EN ISO 15195:2019/prA1
(Amendment)Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)
General Information
- Abstract
- Status
- Not Published
- Publication Date
- 23-Mar-2028
- Technical Committee
- CEN/TC 140 - In vitro diagnostic systems
- Drafting Committee
- CEN/TC 140 - In vitro diagnostic systems
- Current Stage
- 3099 - Dispatch of ENQ draft to CMC - Consensus building
- Start Date
- 15-Jun-2026
- Completion Date
- 15-Jun-2026
Overview
EN ISO 15195:2019/prA1 is an amendment to the international standard ISO 15195:2018, addressing requirements for the competence of calibration laboratories in laboratory medicine, specifically those using reference measurement procedures. Published by CEN and developed in collaboration with ISO/TC 212, this standard provides a framework for ensuring precision and competence in measurement laboratories supporting the quality and reliability of laboratory medicine.
This amendment (prA1:2026) clarifies and updates specific requirements to align practices across medical calibration laboratories and to ensure consistency in the implementation of reference measurement procedures in laboratory medicine.
Key Topics
- Calibration Laboratory Competence: Identifies requirements for calibration laboratories operating in the field of laboratory medicine.
- Reference Measurement Procedures: Focuses on laboratories using established reference measurement procedures for calibration.
- Standardized Updates: Amendment 1 brings targeted updates, including specific editorial changes to subclauses for accuracy and clarity.
- Regulatory Alignment: Provides the basis for potential referencing in national or regional regulations and quality control programs.
Applications
The EN ISO 15195:2019/prA1 standard is directly relevant for:
- Accreditation of Calibration Laboratories: Enables laboratories seeking accreditation to demonstrate compliance with international requirements for medical competence.
- Quality Assurance in Laboratory Medicine: Supports laboratories in implementing robust reference measurement procedures, thereby ensuring high quality and traceability of test results.
- Inter-laboratory Comparisons: Facilitates harmonization and comparability of measurement results internationally, which is crucial for patient safety and effective healthcare delivery.
- Regulatory Compliance: Serves as a reference for regulatory authorities and professional bodies involved in oversight of medical laboratory practices.
- Continuous Improvement: Helps laboratories stay up to date with evolving requirements and best practices in measurement calibration.
Related Standards
For a more comprehensive approach to competence and quality in medical laboratories, the following standards are closely related:
- ISO 15189 - Medical laboratories - Requirements for quality and competence
- ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories
- ISO 17511 - Requirements for metrological traceability of values assigned to calibrators and control materials
- EN ISO 15195:2019 - The current version of the standard covering requirements prior to this amendment
Practical Value
Implementing EN ISO 15195:2019/prA1 ensures laboratories in the field of medical calibration benefit from:
- Enhanced Consistency in the execution of reference measurement procedures
- Improved Measurement Accuracy, supporting patient safety and reliable diagnostics
- Recognition and Credibility within the global healthcare and laboratory sector
- Facilitated Audit and Accreditation processes, reinforcing compliance with international and national regulations
By adhering to this amendment, calibration laboratories can effectively maintain high standards in laboratory medicine, align with global best practices, and contribute to the accuracy and reliability of medical testing outcomes.
Relations
- Effective Date
- 03-Dec-2025
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Frequently Asked Questions
EN ISO 15195:2019/prA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)". This standard covers: Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)
EN ISO 15195:2019/prA1 is classified under the following ICS (International Classification for Standards) categories: 11.100.99 - Other standards related to laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 15195:2019/prA1 has the following relationships with other standards: It is inter standard links to EN ISO 15195:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15195:2019/prA1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2026
Laboratorijska medicina - Zahteve za usposobljenost kalibracijskih laboratorijev z
uporabo referenčnih merilnih postopkov - Dopolnilo 1 (ISO 15195:2018/DAM
1:2026)
Laboratory medicine - Requirements for the competence of calibration laboratories using
reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)
Laboratoriumsmedizin - Anforderungen an die Kompetenz von Kalibrierlaboratorien mit
Referenzmessverfahren - Änderung 1 (ISO 15195:2018/DAM 1:2026)
Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage
utilisant des procédures de mesure de référence - Amendement 1 (ISO
15195:2018/DAM 1:2026)
Ta slovenski standard je istoveten z: EN ISO 15195:2019/prA1
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
Amendment
ISO 15195:2018/
DAM 1
ISO/TC 212
Laboratory medicine —
Secretariat: ANSI
Requirements for the competence
of calibration laboratories using
Voting begins on:
2026-07-21
reference measurement procedures
Voting terminates on:
AMENDMENT 1 2026-10-13
Biologie médicale — Exigences relatives à la compétence des
laboratoires d'étalonnage utilisant des procédures de mesure de
référence
AMENDEMENT 1
ICS: 11.100.99
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 15195:2018/DAM 1:2026(en)
DRAFT
ISO 15195:2018/DAM 1:2026(en)
Amendment
ISO 15195:2018/
DAM 1
ISO/TC 212
Laboratory medicine —
Secretariat: ANSI
Requirements for the competence
of calibration laboratories using
Voting begins on:
reference measurement procedures
Voting terminates on:
AMENDMENT 1
Biologie médicale — Exigences relatives à la compétence des
laboratoires d'étalonnage utilisant des procédures de mesure de
référence
AMENDEMENT 1
ICS: 11.100.99
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior writt
...