Is a manufacturer's own test report enough for UNDP?

For the performance reports in section 5.2.3, UNDP asks for reports from a laboratory accredited by an ILAC member authority and certified to ISO 17025, or from an EU notified body.

How long should the plant run before commissioning?

WHO (2024) asks for at least 72 hours of continuous operation to test the entire system before commissioning; UNDP (2025) asks for performance tests of at least three days of continuous operation.

What third-party test reports prove an oxygen plant's performance?

Q: What third-party laboratory test reports do UN agencies ask for as proof that an oxygen plant meets its performance standards?

In UNDP procurement, REQ-OXY-001 (2025) asks for purity, flow and pressure test reports from a laboratory accredited by an ILAC member and certified to ISO 17025, or from an EU notified body; WHO's 2024 specifications ask for safety and performance tests from an accredited laboratory or third party, where applicable.

What third-party laboratory test reports do UN agencies ask for as proof that an oxygen plant meets its performance standards?

UNDP requirements (2025)

UNDP's REQ-OXY-001 (effective 1 January 2025), section 5.2.3, asks for official performance test reports for the key parameters of oxygen generators, including purity, flow and pressure, with all pages in English. The reports must come either from test laboratories accredited by an authority that is a member of the International Laboratory Accreditation Cooperation (ILAC), or from an EU notified body.

The accredited laboratory must be certified to ISO 17025, and the report should show its name, address and accreditation.
The test standards must be within the scope of the laboratory's accreditation.
The bidder should provide instructions for authenticating the test reports and certificates.

Its document checklist (Annex I) also lists a certificate of conformity or test report of compliance with harmonised standards issued by a laboratory accredited to ISO 17025, and a certificate of analysis of oxygen purity against the International, US and European pharmacopoeias.

WHO technical specifications (2024)

The WHO Technical specifications for health facility based medical oxygen systems (31 December 2024), whose oxygen generator plant specification supersedes the 2020 interim PSA specification, ask for compliance with the latest version of listed international standards, or regional or national equivalents, including technical tests for safety and performance from an accredited laboratory or third party, where applicable; the list includes:

Part of the plant	Standards listed by WHO (2024)
Electrical components and alarms	IEC 60601-1; IEC 60601-1-8
Filter output	ISO 8573-1, ISO 8573-2, ISO 8573-4 and ISO 8573-5
Piping, hoses and connections	ISO 5359; ISO 7396-1
Air and product tanks	ISO 16528-1 or ASME BPVC Section VIII Division 1; ISO 15001; ASTM G93/G93M-19

The same table asks for a pre-shipment inspection report with all certificates of analysis of product output, technical tests and calibration, and for at least 72 hours of continuous operation to test the whole system before commissioning, with results cross-checked against the pre-shipment inspection.

Verification on site

UNDP makes the supplier responsible for comprehensive testing of the complete plant, requires pre-shipment inspection, performance tests of at least three days of continuous operation, alarm tests and commissioning reports, and encourages its project teams to engage certified third-party organisations, where available, for independent verification and certification. The 2020 WHO interim specification said conformity of installation shall be verified by a certified third party, and a PATH analysis of PSA plant failures (November 2023) recommends an independent inspection after installation by a third party not involved in procurement. A Global Fund post-commissioning assessment form (12 September 2025) is a checklist to confirm that a plant has been correctly installed and is performing optimally, recommended only for staff with the technical skills and tools.

The wider document list, from quality management certificates to market clearance, is on what certificates a PSA supplier should provide.

Ultra Controlo

Ultra Controlo is certified to ISO 13485:2016, and the ULTRAOX SC equipment is parameterised and tested in the factory and ready to start on site (ULTRAOX SC datasheet, p. 3).