Évaluation biologique des dispositifs médicaux - Partie 6 : essais concernant les effets locaux après implantation
€150.00
Medical devices - Quality management - Medical device nomenclature data structure (ISO/DIS 15225:2015); German and English version prEN ISO 15225:2015
€77.20
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2015); German and English version prEN ISO 15223-1:2015
€116.64
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016.
€173.74
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03); German version EN ISO 15223-1:2016, with CD-ROM
€140.00
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016
€84.58
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016
€0.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
€195.79
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances; German and English version EN 13718-1:2014/prA1:2018
€56.17
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances; German and English version EN 13718-2:2015/prA1:2018
€63.27
Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018
€150.65
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) (ISO/DIS 15378:2016); German and English version prEN ISO 15378:2016
IEC 60601-1:2005/COR1:2006 Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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IEC 60601-1:2005/COR2:2007 Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1:2005/ISH1:2008 Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
