Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
€51.24
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In-vitro diagnostic (IVD) medical equipment - Matériels électriques de mesure, de commande et de laboratoire
€74.00
Medical devices utilizing animal tissues and their derivatives - Part 3 : validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
€73.30
Performance evaluation of in vitro diagnostic medical devices
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media - Dispositifs médicaux de diagnostic in vitro
€28.00
Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals
€181.00
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1 : broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases - Sensibilité in vitro des agents infectieux et évaluation des performances des dispositifs pour antibiogrammes - Partie 1 : Méthode de référence de microdilution en bouillon pour la détermination de la sensibilité in vitro aux agents antimicrobiens des bactéries aérobies à croissance rapide
€78.00
Clinical investigation of medical devices for human subjects - Good clinical practice - Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques
€159.33
Évaluation biologique des dispositifs médicaux - Partie 15 : identification et quantification des produits de dégradation issus des métaux et alliages
€93.67
Biological evaluation of medical devices - Part 22 : guidance on nanomaterials
€156.67
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
Haemostaseology - Reference method for the ristocetin-cofactor activity of the VWF; Text in German and English
€56.17
Haemostaseology - Reference method for the determination of the collagen binding acitvity of the VWF; Text in German and English
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2009.
€91.03
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2009.
€98.32
