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.
Date Initiated: 07-15-2022
Technical Contact: Jon Moseley
Item: 001
Ballot: F04.13 (22-01)
Status: Negative Votes Need Resolution