What is ISO 17511 about?
ISO 17511 addresses In vitro diagnostic medical devices and specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials, and human samples for quantities measured by IVD MDs.
The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).
Note: Nominal scales are typically used to report e.g., the identity of blood cell types, microorganism types, the identity of nucleic acid sequences, the identity of urine particles. Ordinal scales are often applied to results differentiated into dichotomous groupings (e.g., ‘sick’ vs. ‘healthy’), and occasionally to results differentiated into non-dichotomous categories where the result categories are rank-ordered but the rank-ordered categories cannot be differentiated in terms of the relative degree of difference, e.g., negative, +1, +2, +3 for grading of the presence of haemoglobin in urine specimens by visual observation.
Who is ISO 17511 for?
ISO 17511 is applicable to-
- Medical and calibration laboratories
- Manufacturers of IVD MDs
- RMP developers and RM producers
Why should you use ISO 17511?
ISO 17511 helps you in examining a measured in a human sample and to produce laboratory results that will enable a clinician to assess the risk of a disease or to diagnose and make treatment decisions for a medical condition. This helps in producing equivalent results which allow uniform application of medical decision limits and reference intervals, which can reduce the risk of harm caused by medical decisions based on non-equivalent examination results.
ISO 17511 helps in meeting General requirements that should be fulfilled by the manufacturer for establishing, validating, and documenting metrological traceability of human sample values determined with a specified IVD MD. It is useful for model calibration hierarchies for metrological traceability.
What’s changed since the last update?
BS EN ISO 17511:2021 supersedes ISO 17511:2021, which has been withdrawn. BS EN ISO 17511:2021 Has some significant technical changes with respect to ISO 17511:2021, these include:
- Incorporation of the special requirements for metrologically traceable calibration hierarchies for measurement of catalytic concentration of enzymes (previously covered in ISO 18153:2003)
- To clarify that final reported values on human samples shall be metrologically traceable to the highest order available reference, the title and scope were modified to include metrological traceability of values assigned to human samples
- Updated normative references to remove International Vocabulary of Basic and General Terms in Metrology, 2nd edition, ISO, Geneva (1993) and ISO Guide 35:1989, Certification of reference materials — General and statistical principles
- Revision of clause 4 to clearly define requirements of a manufacturer of an in vitro diagnostic medical device in establishing and documenting metrological traceability of assigned values (for calibrators, trueness controls, and human samples), while incorporating requirements previously addressed in Clauses 6, 7, and 8 (thus eliminating those sections
- Revision of Clause 5 to incorporate additional models of metrologically traceable calibration hierarchies, especially 5.3 for measurement of catalytic concentration of enzymes (where the measurand is defined by a primary RMP; previously addressed in ISO 18153:2003), and 5.6 for an overview of the concept of assigned values of materials for measurands with metrological traceability to international harmonisation protocols (addressed in detail in ISO 21151).