Standard Guides and Protocols

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. ​​​​

• ISO/TC 150/SC 7: Tissue-engineered medical products
• ISO/TC 212: Clinical laboratory testing and in vitro diagnostic test systems
• ISO/TC 229: Nanotechnology
• ISO/TC 276: Biotechnology
• IEC SEG 12: Bio-digital Convergence
• ASTM F04: Medical and Surgical Materials and Devices
• ASTM E54: Homeland Security 
• WHO: International Standards and Reference Panel for anti-SARS-CoV-2 antibody
• Parenteral Drug Association (PDA)
• CLSI: Clinical Standards 
• GA4GH: Global Alliance for Genomics and Health
• Go FAIR

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

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 F2998-14 – Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells
• ASTM F3294-18 – Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy
• An automated protocol for performance benchmarking a widefield fluorescence microscope

• ASTM E2719 – Standard Guide for Fluorescence – Instrument Calibration and Qualification
• IUPAC Technical Report – Characterization of Photoluminescence Measuring Systems
• IUPAC Technical Report – Fluorescence Standards

• 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/TR 16197:2014 – Nanotechnologies – Compilation and description of toxicological screening methods for manufactured nanomaterials
• 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
• Guidance Document on Aquatic (and Sediment) Toxicological Testing of Nanomaterials, OECD (under development)
• Control experiments to avoid artifacts and misinterpretations in nanoecotoxicology testing. NIST Special Publication 1200-11
• Reconstitution of 2 nm diameter Silicon Nanoparticles (RM8027) into aqueous solvents. NIST Special Publication 1200-12
• Measurement of silver nanoparticle dissolution in complex biological and environmental matrices using UV/visible absorbance measurements. NIST Special Publication 1200-13
• Reliable preparation of nanoparticle agglomerates of different sizes in cell culture media. NIST Special Publication 1200-14