BBD staff actively participate in and lead the development of Documentary Standards through standards developing organizations (SDOs). NIST administers and chairs the US Technical Advisory Group (TAG) to ISO/TC 276: Biotechnology.
We engage with the following standards organizations and committees in the biosciences and health sectors.
We also coordinate standards development with professional societies and other organizations such as USP, ISCT, ASGCT, AABB, and FACTS.
The below content is for information only; it does not imply endorsement by NIST.
See ISO TC276 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 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
REGENERATIVE MEDICINE (selected)
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/TS 20399-1:2018 – Biotechnology – Ancillary materials present during the production of cellular therapeutic products – Part 1: General requirements
- 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
- ISO/TS 20399-3:2018 – Biotechnology – Ancillary materials present during the production of cellular therapeutic products – Part 3: Best practice guidance for ancillary material users
- 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
- Validation of Cell-based Fluorescence Assays: Practice Guidelines from the International Council for Standardization of Haematology and International Clinical Cytometry Society. Cytometry part B (Clinical Cytometry) 84B Issue 5, (2013) An ICSH/ICCS Workgroup Special Issue: (B.H. Davis, et al. Contributed to by Lili Wang, NIST)
- 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
NANO-ENVIRONMENTAL HEALTH AND SAFETY