Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
€20.00
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
€166.00
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific (ISO 15223 1:2021/Amd 1:2025)
Clinical investigation of medical devices for human subjects - Good clinical practice
€59.00
Medical device traceability enabled by unique device identification (UDI)
€50.00
Nomenclature - Collective terms and codes for groups of medical devices
€0.00
Privacy of monitoring technology - Guidelines for introducing ambient and wearable monitoring technologies balancing privacy protection against the need for oversight and care
€89.00
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
€58.00
Catalogues in maintenance and management of medical devices - Fundamentals
€177.45
Licensing and implementing of new nanotechnologies in the area of medical technology - Fundamentals
€134.70
Systematical development for a model-based testing of medical devices - Fundamentals
€128.28
Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
€201.51
Calibration of measuring equipment for electrical quantities - Test equipment for checking the safety of electrical devices - Electrical devices in medical technology according to DIN EN 62353 (VDE 0751-1)
€103.98
