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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 047 Date of Entry 08/21/2017 
FR Recognition Number 2-246
Standard
ASTM  F1877-16
Standard Practice for Characterization of Particles
Scope/Abstract
1.1 This practice covers a series of procedures for characterization of the morphology, number, , and distribution of particles. The methods utilized include sieves, optical, scanning electron microscopy (SEM), transmission electron microscopy (TEM), and electrooptical.

1.2 These methods are appropriate for particles produced by a number of different methods. These include wear test machines (Test Method F732), total joint simulation systems (Guides F1714 and F1715), abrasion testing, methods for producing particulates, such as shatter boxes or pulverizers, commercially available particles, and particles harvested from tissues in animal or clinical studies.

1.3 The debris may include metallic, polymeric, ceramic, or any combination of these.

1.4 The digestion procedures to be used and issues of sterilization of retrieved particles are not the subject of this practice.

1.5 A classification scheme for description of particle morphology is included in Appendix X3.

1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7 As a precautionary measure, removed debris from implant tissues should be sterilized or minimally disinfected by an appropriate means that does not adversely affect the particulate material.
Extent of Recognition
Complete standard
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.
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.
FDA Technical Contact
 Shin Hainsworth
  FDA/CDRH/OSE/DBCMS/
  301-348-3986
  hainsworth.shin@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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