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Committee

Committee:

CTN 129 - Clinical laboratory and in vitro diagnostic systems

Secretary:
FENIN - FEDERACIÓN ESPAÑOLA DE EMPRESAS DE TECNOLOGÍA SANITARIA
Field of Activity:
Standardization of: Clinical laboratory and in vitro diagnostic systems, this includes appropriate equipments in the field of haematology, haemotherapy, clinical chemistry, microbiology, immunology and anatomical pathology, concerning terms and definitions, general characteristics and performance, sterility, test methods, biocompatibility, and biological safety, good manufacturing practices, labelling, packaging and clinical trials. Excluding: Instruments, reagent materials or medical devices, which are within the scope of other technical committees.
Structure:

SC 1 Terminology

SC 2 Quality systems. Reference methods and materials

SC 3 Labelling, containers and packaging. Technical and instrumentation handbooks

SC 4 General techniques for clinical laboratory

International Relations:

ISO/TC 212  Clinical laboratory testing and in vitro diagnostic test systems

CEN/TC 140  In vitro diagnostic medical devices

Standards developed by the committee: CTN 129: 107

UNE-EN ISO 5649:2025

Status: VIGENTE / 2025-09-24

Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)

UNE-ISO/TS 23824:2025 EX

Status: VIGENTE / 2025-09-24

Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology

UNE-ISO/TS 5441:2025 EX

Status: VIGENTE / 2025-09-24

Competence requirements for biorisk management advisors

UNE-EN ISO 18113-1:2025

Status: VIGENTE / 2025-01-22

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)

UNE-EN ISO 18113-2:2025

Status: VIGENTE / 2025-01-22

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)

UNE-EN ISO 18113-3:2025

Status: VIGENTE / 2025-01-22

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)

UNE-EN ISO 18113-4:2025

Status: VIGENTE / 2025-01-22

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

UNE-EN ISO 18113-5:2025

Status: VIGENTE / 2025-01-22

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

UNE-CEN ISO/TS 7552-2:2024 (Ratificada)

Status: VIGENTE / 2024-12-01

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/TS 7552-2:2024) (Endorsed by Asociación Española de Normalización in December of 2024.)

UNE-CEN ISO/TS 7552-1:2024 (Ratificada)

Status: VIGENTE / 2024-12-01

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 1: Isolated RNA (ISO/TS 7552-1:2024) (Endorsed by Asociación Española de Normalización in December of 2024.)

UNE-CEN ISO/TS 7552-3:2024 (Ratificada)

Status: VIGENTE / 2024-12-01

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining (ISO/TS 7552-3:2024) (Endorsed by Asociación Española de Normalización in December of 2024.)

UNE-EN ISO 20916:2024

Status: VIGENTE / 2024-11-27

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

UNE-EN ISO 15189:2023/A11:2024

Status: VIGENTE / 2024-06-19

Medical laboratories - Requirements for quality and competence

UNE-ISO 35001:2021/Amd 1:2024

Status: VIGENTE / 2024-04-03

Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes

UNE-CEN/TS 17981-1:2023 (Ratificada)

Status: VIGENTE / 2024-01-01

In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination (Endorsed by Asociación Española de Normalización in January of 2024.)

UNE-CEN/TS 17981-2:2023 (Ratificada)

Status: VIGENTE / 2024-01-01

In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination (Endorsed by Asociación Española de Normalización in January of 2024.)

UNE-EN ISO 15189:2023

Status: VIGENTE / 2023-01-18

Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

UNE-CEN ISO/TS 5798:2022 (Ratificada)

Status: VALID / 2023-01-01

In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022) (Endorsed by Asociación Española de Normalización in January of 2023.)

UNE-EN ISO 4307:2022

Status: VIGENTE / 2022-09-21

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)

UNE-EN ISO 20776-2:2022

Status: VIGENTE / 2022-09-21

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)

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