SCOPE OF THE DOCUMENT

This document defines the minimum set of quality control (QC) tests to be applied to the [Manufacturer to enter commercial name of hardcopy device], a hardcopy output device that receives images from an FFDM system, and reproduces them on [Manufacturer to enter description of hardcopy medium] for final interpretation. It should be considered as one element of the mammography facility’s Quality Assurance Plan.

The tests in this manual generally focus on device constancy, that is, the ability of the hardcopy device to maintain its expected imaging performance over time. They do not address system quality control, for example, the ability of the various system components (image receptor, acquisition workstation, diagnostic workstations, hardcopy output device) to communicate properly with each other, and to use the communicated information correctly. Such system QC activities are assumed to have occurred during initial system installation, initial system acceptance, or as part of a Mammography Equipment Evaluation (see 4.11).

Customers who purchased NEMA XR 23
also purchased

• ABNT NBR ISO 14971 : Produtos de saúde – Aplicação de gerenciamento de risco a produtos para a saúde
• NEMA XR 22 : “QUALITY CONTROL MANUAL” TEMPLATE FOR MANUFACTURERS OF DISPLAYS AND WORKSTATIONS LABELED FOR FINAL INTERPRETATION IN FULL-FIELD DIGITAL MAMMOGRAPHY

See More Documents