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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 055 Date of Entry 12/21/2020 
FR Recognition Number 2-288
ISO  10993-15 Second edition 2019-11
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
This document specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use.
This document is applicable only to those degradation products generated by chemical alteration of the final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results approximate the in vivo behaviour of the implant or material. The described chemical methodologies are a means to generate degradation products for further assessments.
This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.
This document is not applicable to evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available.
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993.
Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (<10-6 w/w) contained in the specific metal or alloy is not addressed in this document, nor are specific requirements for acceptable levels of degradation products provided in this document.
This document excludes the biological activity of the degradation products. (See instead the applicable clauses of ISO 10993-1 and ISO 10993-17).
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 5.2 second paragraph.
Rationale for Recognition
This standard is recognized on a scientific basis: Biocompatibility.

This standard is recognized in part because:
Clause 5.2 second paragraph is in conflict with other recognized standards ASTM F2129, section 8.1.2, ASTM F3306 section 8.3 as well as FDA guidance (reference #3) section III C.1 and FDA guidance (reference #4) section IV C.2 listed below.
Relevant FDA Guidance and/or Supportive Publications*
1. ASTM F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices.

2. ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants.

3. Guidance for Industry and Food and Drug Administration Staff: Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued August 2015.

4. Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol, Issued October 2020.

5. 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
 David M. Saylor
 Scott McNamee
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.