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This document specifies requirements and gives recommendations for pre-examination processes for human specimens intended for the detection, differentiation and quantification of infectious pathogens focusing on viruses, bacteria, fungi and parasites. The pre-examination phase includes but is not limited to patient preparation, specimen collection, labelling, handling, transport, processing and storage. It is intended to support but is not limited to molecular, culturing and antigen-based examinations.
This document is applicable to in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health care institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Reģistrācijas numurs (WIID)
83299
Darbības sfēra
This document specifies requirements and gives recommendations for pre-examination processes for human specimens intended for the detection, differentiation and quantification of infectious pathogens focusing on viruses, bacteria, fungi and parasites. The pre-examination phase includes but is not limited to patient preparation, specimen collection, labelling, handling, transport, processing and storage. It is intended to support but is not limited to molecular, culturing and antigen-based examinations.
This document is applicable to in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health care institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
