| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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2-307
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| Standard | |
ASTM F1877-24
Standard Practice for Characterization of Particles |
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Scope/Abstract1.1 This practice covers a series of recommendations, generally applicable to all medical devices, for characterization of the morphology, shape, size, and size distribution of particles. The methods utilized include sieves, optical, scanning electron
microscopy (SEM), transmission electron microscopy (TEM), and electrooptical.
1.2 While characterizing the quantity or number of particles shed from medical devices is important, this is not covered within the scope of the current document. AAMI TIR 42 and USP <788> provide guidelines for determination of particle quantities in various size ranges.
1.3 These methods are appropriate for particles produced by a number of different methods. These methods can include simulated use approaches such as in vitro wear test machines (Test Method F732), total joint simulation systems (Guides F1714 and F1715), abrasion testing, and vascular durability testing (Guide F2942). Other methods for producing particles such as shatter boxes or pulverizers, as well as commercially available particles, and particles harvested from tissues in animal or clinical studies can be used.
1.4 Except for chemical composition, this standard does not address sample preparation procedures and/or test systems that can be affected by chemical properties (for example, solubility, miscibility). While this standard does not provide detailed recommendations regarding assessment of chemical properties of particles, these should be considered.
1.5 The particles may be metallic, polymeric, or ceramic and are released from medical device materials either acutely or chronically (for example, due to wear).
1.6 The digestion procedures to be used and issues of sterilization of retrieved particles are not the subject of this practice.
1.7 A classification scheme for description of particle morphology is included in Appendix X3.
1.8 When nanoparticles (that is, having at least one dimension less than 100 nm) are known to be present or are expected, other characterization methods may be needed. For information regarding nanoparticle characterization, refer to standards that address nanoparticles (for example, ISO 21363, ISO/TR 10993-22, ISO/TR 16196).
1.9 This standard does not address ions released from medical devices.
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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 ASTM F1877-16 [Rec# 2-246] will be superseded by recognition of ASTM F1877-24 [Rec# 2-307]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-246] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 2-246] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
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. |
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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. |
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