Standards

ASTM WK35656

(What is a Work Item? / How to Input to a Work Item)

Work Item: ASTM WK35656 - Revision of F561 - 05a(2010) Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids


Active Standard: F561 - 05a(2010)

Developed by Subcommittee: F04.15 | Committee F04 Home | Contact Staff Manager



1. Rationale

The main purpose of this revision is to incorporate an additional protocol for the digestion and recovery of wear particles from joint fluids, tissues and wear simulator lubricants. The new protocol is applicable to debris from polyethylene, metal and ceramic implants, and provides a high percentage of particle recovery, low contaminants and excellent dispersion (lack of clumping), which greatly facilitates morphological characterization using automated digital image analysis.


Keywords

ceramics; chemical analysis; composites; histology; implant retrieval; metals; particles; polymers; Associated tissues (surgical implants); Biocompatibility; Ceramic surgical materials/applications; Composites--surgical implants; Implantable surgical materials/applications; Metallic surgical implant materials; Nondestructive evaluation (NDE)--surgical implants; Polymers (surgical applications); Revision implant surgery; Testing methods--surgical implants; Tissue reactions ;

Citing ASTM Standards

[Back to Top]




Work Item Status:
Date Initiated:12-14-2011
Technical Contact: Harry McKellop

Item: 001
Ballot: F04 (13-04)
Status: Ballot Item Approved

Item: 002
Ballot: F04 (13-04)
Status: Ballot Item Approved

Item: 003
Ballot: F04 (13-04)
Status: Ballot Item Approved

Item: 014
Ballot: F04 (12-06)
Status: Negative Votes Need Resolution

Standards Tracker

Standards Subscriptions