BRH Routine Compliance Testing for Diagnostic X-Ray Systems of Components of Diagnostic X-Ray Systems to Wich 21CFR Subchapter J is Applicable.

摘要

The manual was developed by the Bureau of Radiological Health to establish procedures for the routine testing of Diagnostic X-Ray Systems for compliance with the Federal Performance Standard 21CFR 1020.30. The manual has two major subject areas: (1) testing procedures and (2) test equipment. The consolidated procedures and routine test equipment will be used for screening diagnostic x-ray systems for evidence of noncompliance with the Performance Standard. More rigorous followup testing will be performed as required.