| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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055
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Date of Entry 12/21/2020
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FR Recognition Number
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2-281
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| Standard | |
| ISO /TS 10993-19 Second edition 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials |
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Scope/AbstractThis document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. 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 document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, 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 is not applicable when the material or device is not in contact with the body directly or indirectly. |
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| Extent of Recognition
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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. |
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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| FDA recognition of ISO/TS 10993-19 First edition 2006-06-01 [Rec# 2-167] will be superseded by recognition of ISO/TS 10993-19 Second edition 2020-03 [Rec# 2-281].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. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
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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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
