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Standard and/or project under the direct responsibility of ISO/TC 276 Secretariat Stage ICS
ISO/TR 3985:2021
Biotechnology — Data publication — Preliminary considerations and concepts
60.60
ISO 5058-1
Biotechnology — Genome editing — Part 1: Vocabulary
60.00
ISO/AWI 8472-1
Biotechnology — Data interoperability for Stem Cell — Part 1: Framework
10.99
ISO 20387:2018
Biotechnology — Biobanking — General requirements for biobanking
60.60
ISO/PRF TS 20388
Biotechnology — Biobanking — Requirements for animal biological material
50.00
ISO 20391-1:2018
Biotechnology — Cell counting — Part 1: General guidance on cell counting methods
60.60
ISO 20391-2:2019
Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance
60.60
ISO 20395:2019
Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
60.60
ISO/DIS 20397-1
Biotechnology — General requirements for massively parallel sequencing — Part 1: Nucleic acid and library preparation
40.60
ISO 20397-2:2021
Biotechnology — Massively parallel sequencing — Part 2: Quality evaluation of sequencing data
60.60
ISO/TS 20399-1:2018
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
90.92
ISO/TS 20399-2:2018
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 2: Best practice guidance for ancillary material suppliers
90.92
ISO/TS 20399-3:2018
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users
90.92
ISO/CD 20399
Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products
30.60
ISO/CD 20404
Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use
30.60
ISO 20688-1:2020
Biotechnology — Nucleic acid synthesis — Part 1: Requirements for the production and quality control of synthesized oligonucleotides
60.60
ISO/CD 20688-2
Biotechnology — Nucleic acid synthesis — Part 2: General definitions and requirements for the production and quality control of synthesized gene fragment, gene, and genome
30.20
ISO/DIS 20691
Biotechnology — Requirements for data formatting and description in the life sciences
40.20
ISO 21709:2020
Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
90.92
ISO 21709:2020/Amd 1:2021
Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines — Amendment 1
60.60
ISO 21710:2020
Biotechnology — Specification on data management and publication in microbial resource centers
60.60
ISO 21899:2020
Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks
60.60
ISO 21973:2020
Biotechnology — General requirements for transportation of cells for therapeutic use
60.60
ISO/TR 22758:2020
Biotechnology — Biobanking — Implementation guide for ISO 20387
60.60
ISO/DTS 22859
Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue
30.20
ISO 23033:2021
Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products
60.60
ISO/TS 23105:2021
Biotechnology — Biobanking — Requirements for the biobanking of plant biological material for research and development
60.60
ISO/DTS 23494-1
Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements
30.20
ISO/CD 23511
Biotechnology — General requirements for cell line authentication
30.60
ISO/TS 23565:2021
Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use
60.60
ISO/DIS 24088-1
Biotechnology — Biobanking — Requirements for the collection, processing, storage and transportation of microorganisms — Part 1: Bacteria and archaea
40.20
ISO/CD 24190
Biotechnology — Analytical Methods — Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
30.60
ISO/DTS 24420
Biotechnology — Massively parallel DNA sequencing — General requirements for data processing of shotgun metagenomics
30.20
ISO/CD 24421
Biotechnology — Minimum requirements for optical signal measurements in photometric methods for biological samples
30.60
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

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