Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
€50.00
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
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Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements
€107.33
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)
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
€67.00
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
€195.79
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016
€84.58
Biomaterials in medicine - classification,requirements and applications
€128.28
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1 : Application de la gestion des risques
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 2 : contrôles de l’origine, de la collecte et du traitement
€82.00
Medical electrical equipment Guidance and interpretation. Electromagnetic immunity: performance of medical systems
€374.00
€118.00
Application of risk management for IT-networks incorporating medical devices guidance. Guidance on standards establishing the security capabilities identified in IEC TR 80001-2-2
IEC TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
€369.00