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Documentary Standards
Documentary standards can specify definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, processes, products, systems, services or practices; test methods and sampling procedures; or descriptions of fit and measurements of size or strength.
NIST Role in Documentary Standards
The National Technology Transfer and Advancement Act (NTAA) directs U.S. agencies to adopt voluntary consensus standards wherever possible, thereby avoiding development of unique government standards, and establishes reporting requirements. In response, NIST coordinates and collaborates with the broader stakeholder community to develop various standards to advance biotechnology and biomanufacturing innovation.
NIST leads or contributes to many American National Standards Institute (ANSI) accredited Standards Development Organizations (SDOs) as well as to other community standards development efforts related to biotechnology. NIST also administers and chairs the US Technical Advisory Group (TAG) to ISO TC 276 Biotechnology. A list of NIST-led standards can be found here.
NIST Engagement in Documentary Standards
NIST engages with a wide range of organizations and committees in the bioscience and health sectors including:
- 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
- Organization for Economic Cooperation and Development (OECD): Test Guidelines Program
NIST also coordinates standards development with professional societies and other organizations including USP, ISCT, ASGCT, AAB and FACTS.
NIST does not endorse any specific standards that may be mentioned herein.