Draft BS EN IEC 60601-1/FRAG6 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Electrical hazards (Fragment 6)
€23.00
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 60601-2-36 Medical electrical equipment Part 2-36: Particular requirements for the basic safety and essential performance of extracorporeally induced lithotripsy
Draft BS EN IEC 60050-880/AMD1 ED1 International Electrotechnical Vocabulary (IEV) Part 880: Electrical equipment, electrical systems and software used in healthcare
Évaluation biologique des dispositifs médicaux - Partie 1: Exigences et principes généraux pour l’évaluation de la sécurité biologique au sein d’un processus de gestion des risques
€128.00
Appareils electromedicaux - Partie 2-22 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et de diagnostic à laser
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IEC TR 60601-4-5:2021 Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications
€389.00
IEC TS 60601-4-2:2024 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
IEC TS 60601-4-6:2024 Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
€499.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (CMP)
€156.67
IEC TS 81001-2-2:2025 Health software and health IT systems safety, effectiveness and security - Part 2-2: Coordination - Guidance for the implementation, disclosure and communication of security needs, risks and controls
€302.00
IEC 81001-5-1:2021/ISH1:2025 Interpretation Sheet 1 - Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
ISO TR 24971:2013 Medical devices -- Guidance on the application of ISO 14971
€70.00
ISO TR 80001-2-6:2014 Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
€104.00
