The German Institute for Standardization has published a new specification that for the first time specifies basic process requirements for quantitative mass spectrometry analyses in medical diagnostic laboratories. DIN SPEC 91532:2026-05 is primarily aimed at methods such as liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) and complements the general quality requirements of DIN EN ISO 15189.

The specification was developed in a consortium led by the LMU Hospital of the Ludwig Maximilian University of Munich, the MVZ Laboratory Dr. Limbach & Kollegen and the Swiss Society for Clinical Chemistry. It follows the PAS procedure and is not part of the German body of standards. The aim is to improve quality assurance in so-called Laboratory Developed Tests (LDTs). These open systems are widely used in routine diagnostics, as fully standardized commercial solutions are still limited. The heterogeneity of the equipment, workflows and personnel qualifications necessitates detailed process specifications that go beyond the general laboratory standards.

DIN SPEC 91532 regulates the selection and documentation of measurement methods, the initial validation and the construction of measurement series, including calibration and quality control samples. Clear acceptance criteria are specified for the release of series and individual results – for example, on calibration function, signal intensities, peak areas of internal standards, ion ratios, retention times, peak shape as well as specificity and interference factors. In addition, long-term processes such as the monitoring of method characteristics across series, the release of new batches of consumables, measures after device interventions and the regular testing of matrix effects are described.

The requirements are deliberately open to technology and also apply to other mass spectrometry methods such as GC-MS. They are intended to give laboratories flexibility in implementing their own work instructions and at the same time strengthen the reliability of results and patient safety. The specification is now available free of charge as a PDF.

Original Paper:

DIN SPEC 91532 – 2026-05 – DIN Media

Editor: X-Press Journalistenbüro GbR

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