A collection of featured documents from our library that are popular among our users or otherwise noteworthy.
Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
Biological evaluation of medical devices—Part 18: Chemical characterization of materials
Blood Pressure Transducers
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
Disposable ECG electrodes
ECG trunk cables and patient leadwires
Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Amendment 1
Human factors engineering—Design of medical devices
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1
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, Amend. 2
Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
Medical device software—Software life cycle processes
Medical devices—Part 1: Application of usability engineering to medical devices + Amendment 1
Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.
Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
General testing procedures for medical electrical equipment
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization