What is ISO 21151 about?
ISO 21151 discusses the metrological traceability of values assigned to calibrators and human samples for In vitro diagnostic medical devices (IVDMD). ISO 21151 outlines requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures. And not fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand.
ISO 21151 in cases when certified reference materials or international conventional calibrators exist but are not fit-for-purpose because, for example, they are not commutable with human samples.
Note: ISO 21151 addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.
Who is ISO 21151 for?
ISO 21151 on metrological traceability of values assigned to calibrators and human samples is useful for:
- Biomedical laboratories
- Regulatory authorities
- Notified bodies
Why should you use ISO 21151?
Results for a measurand in a human sample should be numerically equivalent, within clinically meaningful limits, among different laboratories using different in vitro diagnostic (IVD) medical devices (MDs). Clinical practice guidelines for diagnosis and treatment decisions that use fixed decision limits for interpreting laboratory results can only be appropriately applied when results are equivalent irrespective of the IVD MD used.
ISO 21151 guideline provides harmonisation protocol requirements with those includes a description of the measurand, specifications for agreement among results from different IVD MDs, inclusion or exclusion of IVD MDs, harmonization reference materials, Measuring the quantity values of harmonization reference, Modifying the calibration hierarchy for each IVD MD, effectiveness, and sustainability for harmonisation protocols to establish metrological traceability of values assigned to calibrators and human samples. This helps in harmonising the protocols and achieving equivalent results for metrological traceability of values assigned to calibrators and human samples.
