ISO 20691:2022

Overview

ISO 20691:2022 - Biotechnology: Requirements for data formatting and description in the life sciences defines a framework for consistent formatting, documentation and metadata for life‑science data. The standard supports making biological data Findable, Accessible, Interoperable and Reusable (FAIR) across manual and automated workflows, covering both primary experimental/procedural records and machine‑derived high‑throughput outputs. It applies across biotechnology and life‑science domains including genomics, transcriptomics, proteomics, metabolomics, synthetic biology, systems biology and related fields.

Key Topics

• Data and metadata formatting requirements: rules for consistent representation of primary and derived data to support reuse and automated processing.
• Identifiers and naming: recommended ubiquitous identifier schemes (URI/IRI provisions) for biological and conceptual entities to ensure stable referencing.
• Data types and encoding: guidance on encoding numerical values, character strings, sequence data, time values, boolean fields and imaging data.
• Versioning and provenance: requirements for version control, change logs and provenance to track data lineage and ensure integrity.
• Validation and integrity: format validation, compression, structural/control elements and data integrity checks for reliable exchange.
• Semantic annotation: minimum consensus information for annotating species, sex, age, organ, tissue, cell type, processes and technologies to enable interoperability.
• Terminologies and ontologies: criteria for ontologies and controlled vocabularies (maintenance, syntax, stable URIs, linking, licensing and community governance).
• Domain‑specific standards & repositories: requirements for maintainers of data standards and repositories, including stability, linking, visibility and governance (see Annexes for examples and minimum reporting standards).

Applications and Who Should Use It

ISO 20691:2022 is designed for practical use by:

• Researchers and laboratory teams capturing experimental metadata and high‑throughput outputs.
• Bioinformaticians and data engineers implementing data models, parsers and pipelines that require consistent encoding and validation.
• Repository managers and data stewards developing submission guidelines, persistent identifiers and discoverability features.
• Standards developers and ontology curators ensuring vocabularies meet interoperability requirements.
• Industry and regulatory bodies seeking reproducible, FAIR‑aligned data management across biotechnology, environmental and agricultural contexts (excluding diagnostic/therapeutic clinical use).

Practical benefits include improved data interoperability, reproducible analyses, easier data sharing, and reduced integration costs across life‑science projects and platforms.

Related Standards

• Aligns with FAIR principles and ISO/IEC directives for standards development.
• Includes informative annexes listing common life‑science formats and minimum reporting standards to support implementation.

Keywords: ISO 20691:2022, data formatting, life sciences, FAIR, metadata, ontologies, repositories, data interoperability, biotechnology.