ISO/DTS 8219, Requirements and recommendations for the identification and characterisation of microbes using next generation sequencing directly from clinical specimens in the management of infectious disease (50.00)
ISO/FDIS 20387, Biotechnology — Biobanking — General requirements for biobanks (50.00)
ISO/DIS 25459, In vitro diagnostic medical devices — Requirements for determining commutability of certified reference materials used as secondary calibrators or trueness controls (40.60)
prEN ISO 23640, Medicintekniska produkter för in vitro-diagnostik – Stabilitetsutvärdering av in vitro-diagnostiska reagenser (40.60)
ISO/DIS 23640, In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (40.60)
ISO/DIS 24051-1, Medical laboratories — Part 1: General principles for the application of artificial intelligence in medical laboratories (40.60)
ISO/DIS 21709, Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines (40.20)
ISO/DIS 22859, Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue (40.20)
ISO/DIS 18209-1, Biotechnology — Biobanking of parasites — Part 1: Helminths (40.20)
ISO/DIS 24088-1, Biotechnology — Biobanking of microorganisms — Part 1: Bacteria and archaea (40.20)
ISO/DIS 24603, Biotechnology — Biobanking — Requirements for human and mouse pluripotent stem cells (40.20)
ISO/DIS 24651, Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow (40.20)
ISO/DIS 25379-1, In vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 1: Human DNA examination (40.20)
ISO/DIS 25379-2, In vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 2: Human RNA examination (40.20)
prEN ISO 25379-1, In vitro-diagnostiska arbetsflöden för Next Generation Sequencing (NGS) – Del 1: Undersökning av humant DNA (40.20)
prEN ISO 25379-2, In vitro-diagnostiska arbetsflöden för Next Generation Sequencing (NGS) – Del 2: Undersökning av humant RNA (40.20)
ISO 15195:2018/DAmd 1, Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures — Amendment 1 (40.00)
ISO/DIS 24051-2, Medical laboratories — Part 2: Digital pathology and artificial intelligence (AI)-based image analysis (40.00)
ISO/DIS 21474-4, In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 4: Detection of pathogens (40.00)
ISO/CD 21710, Biotechnology — Specification on data management and publication in microbial resource centers (30.99)
EN ISO 15195:2019/prA1, Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026) (30.99)
prEN ISO 24051-2, Medical laboratories - Part 2: Digital pathology and artificial intelligence (AI)-based image analysis (ISO/DIS 24051-2:2026) (30.99)
ISO/CD 15197, In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (30.60)
ISO/CD 20776-1, Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (30.60)
ISO/CD 25630-1, Biotechnology — Biobanking of organoids — Part 1: General requirements for human intestinal organoids and human intestinal cancer organoids (30.60)
ISO/CD 26358, In vitro diagnostic medical devices — Performance evaluation — Requirements and guidance (30.60)
ISO/CD TR 22758, Biotechnology — Biobanking — Implementation of ISO 20387 (30.60)
ISO/CD TS 16782, Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing (30.60)
ISO/CD TS 25646, In vitro diagnostic medical devices — Definition of analytical performance specifications for laboratory measurements based on medical requirements (30.60)
ISO/WD TS 25725, Design and workflow requirements for in vitro diagnostic next generation sequencing (NGS) based oncology applications (20.60)
ISO/AWI 15190, Medical laboratories — Requirements for safety (20.00)
ISO/AWI 23494-4, Biotechnology — Provenance information model for biological material and data — Part 4: Provenance of data generation (20.00)
ISO/AWI 35001, Biorisk management for laboratories and other related organisations (20.00)
ISO/AWI TS 17849, Guidance on the validation and verification of quantitative and qualitative methods (20.00)
ISO/AWI TS 20776-3, ISO/TS 20776-3, Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — — Part 3: Part 3: Quality performance of disc-diffusion agar method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (20.00)
ISO/AWI TS 24069, Medical laboratories — Guidance for personnel competence and development (20.00)
prEN ISO 26358, In vitro diagnostic medical devices -- Performance evaluation -- Requirements and guidance (10.99)
-, In vitro diagnostic examinations — Specifications for pre-examination processes for human specimens for the detection of infectious pathogens — Viruses, bacteria, fungi and parasites (10.99)
prCEN ISO/TS 17849, Guidance on the validation and verification of quantitative and qualitative methods (10.99)
prCEN ISO/TS 18701, Molecular in vitro diagnostic examinations - Specificationsfor pre-examination processes for human specimens - Isolated microbiome DNA (10.99)
prCEN ISO/TS 18702, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins (10.99)
prEN ISO 15197 rev, In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (10.99)
prEN ISO 18703, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma (10.99)
prEN ISO 20776-1 rev, Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (10.99)
ISO/NP 25724, In vitro diagnostic medical devices — Open-platform PCR examinations for the detection of Mycobacterium tuberculosis and mutations associated with drug resistance-- Requirements for design, development and manufacture (10.20)
ISO/NP 26835-2, Biotechnology — Drug toxicity testing using human organoids — Part 2: Part 2: Quality requirements for human pluripotent stem cell-derived cardiac organoids (10.20)
ISO/PWI 18703, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Isolated circulating cell free RNA from plasma (00.00)
ISO/PWI 20166-1, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA (00.00)
ISO/PWI 20166-2, Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins (00.00)
ISO/PWI 20166-3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA (00.00)
ISO/PWI 20184-1, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA (00.00)
ISO/PWI 20184-2, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins (00.00)
ISO/PWI 20186-1, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA (00.00)
ISO/PWI 20186-2, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA (00.00)
ISO/PWI 20186-3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma (00.00)
ISO/PWI 26832, Biotechnology — Bioprocessing — General requirements for one pot multi-enzymatic catalysis (00.00)
ISO/PWI 26833, Biotechnology — Bioprocessing — General requirements and considerations for bioreactor equipment systems used in the manufacturing of cellular therapeutic products (00.00)
ISO/PWI 26834, Biotechnology — Bio-device for data storage — Part 1: Performance evaluation of materials (00.00)
ISO/PWI 26835-1, Biotechnology — Drug toxicity testing using human organoids — Part 1: General requirements and considerations (00.00)
ISO/PWI TS 18701, Molecular in vitro diagnostic examinations — Specificationsfor pre-examination processes for human specimens — Isolated microbiome DNA (00.00)
ISO/PWI TS 18702, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood — DNA, RNA and proteins (00.00)
