EN ISO 17511:2003

Reference details

Reference: EN ISO 17511:2003
Official title: In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
Organisation: CEN
Publisher status in source: WithdrawnThis is the status recorded in the source, not a statement that this is the latest edition.
Source access: 19 October 2026

Research and application

Begin with the official scope and the product configuration. The title identifies a subject; it does not establish every product, use condition or legal requirement covered by the publication.

Product research routes

Medical devices
Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls.
In vitro diagnostic products
Specimens, intended purpose and analytical and clinical performance for diagnostic devices and systems.
Measurement, test and laboratory equipment
Measurement function, accuracy claims, electrical safety and the conditions under which results are comparable.

Questions for the evidence file

Intended purpose
Classification rationale
Risk management
Verification and performance evidence
Clinical evidence scope
Assay configuration

Record the exact edition and associated amendments, the assessed object, the evidence examined and the limits of the conclusion. Explore IESQ research for detailed product and standard studies.

Legislation reference records

The following records come from Commission information lists. A source listing, a publication status and a legal presumption of conformity answer different questions. Check the applicable Official Journal acts, dates and restrictions for the intended claim.