1004 lines
94 KiB
Text
1004 lines
94 KiB
Text
<!DOCTYPE html>
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<html lang="en" dir="ltr" prefix="content: http://purl.org/rss/1.0/modules/content/ dc: http://purl.org/dc/terms/ foaf: http://xmlns.com/foaf/0.1/ og: http://ogp.me/ns# rdfs: http://www.w3.org/2000/01/rdf-schema# schema: http://schema.org/ sioc: http://rdfs.org/sioc/ns# sioct: http://rdfs.org/sioc/types# skos: http://www.w3.org/2004/02/skos/core# xsd: http://www.w3.org/2001/XMLSchema# ">
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<h1 class="nist-page__title">Standards, Guides and Protocols</h1>
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<p><em>The below content is for information only; it does not imply endorsement by NIST.</em></p><div><h2 class="nist-block__title"><span>BIOTECHNOLOGY (selected)</span></h2></div><p><span>See </span><a href="https://www.iso.org/committee/4514241.html"><span>ISO TC 276</span></a><span> and </span><a href="https://www.iso.org/committee/10201756/x/catalogue/p/0/u/1/w/0/d/0"><span>ISO TC 276 SC 1</span></a><span> for all completed and developing biotechnology standards.</span></p><ul><li><a href="https://www.iso.org/standard/68831.html?browse=tc"><span>ISO 20688-1:2020</span></a><span> – Biotechnology – Nucleic acid synthesis – Part 1: Requirements for the production and quality control of synthesized oligonucleotides</span></li><li><a href="https://www.iso.org/standard/75852.html?browse=tc">ISO 20688-2:2024</a> – Biotechnology – Nucleic acid synthesis – Part 2: Requirements for the production and quality control of synthesized gene fragments, genes and genomes</li><li><a href="https://www.iso.org/standard/80679.html?browse=tc"><span>ISO 5058-1:2021</span></a><span> – Biotechnology – Genome editing – Part 1: Vocabulary</span></li><li><a href="https://www.iso.org/standard/67893.html?browse=tc"><span>ISO 20395:2019</span></a><span> – Biotechnology – Requirements for evaluating the performance of quantification methods for nucleic acid target sequences – qPCR and dPCR</span></li><li><a href="https://www.iso.org/standard/67895.html?browse=tc"><span>ISO 20397-2:2021</span></a><span> – Biotechnology – Massively parallel sequencing – Part 2: Quality evaluation of sequencing data</span></li></ul><div><h2 class="nist-block__title"><span>REGENERATIVE MEDICINE (selected)</span></h2></div><p><span>Please consult </span><a href="https://portal.standardscoordinatingbody.org"><span>The Regenerative Medicine Standards Portal</span></a><span> for all completed and developing standards.</span></p><ul><li><span>WHO consideration on </span><a href="https://www.who.int/groups/expert-committee-on-biological-standardization"><span>regulatory convergence of cell and gene therapy products</span></a></li><li><a href="https://www.iso.org/standard/74367.html"><span>ISO 23033:2021</span></a><span> – Biotechnology – Analytical methods – General requirements and considerations for the testing and characterization of cellular therapeutic products</span></li><li><a href="https://www.astm.org/f3504-21.html"><span>ASTM F3504-21</span></a><span> – Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method</span></li><li><a href="https://www.iso.org/standard/67892.html?browse=tc"><span>ISO 20391-2:2019</span></a><span> – Biotechnology – Cell counting – Part 2: Experimental design and statistical analysis to quantify counting method performance</span></li></ul><div><h2 class="nist-block__title"><span>Biobanking (selected)</span></h2></div><p><span>See </span><a href="https://www.iso.org/committee/4514241.html"><span>ISO TC276</span></a><span> for all completed and developing biobanking standards.</span></p><ul><li><a href="https://www.iso.org/standard/68879.html?browse=tc"><span>ISO 20387:2018</span></a><span> – Biotechnology – Biobanking – General requirements for biobanking</span></li><li><a href="https://www.iso.org/standard/71382.html?browse=tc"><span>ISO 21709:2020</span></a><span> – Biotechnology – Biobanking – Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines </span></li><li><a href="https://www.iso.org/standard/72118.html?browse=tc"><span>ISO 21899:2020</span></a><span> – Biotechnology – Biobanking – General requirements for the validation and verification of processing methods for biological material in biobanks </span></li></ul><div><h2 class="nist-block__title"><span>Biomanufacturing (selected)</span></h2></div><p><span>See </span><a href="https://www.iso.org/committee/4514241.html"><span>ISO TC276</span></a><span> for all completed and developing biomanufacturing and bioprocessing standards.