What is ISO 201843 about?
ISO 201843 is one of a series of a document about molecular in vitro diagnostic examinations requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
Note: International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
Who is ISO 20184-3 for?
ISO 20184-3 is useful for:
- Medical laboratories and their customers
- Molecular pathology laboratories that evaluate DNA isolated from frozen tissue.
- Vitro diagnostics developers and manufacturers
- Biobanks, institutions, and commercial organizations performing biomedical research and regulatory authorities
Why should you use ISO 20184-3?
Molecular in vitro diagnostics, including molecular pathology, has enabled significant progress in medicine. ISO 20184-3 provides requirements and recommendations for specimen collection, fresh tissue transports, storage, and transportation for molecular in vitro diagnostic examinations.
ISO 20184-3 outlines the pre-examination process, which precautions should be taken to avoid cross-contamination between different specimens, etc, which helps to ensure that there is no transmission of infectious substances