Draft BS EN IEC 60601-1/FRAG6 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Electrical hazards (Fragment 6)
€24.00
Draft BS EN IEC 60601-1/FRAG7 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Mechanical hazards (Fragment 7)
Draft BS EN IEC 60601-1/FRAG8 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Thermal fire hazards (Fragment 8)
Draft BS EN IEC 60601-1/FRAG11 Medical electrical equipment Part 1. General requirements for basic safety and essential performance. Electromagnetic exposure hazards (Fragment 11)
BS EN IEC 60601-2-22:2020/prAA:2025 Medical electrical equipment. Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic diagnostic laser equipment
Medical supply units General information
€77.00
Requirements for planning and safety in the multifunctional high-tech working environment surgical theatre/interventional suite
€116.64
Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/DAM 1:2025); German and English version EN ISO 16571:2024/prA1:2025
€34.30
BS EN ISO 16571:2024/Amd 1 Systems for evacuation of plume generated by medical devices. Amendment 1
IEC 61847:2025 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
€302.00
Draft BS EN 63612 Ultrasonics. Intraluminal short pressure pulse therapy sources. Characteristics of fields
Draft BS EN 63521 Machine Learning-enabled Medical Device. Performance Evaluation Process
Évaluation biologique des dispositifs médicaux - Partie 11 : Essais de toxicité systémique
€132.00
Évaluation biologique des dispositifs médicaux - Partie 3 : Évaluation de la génotoxicité, de la cancérogénicité, de la toxicité sur la reproduction et le développement
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
€136.00
