| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
061
|
Date of Entry 12/18/2023
|
|
FR Recognition Number
|
18-24
|
| Standard | |
ASTM E2524-22
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles |
|
Scope/Abstract1.1 This test method covers assessing the effect of nanoparticulate materials on the integrity of red blood cells.
1.2 This test method uses diluted whole blood incubated with nanoparticulate material and the hemoglobin released from damaged red blood cells is determined.
1.3 This test method is similar to Practice F756 with the volumes reduced to accommodate nanoparticulate material.
1.4 This test method is part of the in-vitro preclinical characterization and is important for nanoparticulate material that will contact the blood in medical applications.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
|
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
- Section 8.6 Preparation of Nanoparticulate Test Samples
- Section 13.2 Interferences
|
|
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:
- Section 8.6 is in conflict with an existing FDA published guidance, see paragraph 2, bullet #3 on Page 27 of Section V. D. Submicron or Nanotechnology Components of the guidance #1 listed below.
- Section 13.2 is in conflict with an existing FDA published guidance, see paragraph 3 bullet #2 on Page 28 of Section V. D. Submicron or Nanotechnology Components of the guidance #1 listed below. |
|
Relevant FDA Guidance and/or Supportive Publications*
1. 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 2020.
2. (Recognition Number 2-258) ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
