NEMA XR 27
X-ray Equipment for Interventional Procedures User Quality Control Mode
|Publication Date:||1 January 2012|
This standard applies to x-ray equipment intended to perform interventional procedures and defines a set of minimum requirements designed to more easily facilitate quality control at the facility level. In particular, items pertinent to the following quality control elements are contained within:
• Physical testing of equipment;
• Electronic audit of system configuration; and,
• Electronic reporting of relevant data and information.
This first edition sets the requirements for fixed x-ray interventional equipment indicated for prolonged x-ray procedures (e.g., neuroradiological and cardiovascular procedures as indicated in the annex AA of IEC 60601-2-43:2010).
The x-ray equipment falling under this standard is hereafter referred to as equipment.
use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer (ISO 14971:2000).