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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 056 Date of Entry 06/07/2021 
FR Recognition Number 2-291
Standard(Included in ASCA)
ISO  10993-23 First edition 2021-01
Biological evaluation of medical devices - Part 23: Tests for irritation
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-2.
This document includes:
- pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
- details of in vitro and in vivo irritation test procedures;
- key factors for the interpretation of the results.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 4 General principles - Step-wise approach
Clause 6 In vitro irritation tests
Annex B
Annex C
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.

This standard is recognized in part because:

Clause 4, Clause 6, Annex B, Annex C are in conflict with an existing FDA published guidance. See Section B (page 20) of the guidance listed below, which states "With the advancement of scientific knowledge regarding the basic mechanisms of tissue responses, FDA agrees with the ISO 10993-1:2009 revision focus on minimizing the "number and exposure of test animals by giving preference to chemical constituent testing and in vitro models, in situations where these methods yield equally relevant information to that obtained from in vivo models."
ASCA Notes
The following test methods are included in the ASCA pilot program:
In Vivo Dermal Irritation;
Intracutaneous Reactivity Irritation.
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*
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 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.