Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
€89.00
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
€20.00
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
€50.00
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 — 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
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
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
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)
Information supplied by the manufacturer of medical devices
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995)
