Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
€89.33
Biological evaluation of medical devices - Part 18 : chemical characterization of materials
€78.00
Biological evaluation of medical devices - Part 17 : Establishment of allowable limits for leachable substances
Biological evaluation of medical devices - Part 15 : identification and quantification of degradation products from metals and alloys
Biological evaluation of medical devices - Part 14 : identification and quantification of degradation products from ceramics
€65.33
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates - Symbole à utiliser pour l'étiquetage des dispositifs médicaux
€51.24
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials
Health products industries - Guidelines for good manufacturing practices - Synthesis and harmonization of regulatory and normative texts - Industries des produits de la santé
€200.67
Medical electrical equipment - Part 1-6 : general requirements for basic safety and essential performance - Collateral standard : usability
€111.67
Application of risk management for IT-networks incorporating medical devices - Part 1 : roles, responsibilities and activities
€145.67
Nomenclature - Collective terms and codes for groups of medical devices; German version CEN/TR 15133:2005
€56.17
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000 + Amd 1:2004); German version EN ISO 15225:2000 + A1:2004 + A2:2005
€98.32
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004); German version CEN ISO/TR 14969:2005
€173.74
Information supplied by the manufacturer with medical devices; German version EN 1041:1998
€84.58
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2001.
