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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 044 Date of Entry 07/26/2016 
FR Recognition Number 2-167
ISO /TS 10993-19 First edition 2006-06-01
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological, and topographical characterization of materials
U.S. Identical Adoption
ANSI AAMI ISO TIR 10993-19:2006
Biological evaluation of medical devices - Part 19: Physicochemical, morphological, and topographical characterization of materials
This Technical Specification provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.

This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. Chemical characterization of materials is covered by ISO 10993-18.

The ISO 10993 series of International Standards is not applicable when the material or device does not contact the body directly or indirectly (see ISO 10993-1:2003, 4.2).
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Annex A
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:
Annex A is in conflict with an existing published final guidance, see section III. B and section III. C of the guidance listed below.
Transition Period
FDA recognition of ISO/TS 10993-19 First edition 2006-06-01 [Rec# 2-167] will be superseded by recognition of ISO/TS 10993-19 Second edition 2020-03 [Rec# 2-281]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-167] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 2-167] will not be accepted.
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.

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
 Irada Isayeva
 Jiwen Zheng
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.