BUREAU OF INDIAN STANDARDS
Programme of Work
MHD20 : Medical Biotechnology and Medical Nanotechnology
- Scope : To formulate Indian Standard on equipment, nanomaterial for implants, nanotechnology based formulations and delivery systems used in Medical Biotechnology and Medical Nanotechnology.
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Liaison :ISO/TC 276 - Biotechnology - Participating (P)
ISO/TC 276/SC 1 - Analytical methods - Participating (P)
ISO TC 276/WG 2 - Biobanks and bioresources
ISO TC 276/WG 3 - Analytical methods
ISO TC 276/WG 4 - Bioprocessing
ISO TC 229/WG 3 - Health, safety and environmental aspects of nanotechnologies
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IS/ISO/TR 13121 : 2011 ISO/TR 13121 : 2011 Reviewed In : 2023 |
Nanotechnologies - Nanomaterial risk evaluation
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June, 2023
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Identical under single numbering
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IS/ISO/TR 17302 : 2015 ISO/TR 17302:2015 |
Nanotechnologies Framework for identifying vocabulary development for nanotechnology applications in human healthcare
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Identical under single numbering
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IS 17707 : 2021 ISO/TS 22082:2020 |
Nanotechnologies Assessment of nanomaterial toxicity using dechorionated zebrafish embryo
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Identical under dual numbering
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IS 17711 : 2021 ISO 21973:2020 |
Biotechnology General requirements for transportation of cells for therapeutic use
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Identical under dual numbering
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IS 18152 : 2023 ISO/TR 12885:2018 |
Nanotechnologies Health and safety practices in occupational settings
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Identical under dual numbering
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IS 18514 : 2024 ISO 22412:2017 |
Particle size analysis Dynamic light scattering DLS
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Identical under dual numbering
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IS 18607 : 2024 ISO 24421:2023 |
Biotechnology Minimum requirements for optical signal measurements in photometric methods for biological samples
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Identical under dual numbering
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IS 18609 : 2024 ISO 20399:2022 |
Biotechnology Ancillary materials present during the production of cellular therapeutic products and gene therapy products
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Identical under dual numbering
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IS 18617 : 2024 ISO 23033:2021 |
Biotechnology Analytical methods General requirements and considerations for the testing and characterization of cellular therapeutic products
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Identical under dual numbering
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IS 18644 : 2024 ISO/TS 23565:2021 |
Biotechnology Bioprocessing General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use
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Identical under dual numbering
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IS/ISO 20391-1 : 2018 ISO 20391-1:2018 |
Biotechnology Cell counting Part 1: General guidance on cell counting methods
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Identical under single numbering
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IS/ISO 20391-2 : 2019 ISO 20391-2:2019 |
Biotechnology Cell counting Part 2: Experimental design and statistical analysis to quantify counting method performance
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Identical under single numbering
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IS/ISO 20395 : 2019 ISO 20395:2019 |
Biotechnology Requirements for evaluating the performance of quantification methods for nucleic acid target sequences qPCR and dPCR
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Identical under single numbering
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IS/ISO 20397-1 : 2022 ISO 20397-1:2022 |
Biotechnology Massively parallel sequencing Part 1: Nucleic acid and library preparation
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Identical under single numbering
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IS/ISO 20397-2 : 2021 ISO 20397-2:2021 |
Biotechnology Massively parallel sequencing Part 2: Quality evaluation of sequencing data
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Identical under single numbering
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IS/ISO 20404 : 2023 ISO 20404:2023 |
Biotechnology Bioprocessing General requirements for the design of packaging to contain cells for therapeutic use
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Identical under single numbering
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IS/ISO/TS 20660 : 2019 ISO/TS 20660 : 2019 |
Nanotechnologies Antibacterial Silver Nanoparticles Specification of Characteristics and Measurement Methods
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Identical under single numbering
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IS/ISO/TS 23367-1 : 2022 ISO/TS 23367-1:2022 |
Nanotechnologies Performance characteristics of nanosensors for chemical and biomolecule detection Part 1: Detection performance
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Identical under single numbering
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IS/ISO 29701 : 2010 ISO 29701 : 2010 Reviewed In : 2023 |
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (Lal) test
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June, 2023
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Identical under single numbering
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IS/IEC/TS 80004-5 : 2011 ISO/TS 80004-5 : 2011 Reviewed In : 2024 |
Nanotechnologies - Vocabulary: Part 5 nano/bio interface
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September, 2024
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Identical under single numbering
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IS/IEC/TS 80004-7 : 2011 ISO/TS 80004-7 : 2011 Reviewed In : 2024 |
Nanotechnologies - Vocabulary: Part 7 diagnostics and therapeutics for healthcare
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September, 2024
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Identical under single numbering
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MHD 20 (25726)
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Nanotechnologies In vitro MTS assay for measuring the cytotoxic effect of nanoparticles | |
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MHD 20 (25728)
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Nanotechnologies Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability | |
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MHD 20 (25729)
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Nanotechnologies Considerations for performing toxicokinetic studies with nanomaterials |
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IS/ISO/TR 12885 : 2008 ISO/TR 12885 : 2008 Reviewed In : 2018 |
Medical Biotechnology And Medical Nanotechnology |
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IS 17647 (Part 1) : 2021 ISO 20399-1:2018 |
Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 1 General requirements |
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IS 17647 (Part 2) : 2021 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 |
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IS 17647 (Part 3) : 2021 ISO 20399-3:2018 |
Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 3 Best practice guidance for ancillary material users |
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IS 18514 : 2024 ISO 22412:2017 |
Particle size analysis Dynamic light scattering DLS |
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IS 18644 : 2024 ISO/TS 23565:2021 |
Biotechnology Bioprocessing General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use |
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IS/ISO 20404 : 2023 ISO 20404:2023 |
Biotechnology Bioprocessing General requirements for the design of packaging to contain cells for therapeutic use |
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IS/ISO/TS 23367-1 : 2022 ISO/TS 23367-1:2022 |
Nanotechnologies Performance characteristics of nanosensors for chemical and biomolecule detection Part 1 Detection performance |