ISO/DIS 22692, Genomics informatics — Quality control metrics for DNA sequencing (40.60)
ISO/DIS 23565, Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cellular therapeutic products (40.60)
ISO/DIS 24934, Genomics informatics — Multi-omics quality control and data integration (40.60)
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 25383, Biotechnology — Single cell sequencing — Part 1: Requirements for data processing of RNA-sequencing for eukaryotic cells (40.20)
ISO/DIS 25448, Microphysiological systems and Organ-on-Chip — Vocabulary (40.20)
ISO/DIS 25802, Biotechnology — Requirements for the production and quality control of immunomagnetic beads (40.20)
ISO/DIS 18209-1, Biotechnology — Biobanking of parasites — Part 1: Helminths (40.20)
ISO/DIS 21709, Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines (40.20)
ISO/DIS 21973, Biotechnology — General requirements for transportation of cellular therapeutic products (40.00)
ISO/DIS 8472-3, Biotechnology — Data interoperability for stem cell data — Part 3: Schema of the database structure (40.00)
ISO/CD 21710, Biotechnology — Specification on data management and publication in microbial resource centers (30.99)
ISO/CD 16921-3, Biotechnology — Gene delivery systems — Part 3: Methods for the quantification and characterization of lipid nanoparticles (30.60)
ISO/CD 20395.2, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR (30.60)
ISO/CD 20399-4, 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)
ISO/CD 25430-1, Biotechnology — Organoids — Part 1: Vocabulary and naming convention (30.60)
ISO/CD 25430-2, Biotechnology — Organoids — Part 2: Manufacturing and quality control of human organoids (30.60)
ISO/CD 25430-3, Biotechnology — Organoids — Part 3: Endpoint quality assessment of human intestinal organoids (30.60)
ISO/CD 25430-4, Biotechnology — Organoids — Part 4: Endpoint quality assessment of human liver organoids derived from pluripotent stem cells (30.60)
ISO/CD 25530, Microphysiological systems and Organ-on-Chip — Quality control and documentation for cellular components (30.60)
ISO/CD 25591, Microphysiological systems and Organ-on-Chip — Digital twins and computational modelling (30.60)
ISO/CD 25693, Microphysiological systems and Organ-on-Chip — Developing process of Organ-on-Chip used for the evaluation of substances (30.60)
ISO/CD 25746, Biotechnology — Bioprocessing — General requirements and considerations for processing decellularized extracellular matrices of soft tissues (30.60)
ISO/CD 8934-2, Biotechnology --Cell viability analytical methods — Part 2: Experimental Designs and Statistical Analysis for Evaluating the Quality of Cell Count-Based Viability Methods (30.60)
ISO/CD TS 25812, Biotechnology — General requirements for performance evaluation of hydrogel materials used in bio-device fabrication (30.20)
IEC/CD TR 63719-1, Medical devices – In silico technologies — Part 1: Terminology and context (30.00)
ISO/WD 26013, Biotechnology — Bioprinting — Requirements for the printing process (20.60)
ISO/WD 12833, Biotechnology — Requirements for RNA quantification methods for gene expression analysis of biological and bioengineered systems (20.60)
ISO/WD 25289, Microphysiological systems and Organ-on-Chip — Key components and minimum requirements for the model of bronchial microphysiological systems (20.60)
ISO/WD 25824, General requirements and considerations for cell-mediated cytotoxicity assays used in characterization and testing of CAR products for therapeutic use (20.20)
ISO/WD 26086, Microphysiological systems and Organ-on-Chip — Guidance for Flow Control (20.20)
ISO/WD 26125-1.2, Biotechnology — Tumorigenicity testing — Part 1: General requirements and considerations for testing of cellular therapeutic products (20.20)
ISO/AWI TS 26899, Biotechnology — In vitro cell culture examinations — Requirements for the application of human plasma to cell models (20.00)
ISO/AWI 5058-1, Biotechnology — Genome editing — Part 1: Vocabulary (20.00)
ISO/AWI TR 26485, Genomics Informatics - Case studies on precision medicine with AI (20.00)
ISO/AWI 26077, Genomics Informatics — General Requirements for Pathogen Genome Reference Database (20.00)
IEC/AWI 63719-2, Medical devices — In silico technologies — Part 2: Credibility assessment of first-principles based methods (20.00)
ISO/AWI 25999, Biotechnology — Search API (Application Programming Interface) for discovery of human biological material and associated data in international biobank networks (20.00)
ISO/AWI 26012, General Requirements and Considerations for AAV Capsid Content Characterization for Gene Therapy (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 20397-1, Biotechnology — NGS — Part 1: Nucleic acid and library preparation (10.99)
