Overview
ISO 20184-3:2021 - "Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA" defines requirements and recommendations for the handling, storage, processing and documentation of frozen tissue specimens when the intended analyte is isolated DNA. It standardizes the pre-examination phase (from specimen collection and transport to DNA isolation) to protect DNA integrity and support reliable molecular in vitro diagnostic examinations, including laboratory‑developed tests and molecular pathology workflows. Note: tissues chemically stabilized before freezing are excluded.
Key topics and technical requirements
- Scope and applicability: Applies to medical and molecular pathology laboratories, biobanks, IVD developers, research organizations and regulatory authorities involved with DNA from frozen tissue.
- Pre-examination workflow: Defines the sequence from examination request, patient/specimen information, collection, transport, reception, sample selection and processing up to start of analytical examination.
- Specimen collection & transport: Requirements for documenting donor and specimen data, cold ischemia considerations and preparation/conditions for safe transport of fresh tissue to freezing.
- Freezing and storage: Procedures and documentation for freezing of specimens and samples and for defined storage conditions to preserve DNA stability. (The standard also defines room temperature as 18 °C–25 °C for context.)
- DNA isolation: Requirements and recommendations for isolating DNA from frozen tissue, including use of commercial kits or laboratory‑developed protocols.
- Quality and quantity assessment: Guidelines for assessing DNA integrity, concentration and suitability for downstream molecular assays.
- Storage of isolated DNA: Recommendations for storage and record‑keeping for isolated DNA to ensure traceability and stability.
- Documentation, verification and validation: Emphasis on records, validation/verification of processes and conformity with laboratory quality and safety norms.
Practical applications and users
- Who uses it: Clinical laboratories, molecular pathology units, hospital labs performing molecular diagnostics, biobanks, IVD manufacturers, research institutes and regulatory bodies.
- Why adopt it: To minimize pre-analytical variability, protect DNA integrity, improve reproducibility of molecular tests (NGS, PCR, etc.), ensure traceability and support regulatory compliance and inter‑laboratory comparability.
- Typical use cases: Standardizing tissue collection and freezing workflows for genomic testing, harmonizing biobank specimen handling for research, validating laboratory‑developed DNA assays, and preparing documentation for accreditation or regulatory review.
Related standards
- ISO 15189 (Medical laboratories - Requirements for quality and competence)
- ISO 15190 (Medical laboratories - Requirements for safety)
- ISO 20184 series (other parts covering pre-analytical processes)
- ISO 20387 (biobanking) and ISO 22174 (nucleic acid terminology)
Adopting ISO 20184-3:2021 helps organizations performing molecular in vitro diagnostic examinations from frozen tissue achieve consistent, documented, and high-integrity DNA sample workflows.