Ämnesområden

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 17 okt 2020
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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.

Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 15 nov 2020
Se merSe mindre
 

This standard specifies requirements and test methods for single-use evacuated and non-evacuated receptacles, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. NOTE 1 Requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers are specified in EN ISO 6710. NOTE 2 While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened, this standard does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test. This standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.