Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
€128.00
Medical electrical equipment- Part 1-9: General requirements for basic safety and essential performance- Collateral Standard: Requirements for environmentally conscious design
€83.00
Medical electrical equipment- Part 1-10: General requirements for basic safety and essential performance- Collateral Satandard: Requirements for the development of physiologic closed-loop controllers
€91.00
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
€132.00
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
€0.00
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
€58.00
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
€40.00
Nomenclature. Collective terms and codes for groups of medical devices
€193.00
Application of risk management for IT-networks incorporating medical devices. guidance Guidance Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
€404.00
Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
€165.00
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
Medical device software. Software life-cycle processes
Medical devices. Recognized essential principles of safety and performance medical devices General additional specific for all non-IVD guidance on the selection standards
€374.00
Medical electrical equipment Guidance and interpretation. medical systems employing a degree of autonomy
