Medical electrical equipment. Angiography X-ray equipment. Technical requirements for governmental purchases

2Scope / Description

This standard specifies the general requirements for the preparation and format of Technical Specifications (TS) when procuring medical equipment (MO) – angiography machines. This standard is a dedicated standard relative to GOST R 55719-2013, "Medical Electrical Equipment. Requirements for the Content and Format of Technical Specifications for High-Tech Medical Equipment Procurement Competition Documents." This standard applies to national and municipal procurement tenders for medical equipment. This standard does not apply to non-national procurement of medical equipment. This standard applies to X-ray diagnostic equipment for cardiovascular special diagnoses, which includes positioning stents for fluoroscopy and imaging of patients, the ability to inject contrast agents into the cardiovascular system, and one or more automated workstations. This standard does not apply to X-ray diagnostic equipment for fluoroscopy and imaging, C-arm film equipment, digital urology equipment, and pediatric equipment.