MHD 20  New Standards List


Total Standards :  13

S.No IS Number IS Title Aspect Degree of Equivalence
(E)
Date of Pub.
(F)
Document Action
1 IS 18514 : 2024
ISO 22412:2017
Particle size analysis Dynamic light scattering DLS Product Specification Identical under dual numbering 01-03-2024
2 IS/ISO/TR 17302 : 2015
ISO/TR 17302:2015
Nanotechnologies Framework for identifying vocabulary development for nanotechnology applications in human healthcare Terminology Identical under single numbering 09-04-2024
3 IS 18607 : 2024
ISO 24421:2023
Biotechnology Minimum requirements for optical signal measurements in photometric methods for biological samples Process Specification Identical under dual numbering 09-04-2024
4 IS 18617 : 2024
ISO 23033:2021
Biotechnology Analytical methods General requirements and considerations for the testing and characterization of cellular therapeutic products Methods of tests Identical under dual numbering 09-04-2024
5 IS/ISO 20391-1 : 2018
ISO 20391-1:2018
Biotechnology Cell counting Part 1: General guidance on cell counting methods Code of Practice Identical under single numbering 09-04-2024
6 IS/ISO 20391-2 : 2019
ISO 20391-2:2019
Biotechnology Cell counting Part 2: Experimental design and statistical analysis to quantify counting method performance Methods of tests Identical under single numbering 09-04-2024
7 IS/ISO 20397-1 : 2022
ISO 20397-1:2022
Biotechnology Massively parallel sequencing Part 1: Nucleic acid and library preparation Methods of tests Identical under single numbering 09-04-2024
8 IS/ISO 20397-2 : 2021
ISO 20397-2:2021
Biotechnology Massively parallel sequencing Part 2: Quality evaluation of sequencing data Code of Practice Identical under single numbering 09-04-2024
9 IS/ISO 20404 : 2023
ISO 20404:2023
Biotechnology Bioprocessing General requirements for the design of packaging to contain cells for therapeutic use Product Specification Identical under single numbering 09-04-2024
10 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 Product Specification Identical under single numbering 09-04-2024
11 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 Product Specification Identical under dual numbering 07-05-2024
12 IS/ISO 20395 : 2019
ISO 20395:2019
Biotechnology Requirements for evaluating the performance of quantification methods for nucleic acid target sequences qPCR and dPCR Methods of tests Identical under single numbering 07-05-2024
13 IS 18609 : 2024
ISO 20399:2022
Biotechnology Ancillary materials present during the production of cellular therapeutic products and gene therapy products Code of Practice Identical under dual numbering 07-05-2024