BS EN ISO 20184-3:2021

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