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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Pems related hazards
10.99 New project approved
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Electrical hazards
10.99 New project approved
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Mechanical hazards
10.99 New project approved
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Thermal and fire hazards
10.99 New project approved
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Optical radiation hazards
10.99 New project approved
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
10.99 New project approved
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
10.99 New project approved
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
10.99 New project approved
Medical electrical equipment - Part 2-XX: Particular requirements for the basic safety and essential performance of MRI based image guided radiotherapy equipment for use with electron accelerators
10.99 New project approved
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
10.99 New project approved
Machine learning-enabled medical device - Performance evaluation process
10.99 New project approved
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
10.99 New project approved
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
60.60 Standard published
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
60.60 Standard published
Information supplied by the manufacturer of medical devices
50.60 Close of voting. Proof returned by secretariat