</span></p><ul><li><a href="https://www.iso.org/standard/79399.html?browse=tc">ISO 20399:2022</a> – Biotechnology – Ancillary materials present during the production of cellular therapeutic products and gene therapy products</li><li><a href="https://www.iso.org/standard/72326.html?browse=tc"><span>ISO 21973:2020</span></a><span> – Biotechnology – General requirements for transportation of cells for therapeutic use</span></li><li><a href="https://www.iso.org/standard/76053.html?browse=tc"><span>ISO/TS 23565:2021</span></a><span> – Biotechnology – Bioprocessing – General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use</span></li></ul><h2 class="nist-block__title"><span>Data Standards</span></h2><ul><li><a href="https://www.iso.org/standard/83516.html?browse=tc">ISO/TS 9491 - 1:2023</a> – Biotechnology – Predictive computational models in personalized medicine research – Part 1: Constructing, verifying and validating models</li><li><a href="https://www.iso.org/standard/68848.html?browse=tc">ISO 20691:2022</a> – Biotechnology – Requirements for data formatting and description in the life sciences</li><li><a href="https://isac-net.org/page/Data-Standards">Data File Standard for Flow Cytometry version FCS 3.1</a></li><li><a href="https://sbolstandard.org/">Synthetic Biology Open Language (SBOL)</a></li></ul><div><h2 class="nist-block__title"><span>FLOW CYTOMETRY</span></h2></div><ul><li><a href="https://www.usp.org/sites/default/files/usp/document/our-work/biologics/GC-127-CD34.pdf"><span>USP Chapter <127></span></a> – Flow Cytometric Enumeration of CD34+ Cells</li><li><a href="https://clsi.org/standards/products/hematology/documents/h62/">CLSI H62</a> – Validation of Assays performed by Flow Cytometry, 1<sup>st</sup> Edition</li></ul><div><h2 class="nist-block__title"><span>Spectroscopy and MICROSCOPY</span></h2></div><ul><li><a href="https://www.iso.org/standard/78876.html?browse=tc">ISO/DIS 24479</a> – Biotechnology – Cellular morphological analysis – General requirements and considerations for cell morphometry to quantify cell morphological features</li><li><a href="https://www.astm.org/f3294-18.html"><span>ASTM F3294-18</span></a><span> – Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy</span></li><li><a href="https://www.astm.org/Standards/E2719.htm"><span>ASTM E2719</span></a><span> – Standard Guide for Fluorescence – Instrument Calibration and Qualification</span></li></ul><div><h2 class="nist-block__title"><span>BIOTHREAT DETECTION </span></h2></div><ul><li><a href="https://www.astm.org/Standards/E2458.htm"><span>ASTM E2458-17</span></a><span> – Standard Practices for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents and Toxins from Nonporous Surfaces</span></li><li><a href="https://www.astm.org/Standards/E2770.htm"><span>ASTM E2770-17</span></a><span> – Standard Guide for Operational Guidelines for Initial Response to Suspected Biological Agents and Toxins</span></li><li><a href="https://www.astm.org/Standards/E3095.htm"><span>ASTM E3095-17</span></a><span> – Standard Guide for Surrogate Materials for Field Evaluation of Nucleic Acid-Based On-Site Biological Assessment Technologies</span></li></ul><div><h2 class="nist-block__title"><span>NANO-ENVIRONMENTAL HEALTH AND SAFETY</span></h2></div><ul><li><a href="https://www.iso.org/standard/63698.html?browse=tc"><span>ISO 19007:2018</span></a><span> – Nanotechnologies – In vitro MTS assay for measuring the cytotoxic effect of nanoparticles ISO document TC229 Nanotechnologies 2018-04</span></li><li><a href="https://www.iso.org/standard/69298.html"><span>ISO 20814:2019</span></a><span> – Nanotechnologies – Testing the photocatalytic activity of nanoparticles for NADH oxidation</span></li></ul>
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