Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
€109.00
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)
€133.00
Medical electrical equipment - Part 2-92: Particular requirements for the basic safety and essential performance of magnetic resonance guided radiotherapy equipment for use with external beam equipment
€93.00
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
€113.00
Medical devices — Information to be supplied by the manufacturer
This product is not for sale, please contact us for more information
Clinical evaluation of medical devices
Medical device software - Medical SPICE - Process assessment model - Corrigendum concerning standard VDI 5702 Part 1:2025-05 (Draft)
€0.00
Medical device software - Medical SPICE - Process assessment model
€369.28
Guide for Specifying Carbon-Fiber Randomly Reinforced Ultra-High-Molecular-Weight Polyethylene for Medical Devices (Withdrawn 1992)
Requirements for planning and safety in the multifunctional high-tech working environment surgical theatre/interventional suite
€122.34
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); German and English version EN ISO 15378:2017/prA1:2024
Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Systems for evacuation of plume generated by medical devices (ISO/DIS 16571:2023); German and English version prEN ISO 16571:2023
€140.00