Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation - Document d'orientation sur la relation entre l'EN ISO 13485:2016 (Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires) et le Règlement européen relatif aux dispositifs médicaux ainsi que le Règlement relatif aux dispositifs médicaux de diagnostic in
€163.33
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101 : safety requirements for in vitro diagnostic (IVD) medical equipment
€95.67
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
€125.67
Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management process - Évaluation biologique des dispositifs médicaux - Partie 1 : Évaluation et essais au sein d'un processus de gestion du risque
€128.67
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1 : isolated RNA
€83.67
Molecular in vitro diagnostic examinations Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2 : isolated proteins
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3 : isolated DNA - Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) - Partie 3 : ADN extrait
€73.00
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1 : isolated RNA
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2 : isolated proteins
€73.23
Point-of-care testing (POCT) - Requirements for quality and competence
€32.67
Biological evaluation of medical devices - Part 4 : Selection of tests for interactions with blood
€159.33
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing - Dispositifs médicaux de diagnostic in vitro
€58.33
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing - Dispositifs médicaux de diagnostic in vitro
€70.75
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use - Dispositifs médicaux de diagnostic in vitro
€51.24
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use - Dispositifs médicaux de diagnostic in vitro
€64.01
