Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection handling
€269.00
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
€374.00
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
€193.00
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated RNA
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated cellular RNA
Molecular in vitro diagnostic examinations. Specifications for pre-examinations processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated proteins
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated DNA
Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
Point-of-care testing (POCT). Requirements for quality and competence
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
Biological evaluation of medical devices Evaluation and testing within a risk management process
€355.00
Single-use containers for human venous blood specimen collection
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process