Standards, Guides and Protocols

The below content is for information only; it does not imply endorsement by NIST.

See ISO TC 276 and ISO TC 276 SC 1 for all completed and developing biotechnology standards.

• ISO 20688-1:2020 – Biotechnology – Nucleic acid synthesis – Part 1: Requirements for the production and quality control of synthesized oligonucleotides
• ISO 20688-2:2024 – Biotechnology – Nucleic acid synthesis – Part 2:  Requirements for the production and quality control of synthesized gene fragments, genes and genomes
• ISO 5058-1:2021 – Biotechnology – Genome editing – Part 1: Vocabulary
• ISO 20395:2019 – Biotechnology – Requirements for evaluating the performance of quantification methods for nucleic acid target sequences – qPCR and dPCR
• ISO 20397-2:2021 – Biotechnology – Massively parallel sequencing – Part 2: Quality evaluation of sequencing data

Please consult The Regenerative Medicine Standards Portal for all completed and developing standards.

• WHO consideration on regulatory convergence of cell and gene therapy products
• ISO 23033:2021 – Biotechnology – Analytical methods – General requirements and considerations for the testing and characterization of cellular therapeutic products
• ASTM F3504-21 – Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method
• ISO 20391-2:2019 – Biotechnology – Cell counting – Part 2: Experimental design and statistical analysis to quantify counting method performance

See ISO TC276 for all completed and developing biobanking standards.

• ISO 20387:2018 – Biotechnology – Biobanking – General requirements for biobanking
• ISO 21709:2020 – Biotechnology – Biobanking – Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines 
• ISO 21899:2020 – Biotechnology – Biobanking – General requirements for the validation and verification of processing methods for biological material in biobanks 

See ISO TC276 for all completed and developing biomanufacturing and bioprocessing standards.

• ISO 20399:2022 – Biotechnology – Ancillary materials present during the production of cellular therapeutic products and gene therapy products
• ISO 21973:2020 – Biotechnology – General requirements for transportation of cells for therapeutic use
• ISO/TS 23565:2021 – Biotechnology – Bioprocessing – General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

Data Standards

• ISO/TS 9491 - 1:2023 – Biotechnology – Predictive computational models in personalized medicine research  – Part 1:  Constructing, verifying and validating models
• ISO 20691:2022 – Biotechnology – Requirements for data formatting and description in the life sciences
• Data File Standard for Flow Cytometry version FCS 3.1
• Synthetic Biology Open Language (SBOL)

• USP Chapter <127> – Flow Cytometric Enumeration of CD34+ Cells
• CLSI H62 – Validation of Assays performed by Flow Cytometry, 1^st Edition

• ISO/DIS 24479 – Biotechnology – Cellular morphological analysis – General requirements and considerations for cell morphometry to quantify cell morphological features
• ASTM F3294-18 – Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy
• ASTM E2719 – Standard Guide for Fluorescence – Instrument Calibration and Qualification

• ASTM E2458-17 – Standard Practices for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents and Toxins from Nonporous Surfaces
• ASTM E2770-17 – Standard Guide for Operational Guidelines for Initial Response to Suspected Biological Agents and Toxins
• ASTM E3095-17 – Standard Guide for Surrogate Materials for Field Evaluation of Nucleic Acid-Based On-Site Biological Assessment Technologies

• ISO 19007:2018 – Nanotechnologies – In vitro MTS assay for measuring the cytotoxic effect of nanoparticles ISO document TC229 Nanotechnologies 2018-04
• ISO 20814:2019 –  Nanotechnologies – Testing the photocatalytic activity of nanoparticles for NADH oxidation