ISO 10993 includes:

a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;

b) details of in vivo (irritation and sensitization) test procedures;

c) key factors for the interpretation of the results.

Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
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:
Dermal Irritation;
Intracutaneous Reactivity Irritation;
Guinea Pig Maximization Sensitization, in conjunction with ASTM F720-17 (recognition number: 2-256);
Closed Patch Sensitization.
Transition Period
FDA recognition of ISO 10993-10 Third Edition 2010-08-01 [Rec# 2-174] will be superseded by recognition of ISO 10993-10 Fourth edition 2021-11 [Rec# 2-296]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-174] until December 22, 2024. After this transition period, declarations of conformity to [Rec# 2-174] will not be accepted.
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.

For further information on use of the LLNA method see FDA January 13, 2011 letter to RADM Stokes, National Toxicology Program regarding FDA use of the ICCVAM methods for LLNA.

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 Contacts
 Chandramallika (Molly) Ghosh
 Shelby Skoog
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.