Subcommittee Subcommittee Title Published standards Standards under development
ISO/TC 276/SC 1 Analytical methods 18 15
ISO/TC 276/SC 2 Microphysiological systems and Organ-on-Chip 0 6
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Standard and/or project under the direct responsibility of ISO/TC 276 Secretariat Stage ICS
Biotechnology — Data publication — Preliminary considerations and concepts
60.60
Biotechnology — Data interoperability for stem cell data — Part 1: Framework
60.60
Biotechnology — Data interoperability for stem cell data — Part 2: Key characteristics of stem cell data
60.60
ISO/CD 8472-3 [Under development]
Biotechnology — Data interoperability for stem cell data — Part 3: Schema of the database structure
30.60
Biotechnology — Predictive computational models in personalized medicine research — Part 1: Constructing, verifying and validating models
95.99
Biotechnology — Predictive computational models in personalized medicine research — Part 1: Constructing, verifying and validating models
60.60
ISO/DTS 9491-2 [Under development]
Biotechnology — Predictive computational models in personalized medicine research — Part 2: Requirements and recommendations for implementing computational models in clinical integrated decision support systems
50.20
Biotechnology — Biobanking — Requirements for human neural stem cells derived from pluripotent stem cells
60.60
Biotechnology — Biobanking of parasites — Part 1: Helminths
90.92
ISO/DIS 18209-1 [Under development]
Biotechnology — Biobanking of parasites — Part 1: Helminths
40.00
Biotechnology — Biobanking — Requirements for human natural killer cells derived from pluripotent stem cells
60.60
Biotechnology — Biobanking — Requirements for primary containers for storing biological materials in biobanks
60.60
Biotechnology — Biobanking — Requirements for deep-sea biological material
60.60
Biotechnology — Biobanking — General requirements for biobanking
90.92
ISO/FDIS 20387 [Under development]
Biotechnology — Biobanking — General requirements for biobanks
50.00
Biotechnology — Biobanking — Requirements for animal biological material
90.93
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
95.99
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 2: Best practice guidance for ancillary material suppliers
95.99
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users
95.99
ISO/CD 20399-4 [Under development]
Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products — Part 4: Requirements for the certificate of analysis and the certificate of origin
30.60
Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products
60.60
Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use
60.60
Biotechnology — Requirements for data formatting and description in the life sciences
60.60
Biotechnology — Bioprocessing — General requirements for bacteriophage preparation for therapeutic use
60.60
Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
90.92
Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines — Amendment 1
60.60
ISO/DIS 21709 [Under development]
Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
40.00
Biotechnology — Specification on data management and publication in microbial resource centers
90.92
ISO/CD 21710 [Under development]
Biotechnology — Specification on data management and publication in microbial resource centers
30.99
Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks
90.60
Biotechnology — General requirements for transportation of cells for therapeutic use
90.92
ISO/WD 21973 [Under development]
Biotechnology — General requirements for transportation of cellular therapeutic products
20.20
Biotechnology — Biobanking — Implementation guide for ISO 20387
90.92
ISO/CD TR 22758 [Under development]
Biotechnology — Biobanking — Implementation guide for ISO 20387
30.20
Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue
90.92
ISO/DIS 22859 [Under development]
Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue
40.00
Biotechnology — Biobanking — Requirements for the biobanking of plant biological material for research and development
90.93
Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements
60.60
Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements
95.99
Biotechnology — Provenance information model for biological material and data — Part 2: Common provenance model
60.60
ISO/DIS 23494-3 [Under development]
Biotechnology — Provenance information model for biological material and data — Part 3: Provenance of biological material
40.60
Biotechnology — General requirements and considerations for cell line authentication
90.92
ISO/DIS 23565 [Under development]
Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cellular therapeutic products
40.20
Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use
90.92
ISO/FDIS 24031 [Under development]
Biotechnology — General requirements for nucleic acid- and protein-based bio-devices
50.00
Biotechnology — Biobanking of microorganisms — Part 1: Bacteria and archaea
90.92
ISO/DIS 24088-1 [Under development]
Biotechnology — Biobanking of microorganisms — Part 1: Bacteria and archaea
40.00
Biotechnology — Massively parallel DNA sequencing — General requirements for data processing of shotgun metagenomic sequences
90.20
Biotechnology — Validation of database used for nucleotide sequence evaluation
60.60
Biotechnology — Biobanking — Requirements for human and mouse pluripotent stem cells
90.92
ISO/DIS 24603 [Under development]
Biotechnology — Biobanking — Requirements for human and mouse pluripotent stem cells
40.00
Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow
90.92
ISO/DIS 24651 [Under development]
Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow
40.00
ISO/FDIS 24952 [Under development]
Biotechnology — Biobanking — General requirements for (semi-)automated storage and retrieval equipment
50.00
ISO/DIS 25347 [Under development]
Biotechnology — Bioprocessing — General requirements for the purification of extracellular vesicles
40.60
ISO/DIS 25383 [Under development]
Biotechnology — Single cell sequencing — Part 1: Requirements for data processing of RNA-sequencing for eukaryotic cells
40.00
ISO/WD 25430-1 [Under development]
Biotechnology — Organoids — Part 1: Vocabulary
20.60
ISO/CD 25430-2 [Under development]
Biotechnology — Organoids — Part 2: Manufacturing and quality control of human organoids
30.20
ISO/CD 25430-3 [Under development]
Biotechnology — Organoids — Part 3: Endpoint quality assessment of human intestinal organoids
30.20
ISO/WD 25430-4 [Under development]
Biotechnology — Organoids — Part 4: Endpoint quality assessment of human liver organoids derived from pluripotent stem cells
20.60
ISO/CD 25630-1 [Under development]
Biotechnology — Biobanking of organoids — Part 1: General requirements for human intestinal organoids and human intestinal cancer organoids
30.20
ISO/CD 25746 [Under development]
Biotechnology — Bioprocessing — General requirements and considerations for processing decellularized extracellular matrices of soft tissues
30.20
ISO/DIS 25802 [Under development]
Biotechnology — Requirements for the production and quality control of immunomagnetic beads
40.00
ISO/WD TS 25812 [Under development]
Biotechnology — General requirements for performance evaluation of hydrogel materials used in bio-device fabrication
20.60
ISO/AWI 25999 [Under development]
Biotechnology — Search API (Application Programming Interface) for discovery of human biological material and associated data in international biobank networks
20.00
ISO/WD 26013 [Under development]
Biotechnology — Bioprinting — Requirements for the printing process
20.60
IEC/CD TR 63691-1 [Under development]
Medical devices – In silico technologies — Part 1: Terminology and context
30.00
IEC/AWI 63739-2 [Under development]
Medical devices — In silico technologies — Part 2: Credibility assessment of first-principles based methods
20.00

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