文書番号 | 文書名 | 担当 | 新規登録日 | 現状登録日 | Stage現状 (ISO HPを参照) |
ISO/CD 20691 | Biotechnology — Requirements for data formatting and description in the life sciences for downstream data processing and integration workflows | ISO/TC 276/WG 5 | 2017/8/14 | 2019/10/24 | 30.20 |
ISO/DTS 23565 | Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in manufacturing of cellular therapeutic products | ISO/TC 276/WG 4 | 2018/9/1 | 2021/3/11 | 30.60 |
ISO/WD 24190 | Biotechnology — Analytical Methods — Risk based approach for design and validation of methods for rapid microbial detection in bioprocesses | ISO/TC 276/WG 3 | 2019/6/11 | 2020/6/22 | 20.60 |
ISO/AWI TS 23494-1 | Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements | ISO/TC 276/WG 5 | 2020/5/12 | 2020/5/12 | 20.00 |
ISO/WD 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 | ISO/TC 276/WG 3 | 2020/1/15 | 2020/9/23 | 20.20 |
ISO/CD 24651 | Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow | ISO/TC 276/WG 2 | 2019/10/7 | 2021/1/10 | 30.60 |
ISO/CD 24603 | Biotechnology — Biobanking — Requirements for the establishment, maintenance, characterization and distribution of pluripotent stem cells | ISO/TC 276/WG 2 | 2019/10/7 | 2021/1/6 | 30.60 |
ISO/WD TS 24420 | Biotechnology — Massively parallel DNA sequencing — General requirements for data processing of shotgun metagenomics | ISO/TC 276/WG 5 | 2020/6/22 | 2021/1/29 | 20.20 |
ISO/CD 24088-1 | Biotechnology — Biobanking — Requirements for microorganisms — Part 1: Bacteria and archaea | ISO/TC 276/WG 2 | 2019/10/1 | 2020/12/16 | 30.60 |
ISO/CD 23511 | Biotechnology — General requirements for cell line authentication | ISO/TC 276/WG 3 | 2019/7/2 | 2020/9/25 | 30.60 |
ISO/CD TS 23105 | Biotechnology — Biobanking — Requirements for plant biological material for research and development | ISO/TC 276/WG 2 | 2017/12/15 | 2019/7/8 | 30.00 |
ISO/WD TS 22859 | Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue | ISO/TC 276/WG 2 | 2018/7/9 | 2020/6/23 | 20.60 |
ISO/CD 20399 | Biotechnology — Ancillary materials present during the production of cell and gene therapy products | ISO/TC 276/WG 4 | 2019/11/1 | 2020/9/16 | 30.60 |
ISO/DTS 20388 | Biotechnology — Biobanking — Requirements for animal biological material | ISO/TC 276/WG 2 | 2017/12/14 | 2020/9/26 | 30.60 |
ISO/DIS 5058-1 | Biotechnology — Genome Editing — Part 1: Terminology | ISO/TC 276/WG 1 | 2020/5/12 | 2021/2/23 | 40.60 |
ISO/PWI 24480 | Database validation for nucleic acid sequence evaluation | ISO/TC 276/WG 5 | - | 2019/6/26 | 00.00 |
ISO/PWI 24479 | Biotechnology — Minimum requirements for cell imaging — Image capture, image processing, and cellular morphological analysis | ISO/TC 276/WG 3 | - | 2019/6/26 | 00.00 |
ISO/CD 24421 | Biotechnology — Minimum requirements for optical signal measurements in photometric methods for biological samples | ISO/TC 276/WG 3 | 2020/6/2 | 2021/1/30 | 30.60 |
ISO/PWI TS 23494-2 | Biotechnology — Provenance information model for biological material and data — Part 2: Common provenance model | ISO/TC 276/WG 5 | - | 2020/3/2 | 00.00 |
ISO/FDIS 23033 | Biotechnology — Analytical methods — General guidelines for the characterization and testing of cellular therapeutic products | ISO/TC 276/WG 3 | 2017/11/9 | 2021/3/24 | 50.00 |
ISO 21709:2020/DAmd 1 | Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines — Amendment 1 | ISO/TC 276/WG 2 | 2021/1/14 | 2021/3/19 | 40.20 |
ISO/PWI 20406 | Biotechnology — Bioprocessing — Cell processing management system | ISO/TC 276 | - | 2020/7/14 | 00.00 |
ISO/WD 20404 | Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use | ISO/TC 276/WG 4 | 2020/10/15 | 2020/12/18 | 20.20 |
ISO/DIS 20397-1 | Biotechnology — General requirements for massively parallel sequencing — Part 1: Nucleic acid and library preparation | ISO/TC 276/WG 3 | 2019/6/11 | 2021/2/26 | 40.00 |
ISO/PWI 4752 | Biotechnology — General guidance for microbiological testing for mammalian cell cultures | ISO/TC 276/WG 3 | - | 2019/12/12 | 00.00 |
ISO/PRF TR 3985 | Biotechnology — Data publication — Preliminary considerations and concepts | ISO/TC 276/WG 5 | 2019/10/10 | 2021/3/17 | 50.20 |