ISO 17511:2003
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials

Standard No.

ISO 17511:2003

Release Date

2003

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 17511:2020

Latest

ISO 17511:2020

Scope

Water standards specify methods for factory verification of metrological traceability of assigned values to calibrators and control substances based on the establishment or confirmation of measurement accuracy. Calibrators and control substances provided by the manufacturer as part of or used with in vitro diagnostic medical devices, assigned values by an internationally recognized reference measurement system or an internationally recognized agreed reference measurement system, and proven to be non-interchangeable The laboratory quality evaluation samples are applicable to this standard. This standard does not apply to: a) Control substances (precision control substances) that are not assigned a value and are only used to evaluate the precision of a measurement procedure, that is, its repeatability or reproducibility; b) used for quality control in laboratories Controlled substances, such substances have recommended acceptable result value intervals. This interval does not need to be formulated by the laboratory for specific measurement procedure protocols, and its limits are not metrologically traceable; c) At the same measurement level, the same amount of The measurement results of the two measurement procedures are correlated, but such a "level" correlation does not provide traceability; d) Calibration is based on the correlation between the results of the two measurement procedures at different measurement levels, but the measured analyte Characteristics are different; e) Conventional results can be traced to the measurement traceability of product calibrators and their relationship with medical judgment limits; f) Characteristics related to nominal scales, that is, magnitudeless characteristics (such as blood cell classification).

ISO 17511:2003 Referenced Document

• EN 375:2001 Information Supplied by the manufacturer with in Vitro Diagnostic Reagents for Professional Use
• ISO Guide 35:1989 Certification of reference materials - General and statistical principles

ISO 17511:2003 history

• 2020 ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
• 2003 ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials