Medical devices utilizing animal tissues and their derivatives Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents validation assays those processes
€269.00
Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases
Medical laboratories. Requirements for safety
€404.00
In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
BS EN ISO 10993-17. Biological evaluation of medical devices Part 17. Toxicological risk assessment device constituents
€23.00
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
€193.00
Guidance for supervisors and operators of point-of-care testing (POCT) devices
€316.00
Medical laboratories. Practical guidance for the estimation of measurement uncertainty
BS ISO 17822-2. In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens Part 2. Laboratory quality practice guide
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated circulating cell free DNA from plasma
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes FFPE tissue Isolated DNA
Specification for single use labelled medical specimen containers for haematology and biochemistry
Specification for cyanmethaemoglobin (haemiglobincyanide) solution for photometric haemoglobinometry
€165.00
Specification for apparatus for measurement of packed red cell volume
