{"id":2241,"date":"2026-09-09T07:56:21","date_gmt":"2026-09-09T07:56:21","guid":{"rendered":"https:\/\/hemodiyalizsuaritma.com\/?p=2241"},"modified":"2026-09-09T07:56:47","modified_gmt":"2026-09-09T07:56:47","slug":"haemodialysis-system-fat-sat","status":"publish","type":"post","link":"https:\/\/hemodiyalizsuaritma.com\/en\/haemodialysis-system-fat-sat\/","title":{"rendered":"FAT, SAT and Commissioning Acceptance Tests for Haemodialysis Water Treatment Systems"},"content":{"rendered":"\n

Purchasing and installing a haemodialysis water treatment system does not, by itself, prove that the system is ready for clinical use. A structured haemodialysis system FAT SAT<\/strong> programme verifies that the equipment was manufactured to the approved design, performs its safety functions, integrates correctly with the facility and produces water that meets defined quality requirements. The factory acceptance test, or FAT, is completed before shipment at the manufacturer\u2019s facility. The site acceptance test, or SAT, is performed after installation with the actual feed water, utilities and distribution loop.<\/p>\n\n\n\n

\"Haemodialysis<\/figure>\n\n\n\n

A credible acceptance process covers more than starting the unit and reading conductivity from the display. Mechanical integrity, electrical protection, automation sequences, capacity, pressure, flow, alarm and interlock scenarios, loop conditions, sampling, staff training and documentation must be evaluated as one system. Final release should be traceable to the approved specification, risk assessment, manufacturer\u2019s instructions, applicable standards and competent laboratory results. Acceptance criteria must be agreed before testing, not invented after a result is obtained.<\/p>\n\n\n\n

What Should Be Checked During the Factory Acceptance Test?<\/h2>\n\n\n\n

The purpose of FAT is to identify and resolve design, assembly and functional nonconformities before the equipment reaches site. The protocol should define scope, responsibilities, prerequisites, test methods, instruments, acceptance criteria and deviation handling before execution. ISO 23500-2:2024<\/a> addresses individual water treatment devices and complete systems, including piping, fittings and online water quality monitoring between the incoming water point and the point of use. This scope supports a system-level FAT rather than a test limited to the RO pump or membrane skid.<\/p>\n\n\n\n

The test team commonly includes the manufacturer or system integrator, the purchaser\u2019s technical representative, biomedical or clinical engineering personnel and, where required, an independent verification party. At the opening meeting, the approved process flow diagram, equipment list, electrical drawings, control philosophy, software version and technical specification should be checked for a consistent revision status. Each result is then recorded with the date, instrument identity, calibration status, test condition, expected outcome, actual outcome and witness approval.<\/p>\n\n\n\n

Each FAT step should state its prerequisites, including feed-water characteristics, temporary loop arrangement, tank level, valve positions and simulated demand. A failed item receives a deviation reference, corrective action and repeat-test record. Safety, water quality or essential performance failures remain shipment blockers until objective closure evidence is available.<\/p>\n\n\n\n

Stage<\/th>Main purpose<\/th>Primary evidence<\/th>Release decision<\/th><\/tr><\/thead>
Document review<\/td>Confirm the built system matches the approved design<\/td>Drawings, lists and certificates<\/td>Ready for testing<\/td><\/tr>
FAT<\/td>Verify function and performance before shipment<\/td>Signed test records<\/td>Approved for shipment<\/td><\/tr>
SAT<\/td>Verify integration under actual site conditions<\/td>Site readings and scenarios<\/td>Ready for commissioning<\/td><\/tr>
Final acceptance<\/td>Close water quality, training and documentation<\/td>Analysis reports and handover file<\/td>Clinical release review<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Mechanical, electrical and automation function tests<\/h3>\n\n\n\n

The short answer for mechanical inspection is that the equipment, piping and connections must match the approved design without leaks, unsuitable materials, reversed flow paths or inaccessible service points. The frame, panels, pumps, membrane housings, filters, valves, sample ports, drain connections and hygienic contact surfaces should be examined visually and functionally. Pipe labels and flow arrows need to remain readable after final assembly because clear identification reduces the chance of incorrect intervention during operation and maintenance.<\/p>\n\n\n\n

\"Haemodialysis<\/figure>\n\n\n\n

Leak testing should follow the protocol\u2019s pressure and duration, with attention to pump seals, sensor ports, membrane housings and concealed joints. Thermal or chemical disinfection requires confirmation of material compatibility. The distribution side also needs review; PEX-A loop piping and hygienic connections<\/a> must be assessed against the actual route and intended disinfection method.<\/p>\n\n\n\n

Electrical checks compare the panel with the drawings and verify wire numbering, terminals, protective earthing, circuit and motor protection, phase sequence and emergency-stop circuits. Voltage and frequency must suit the destination. Motor rotation, dry-run protection and safe response to power loss are demonstrated. Measuring-instrument calibration records belong in the acceptance file.<\/p>\n\n\n\n

Automation testing follows the normal operating sequence step by step. Level, pressure, flow, conductivity and temperature sensors must map to the correct inputs, and displayed readings should agree with a suitable reference. Manual and automatic modes, access levels, event logs, timers and remote monitoring are tested. Software is recorded and backed up; post-FAT changes require controlled revision and targeted retesting.<\/p>\n\n\n\n