BUREAU OF INDIAN STANDARDS
Programme of Work
MHD20 : Medical Biotechnology and Medical Nanotechnology
- Scope : a) Standardization in the field of medical biotechnology, including but not limited to Biobanks and Bioresources, analytical methods (including Chemical and Biological), products (including tissue-engineered medical products), delivery systems, etc. b) Standardization in the field of medical nanotechnology, including but not limited to products, processes and test methods. c) To coordinate with the work of: 1. ISO/TC 276 “Biotechnology” 2. ISO/TC 276/SC 1 “Analytical Methods” 3. ISO/TC 229/WG 3 “Health, Safety & Environmental Aspects of Nanotechnologies”
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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 18856 : 2024 ISO 19007:2018 |
Nanotechnologies In vitro MTS assay for measuring the cytotoxic effect of nanoparticles
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Identical under dual numbering
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IS 18857 : 2024 ISO/TR 22019:2019 |
Nanotechnologies � Considerations for performing toxicokinetic studies with nanomaterials
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Identical under dual numbering
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IS 18902 : 2024 ISO/TR 19057:2017 |
Nanotechnologies �Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability
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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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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 |