IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
€244.00
Medical device software Part 2: Validation of software for medical device quality systems
€261.00
Application of risk management for IT-networks incorporating medical devices Part 2-6: Application guidance — Guidance for responsibility agreements
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Application of risk management for IT-networks incorporating medical devices — Application guidance Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
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
Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
€259.00
Medical devices — Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements
€225.00
Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system
€50.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
€125.00
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
€69.00
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)
Évaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation - Amendement 1: Modèles supplémentaires d'épiderme humain reconstruit in vitro
€59.00
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied Part 2: Symbol development, selection and validation
€115.00
Medical devices. Quality management systems. Requirements for regulatory purposes
€404.00
