Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
€50.00
Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
Guidance for assessment and evaluation of changes to drug delivery systems
€163.00
Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995)
Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024); German and English version prEN ISO 20417:2024
€179.53
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
€101.00
Dispositifs médicaux - Informations à fournir par le fabricant
€162.00
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006)
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)
Medical supply units (ISO 11197:2004)
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)
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