Work Item
ASTM WK82773

Revision of F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

Rationale

The title and scope have been revised to clarify that this standard is for raw materials, not for finished implants. Section 3.3 has been revised to clarify that the elemental impurities requirements for conformance with this standard are limited to analysis and reporting, and that any specific limits are to be agreed upon between the supplier and the purchaser. In addition, guidance on quality management in section 4 has been updated, and a section 5 on certification has been added.

Details

Developed by Subcommittee: F04.13

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 07-15-2022

Technical Contact: Jon Moseley

Item: 001

Ballot: F04.13 (22-01)

Status: Negative Votes Need Resolution