Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016.
€173.74
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
Symboles graphiques pour équipements électriques dans la pratique médicale
€145.67
Évaluation biologique des dispositifs médicaux - Partie 7 : Résidus de stérilisation à l'oxyde d'éthylène
€210.50
Évaluation biologique des dispositifs médicaux - Partie 12 : préparation des échantillons et matériaux de référence - Amendement 1
€52.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)
This product is not for sale, please contact us for more information
Requirements for planning and safety in the multifunctional high-tech working environment surgical theatre/interventional suite
€122.34
Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
€0.00
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
€69.00
Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)
€72.00
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
€114.00
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
€26.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)
€125.00
