Medical electrical equipment Guidance and interpretation. for writers of particular standards when creating alarm system-related requirements
€269.00
Guidance for assessment and evaluation of changes to drug delivery systems
€355.00
Medical electrical equipment Particular requirements for basic safety and essential performance of medical robots rehabilitation, assessment, compensation or alleviation
€404.00
Medical devices. Post-market surveillance for manufacturers
€374.00
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements medical systems used in the home healthcare environment
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements the development of physiologic closed-loop controllers
Medical electrical equipment General requirements for basic safety and essential performance. Collateral standard: Usability
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic disturbances. Requirements tests
Medical electrical equipment General requirements for basic safety and essential performance
€383.00
Medical devices Application of usability engineering to medical
Application of risk management for IT-networks incorporating medical devices Safety, effectiveness and security in the implementation use connected or health software
€316.00
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
General testing procedures for medical electrical equipment
Medical electrical equipment Guidance and interpretation. Electromagnetic immunity: performance of medical systems
Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
