DIN Standards Committee Health Technologies
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026); German and English version EN ISO 15195:2018/prA1:2026
Abstract
This standard specifies the requirements for the competence to perform reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories so that they can perform their tasks appropriately. Reference laboratories whose test results are presented on nominal and ordinal scales are not within the scope of this standard. This International Standard is not applicable to routine medical laboratories. This document is amendment 1.
Begin
2025-12-05
WI
00140170
Planned document number
DIN EN ISO 15195/A1
Project number
17600219
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices
Responsible international committee
ISO/TC 212/WG 2 - Reference systems
draft standard
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026); German and English version EN ISO 15195:2018/prA1:2026
2026-08
Order from DIN Media
