Programme of work

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BUREAU OF INDIAN STANDARDS


Medical Equipment and Hospital Planning Department

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.
  • Liaison :
    ISO/TC 276 - Biotechnology - Participating (P)
    ISO/TC 276/SC 1 - Analytical methods - Participating (P)
    ISO TC 276/SC 2 - Microphysiological systems and Organ-on- Chip - Participating (P)

Published Standards

SI. No.
IS No.
Title
Reaffirmation Details
No. of Amendments
Degree of Equivalence
1.
 IS/ISO/TR 13121:2011
ISO/TR 13121 : 2011
Reviewed In : 2023
Nanotechnologies - Nanomaterial risk evaluation
June, 2023
-
Identical under single numbering
2.
 IS/ISO/TR 17302:2015
ISO/TR 17302:2015
Nanotechnologies Framework for identifying vocabulary development for nanotechnology applications in human healthcare
-
Identical under single numbering
3.
 IS 17707:2021
ISO/TS 22082:2020
Nanotechnologies Assessment of nanomaterial toxicity using dechorionated zebrafish embryo
-
Identical under dual numbering
4.
 IS 17711:2021
ISO 21973:2020
Biotechnology General requirements for transportation of cells for therapeutic use
-
Identical under dual numbering
5.
 IS 18152:2023
ISO/TR 12885:2018
Nanotechnologies Health and safety practices in occupational settings
-
Identical under dual numbering
6.
 IS 18514:2024
ISO 22412:2017
Particle size analysis Dynamic light scattering DLS
-
Identical under dual numbering
7.
 IS 18607:2024
ISO 24421:2023
Biotechnology Minimum requirements for optical signal measurements in photometric methods for biological samples
-
Identical under dual numbering
8.
 IS 18609:2024
ISO 20399:2022
Biotechnology Ancillary materials present during the production of cellular therapeutic products and gene therapy products
-
Identical under dual numbering
9.
 IS 18617:2024
ISO 23033:2021
Biotechnology Analytical methods General requirements and considerations for the testing and characterization of cellular therapeutic products
-
Identical under dual numbering
10.
 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
-
Identical under dual numbering
11.
 IS 18856:2024
ISO 19007:2018
Nanotechnologies In vitro MTS assay for measuring the cytotoxic effect of nanoparticles
-
Identical under dual numbering
12.
 IS 18857:2024
ISO/TR 22019:2019
Nanotechnologies � Considerations for performing toxicokinetic studies with nanomaterials
-
Identical under dual numbering
13.
 IS 18902:2024
ISO/TR 19057:2017
Nanotechnologies �Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability
-
Identical under dual numbering
14.
 IS/ISO 20391-1:2018
ISO 20391-1:2018
Biotechnology Cell counting Part 1: General guidance on cell counting methods
-
Identical under single numbering
15.
 IS/ISO 20391-2:2019
ISO 20391-2:2019
Biotechnology Cell counting Part 2: Experimental design and statistical analysis to quantify counting method performance
-
Identical under single numbering
16.
 IS/ISO 20395:2019
ISO 20395:2019
Biotechnology Requirements for evaluating the performance of quantification methods for nucleic acid target sequences qPCR and dPCR
-
Identical under single numbering
17.
 IS/ISO 20397-1:2022
ISO 20397-1:2022
Biotechnology Massively parallel sequencing Part 1: Nucleic acid and library preparation
-
Identical under single numbering
18.
 IS/ISO 20397-2:2021
ISO 20397-2:2021
Biotechnology Massively parallel sequencing Part 2: Quality evaluation of sequencing data
-
Identical under single numbering
19.
 IS/ISO 20404:2023
ISO 20404:2023
Biotechnology Bioprocessing General requirements for the design of packaging to contain cells for therapeutic use
-
Identical under single numbering
20.
 IS/ISO/TS 20660:2019
ISO/TS 20660 : 2019
Nanotechnologies Antibacterial Silver Nanoparticles Specification of Characteristics and Measurement Methods
-
Identical under single numbering
21.
 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
-
Identical under single numbering
22.
 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
June, 2023
-
Identical under single numbering
23.
 IS/IEC/TS 80004-5:2011
ISO/TS 80004-5 : 2011
Reviewed In : 2024
Nanotechnologies - Vocabulary: Part 5 nano/bio interface
September, 2024
-
Identical under single numbering
24.
 IS/IEC/TS 80004-7:2011
ISO/TS 80004-7 : 2011
Reviewed In : 2024
Nanotechnologies - Vocabulary: Part 7 diagnostics and therapeutics for healthcare
September, 2024
-
Identical under single numbering

Standards Under Develpoment

Projects Approved

SI. No.
Doc No
TITLE
No Records Found

Preliminary Draft Standards

SI. No.
Doc No
TITLE
No Records Found

Drafts Standards in WC Stage

SI. No.
Doc No
TITLE
No Records Found

Draft Standards Completed WC Stage

SI. No.
Doc No
TITLE
1
MHD 20 (27906)
Extracellular Vesicles - Characterization

Finalized Draft Indian Standard

SI. No.
Doc No
TITLE
No Records Found

Finalized Draft Indian Standards under Print

SI. No.
Doc No
TITLE
No Records Found


Aspect Wise Report

 
 Product:   4
 Code of Practices :    6
 Methods of Test :   8
 Terminology :   3
 Dimensions :   0
 System Standard :   0
 Safety Standard :   1
 Others :    0
 Service Specification :    0
 Process Specification :    2
 Unclassified :    0
 


Annexure-I :List of Indian Standards Withdrawn/Superseded

SI. No.
IS No.
Title
1.
 IS/ISO/TR 12885:2008
ISO/TR 12885 : 2008
Reviewed In : 2018
Medical Biotechnology And Medical Nanotechnology
2.
 IS 17647 (Part 1):2021
ISO 20399-1:2018
Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 1 General requirements
3.
 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
4.
 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


Annexure-II :List of Indian Product Standards

SI. No.
IS No. & Year
Title
1.
 IS 18514:2024
ISO 22412:2017
Particle size analysis Dynamic light scattering DLS
2.
 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
3.
 IS/ISO 20404:2023
ISO 20404:2023
Biotechnology Bioprocessing General requirements for the design of packaging to contain cells for therapeutic use
4.
 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