ISO/AWI 20397-2, Biotechnology — NGS — Part 2: Quality evaluation of sequencing data (10.99)
ISO/AWI 20397-3, Biotechnology — NGS — Part 3: General requirements and guidance for metagenomics (10.99)
ISO/AWI 22860.3, Biotechnology — Unified Modeling Language (UML) metadata specifications for human mesenchymal stromal cells (10.99)
ISO/AWI 23033-1, Biotechnology – Cell characterization — Part 1: General requirements and considerations for the testing and characterization of cellular therapeutic products (10.99)
ISO/AWI 24866, Biotechnology — Bioprocessing — Information requirements and considerations for single use bag assemblies (10.99)
ISO/AWI 25950, Biotechnology — General considerations and requirements for cryopreservation processes for cellular therapeutic products (10.99)
IEC/AWI 63691-2, Medical devices — In silico technologies — Part 2: Credibility assessment of first-principles based methods (10.99)
ISO/AWI 26032.2, Biotechnology — Nucleic acid-based devices — General requirements for the screening and evaluation of nucleic acid aptamers (10.99)
ISO/AWI 26501, Genomics informatics — Privacy-Preserving Computation on Encrypted Genomic Data using Homomorphic Encryption (10.99)
ISO/AWI 26502, Genomics informatics — Federated Learning Frameworks for Secondary Use of Clinical Genomic Data (10.99)
ISO/AWI 26874-1, Biotechnology — Proteins — Part 1: Terminology (10.99)
ISO/AWI TS 26076, Genomics informatics — General requirements for data elements of peptidomics data (10.99)
ISO/AWI TS 26499, Genomics Informatics — Requirements for data extraction and refinement in AI-assisted precision medicine (10.99)
ISO/NP 25778, Genomics Informatics --Variant QR code in genetic test report (10.60)
ISO/NP 16921-4, Biotechnology — Gene delivery systems — Part 4: General Considerations for Characterization of the Capsid Protein Particle Population in AAV Products (10.60)
ISO/NP 25637.2, Biotechnology — Analytical Methods — Guidelines for the application of whole genome sequencing for genome-wide genetic diversity assessment of higher animals and plants (10.20)
ISO/NP 25848, Biotechnology — Process monitoring in biomanufacturing — Vocabulary (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 20688-3, Biotechnology — Nucleic acid synthesis — Part 3: Screening requirements for ensuring biosafety and biosecurity (00.00)
ISO/PWI 23033-2, Biotechnology —– Cell characterization — Part 2: General requirements and considerations for the testing and characterization of human and mammalian-derived cells and cell lines (00.00)
ISO/PWI 25779, Pedigree – Common Dataset for Family Health History (00.00)
ISO/PWI 25998, Biotechnology - Nucleic acid-based devices - General requirements for the screening and evaluation of nucleic acid aptamers (00.00)
ISO/PWI 26125-2, Biotechnology Tumorigenicity Testing — Part 2: Nucleic Acid Detection for Undifferentiated Pluripotent Stem Cells in cell and gene therapy products (00.00)
ISO/PWI 26630, Biotechnology — General requirements for bioinformatics database design and construction (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 26837, Microphysiological systems and Organ-on-Chip — General requirements for multiple tissues linkage microphysiological systems (00.00)
ISO/PWI 26841, Biotechnology — Analytical methods — General requirements and considerations for the characterization for composition of extracellular vesicles (00.00)
ISO/PWI 26853, Genomics informatics — Data analysis requirements for minimal residual disease assessment by adaptive immune receptor sequencing (00.00)
ISO/PWI 26854, Genomics informatics — Data elements and metadata for assessing gut microbiome modulation in human health (00.00)
ISO/PWI 26855, Genomics informatics — Reference material- based quality management for quantitative multi-omics -General principles (00.00)
ISO/PWI 26856, Genomics informatics — Specifications of Quality Control Metrics for Whole Genome Sequencing (00.00)
ISO/PWI 26860, Biotechnology — Cellular morphological analysis — Part 2: General requirements and considerations for three-dimensional characterization of cells and multi-cellular structures by optical microscopy (00.00)
ISO/PWI 26861, Biotechnology — Analytical methods — Development of reference spectra for microbial species identification by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) (00.00)
ISO/PWI 26863, Method for absolute quantification of RNA-seq using spike-in reference materials with metrological traceability to the SI (00.00)
ISO/PWI 63691-2, Medical devices — In silico technologies — Part 2: Credibility assessment of first-principles based methods (00.00)
