Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements
€374.00
Medical electrical equipment General requirements for safety. Collateral standard. Usability
€404.00
Global medical device nomenclature for the purpose of regulatory data exchange
Graphical symbols for use in the labelling of medical devices
€193.00
Medical electrical equipment General requirements for safety
Medical electrical equipment General requirements for basic safety and essential performance. Collateral standard. Requirements medical systems used in the home healthcare environment
Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
Medical electrical equipment. General requirements for safety Collateral standard. Electromagnetic compatibility. Requirements and tests
Medical devices. Quality management. Medical device nomenclature data structure
€269.00
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
Medical electrical equipment General requirements for safety Collateral standard. requirements, tests and guidance alarm systems in medical
Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air
Medical vehicles and their equipment. Air ambulances Operational technical requirements of air
€316.00
Symbols for use in the labelling of medical devices
Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices