DIN EN ISO 18153 2003-11 PDF

Full title and description

STB DIN EN ISO 18153:2003-11 — In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials. The text is the English ISO international title; a German-language national adoption (DIN EN ISO) was published in the European/DIN context in November 2003.

Abstract

This standard specifies how to assure metrological traceability of values assigned to calibrators and control materials intended to establish or verify the trueness of measurement of the catalytic concentration of enzymes in biological samples. It addresses the traceability chain, validation of metrologically traceable calibration, commutability of calibrators and control materials, and related validation topics; certain topics (for example, design of reference procedures, mass-based enzyme quantities, and purely precision control materials) are explicitly excluded.

General information

• Status: Withdrawn (ISO record indicates ISO 18153:2003 has been withdrawn from the ISO catalogue).
• Publication date: ISO original publication August 2003 (approved mid‑2003); adopted as DIN EN ISO 18153 (national/EN adoption) in November 2003 (2003-11).
• Publisher: International standard originally published by ISO (ISO/TC 212); national adoption and publication under the DIN/EN system as DIN EN ISO by Deutsches Institut für Normung.
• ICS / categories: 11.100.10 (In vitro diagnostic test systems / clinical laboratory testing).
• Edition / version: Edition 1 (2003). In the DIN/EN system the designation includes the adoption date element (2003-11).
• Number of pages: ISO edition: 10 pages (ISO bibliographic record); national/EN/DIN published PDFs vary by publisher (commonly listed as 17–19 pages for the EN/DIN formatted version).

Scope

ISO 18153:2003 defines requirements and procedures to ensure metrological traceability of assigned values for calibrators and control materials used with in vitro diagnostic medical devices when measuring catalytic concentrations of enzymes. The standard covers the traceability chain and calibration hierarchy, validation of traceable calibration, analytical specificity considerations, and commutability assessment for calibrators and controls. It excludes requirements for developing or selecting a reference measurement procedure, mass- or immunoreactivity‑based quantities, precision-only control materials (no assigned value), intralaboratory QC materials with consensus limits that are not metrologically traceable, and issues relating to routine result traceability to product calibrators and clinical decision limits.

Key topics and requirements

• Principles of metrological traceability and the structure of a calibration hierarchy (reference measurement procedures → reference materials → calibrators → routine systems).
• Validation of metrologically traceable calibration: documentation, uncertainty assessment and evidence that assigned values are traceable to higher‑order references.
• Analytical specificity: consideration of how measurement procedure specificity affects transfer of traceability and interpretation of assigned values.
• Commutability assessment: requirements and guidance for demonstrating that calibrators and control materials behave like native patient samples across measurement systems.
• Guidance on use of reference measurement procedures and lists (informative annexes may list relevant IFCC primary reference methods for certain enzyme measurands).

Typical use and users

Manufacturers of in vitro diagnostic (IVD) reagents and systems, clinical laboratory metrologists, reference laboratories, accreditation bodies, and regulatory reviewers use this standard to document and evaluate the metrological traceability of assigned values for enzyme catalytic concentration calibrators and control materials. The standard supports activities around calibration evidence, uncertainty statements, and commutability testing used in product dossiers and laboratory quality systems.

Related standards

ISO 18153 is part of the ISO/TC 212 family of standards on metrological traceability and IVDs. Closely related and later, broader standards include ISO 17511 (requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples; revised in 2020) and ISO 21151 (requirements for international harmonisation protocols). These newer publications provide more comprehensive, updated requirements for traceability and harmonisation across IVD measurands.

Keywords

in vitro diagnostic (IVD), catalytic concentration, enzymes, metrological traceability, calibrator, control material, commutability, calibration hierarchy, reference measurement procedure, ISO/TC 212.

FAQ

Q: What is this standard?

A: ISO 18153:2003 provides requirements and guidance for assuring metrological traceability of values assigned to calibrators and control materials specifically for the catalytic concentration of enzymes in biological samples; the national designation appears as DIN EN ISO 18153:2003-11 for the German/EN adoption.

Q: What does it cover?

A: It covers the traceability chain and calibration hierarchy, validation of metrologically traceable calibrations, uncertainty considerations, analytical specificity, and commutability of calibrators and control materials; it also lists exclusions (for example, precision-only control materials and selection of reference procedures).

Q: Who typically uses it?

A: IVD manufacturers, clinical reference laboratories, laboratory metrologists, accreditation bodies and regulators use it when establishing or assessing the traceability of enzyme calibrators and controls.

Q: Is it current or superseded?

A: ISO 18153:2003 is recorded as withdrawn in the ISO catalogue. Traceability requirements for IVD calibrators and control materials have since been consolidated and updated in later documents (for example, ISO 17511 was revised with a new edition published in 2020, and other guidance like ISO 21151 addresses harmonisation protocols). Users should rely on the current ISO/EN/DIN editions (e.g., ISO 17511:2020 and related documents) for up‑to‑date requirements.

Q: Is it part of a series?

A: Yes — it belongs to the family of ISO/TC 212 standards on clinical laboratory testing and in vitro diagnostic devices addressing metrological traceability, calibration and harmonisation (including ISO 17511 and ISO 21151 among others).

Q: What are the key keywords?

A: Enzymes, catalytic concentration, calibrator, control material, metrological traceability, commutability, calibration hierarchy, IVD, reference measurement procedure.