Medical devices — Application of risk management to medical devices

International Organization for Standardization

Guidance for assessment and evaluation of changes to drug delivery systems

International Organization for Standardization

Medical electrical equipment - ALL PARTS

International Electrotechnical Committee

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

International Electrotechnical Committee

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

International Electrotechnical Committee

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

International Electrotechnical Committee

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

International Electrotechnical Committee

Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

International Electrotechnical Committee

Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

International Electrotechnical Committee

Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers

International Electrotechnical Committee