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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.10 In vitro diagnostic test systems>20/30408807 DC BS EN ISO 20184-3. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue Part 3. Isolated DNA
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immediate downloadReleased: 2020-08-03
20/30408807 DC BS EN ISO 20184-3. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue Part 3. Isolated DNA

20/30408807 DC

BS EN ISO 20184-3. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue Part 3. Isolated DNA

CURRENCY
LANGUAGE
English
Standard number:20/30408807 DC
Pages:23
Released:2020-08-03
Status:Draft for Comment
DESCRIPTION
This standard 20/30408807 DC BS EN ISO 20184-3. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue is classified in these ICS categories:
  • 11.100.10 In vitro diagnostic test systems

This document gives requirements and 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.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

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.


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