Point-of-care testing (POCT). Requirements for quality and competence
€193.00
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials
In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
€165.00
Biological evaluation of medical devices Tests for in vitro cytotoxicity
Stability testing of in vitro diagnostic reagents
Biological evaluation of medical devices Framework for identification and quantification potential degradation products
Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis management risk
€269.00
Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection handling
Animal tissues and their derivatives utilized in the manufacture of medical devices Validation elimination and/or inactivation viruses transmissible agents
Biological evaluation of medical devices Selection and qualification reference materials for biological tests
Specification for user manuals for in vitro diagnostic instruments for professional use
Biological evaluation of medical devices Tests for local effects after implantation
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
Biological evaluation of medical devices Tests for systemic toxicity
Biological evaluation of medical devices Tests for irritation and sensitization
€316.00
