Specification builder · Tier C
Fixed digital radiography (DR) X-ray room: floor-mounted or ceiling-suspended tube support, high-frequency generator, flat-panel detectors, table, wall stand, AEC, dose reporting and DICOM connectivity
A fixed digital X-ray room that takes chest, bone, abdomen and trauma images directly onto flat-panel detectors and sends them to PACS within seconds. Public hospitals at THQ, DHQ and tertiary level and private diagnostic centres buy it to replace film or CR rooms. The main tender decisions are generator power, tube heat capacity, number and quality of detectors, the level of motorisation, dose reporting, and making sure the room gets its PNRA licence.
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Standards this specification draws on
- IEC 60601-1 General basic safety and essential performance of medical electrical equipment, including the generator, table and tube support.
- IEC 60601-1-2 Electromagnetic compatibility, so the system neither disturbs nor is disturbed by other hospital equipment.
- IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment: leakage radiation, beam quality, filtration and dose indication.
- IEC 60601-2-54 Particular safety and essential performance requirements for X-ray equipment for radiography and radioscopy (the device-defining standard).
- IEC 62220-1-1 Method for measuring detective quantum efficiency (DQE) of digital X-ray detectors, so detector claims can be compared fairly.
- IEC 62494-1 Exposure index of digital X-ray imaging systems, so radiographers can see over- and under-exposure on every image.
- DICOM (NEMA PS3) Standard for image transfer, worklist, print and dose structured reports between the room, PACS and RIS.
- IEC 62304 Software life-cycle for the console, image processing and generator control software.
- ISO 14971 Risk management of the medical device by the manufacturer.
- ISO 13485 Quality management system of the manufacturer.
- DRAP Medical Devices Rules 2017 Registration/enlistment required to import and sell medical devices in Pakistan.
- PNRA Regulations PAK/904 and PAK/908 Pakistan radiation protection regulations and licensing of radiation facilities: import NOC for the generator, facility licence, shielding and dose limits.
Common mistakes in tenders for this equipment
- Copying one brand's brochure: exact detector pixel size (for example a single micron value), DQE figure, number of motorised axes or table weight that only one model has. Use 'not less than / not more than' values and accept any detector that meets DQE measured to IEC 62220-1-1.
- Comparing only generator kW: ask for the mA available at 100 kV and the shortest exposure time, and check that the hospital has a 3-phase supply and cable of the right size; many sites discover after delivery that the mains cannot feed the generator.
- Buying the machine before the room is ready: no layout drawing, shielding design or PNRA licence application, ceiling too weak for rails, or room too small. The system then sits in boxes for months and the warranty runs out unused.
- Accepting a warranty that excludes the X-ray tube or pro-rates it, or excludes dropped or liquid-damaged wireless detectors. Tube and detectors are together often a third or more of the system price.
- Paid software options after purchase: stitching, Modality Worklist, MPPS, RDSR, exposure index or reject analysis sold as extra licences. Require every listed function to be fully licensed in the bid price.
- Not testing PACS/RIS integration at acceptance: worklist not configured, images sent without patient ID, or DICOM services missing from the conformance statement.
- Accepting DRAP registration of the detector or the brand only, not the complete offered system, or offering refurbished or end-of-production models; also forgetting that the bidder, not the hospital, must get the PNRA import NOC.
- Ordering lead aprons, screen and personal dosimetry separately later; the room then fails its PNRA inspection and staff work unprotected.