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A collection of featured documents from our library that are popular among our users or otherwise noteworthy.
Active implantable medical devices— Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
Ethylene oxide sterilization in health care facilities: Safety and effectiveness
Table-top steam sterilizers
Chemical sterilization and high-level disinfection in health care facilities
Processing of reusable surgical textiles for use in health care facilities
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled —sterile—
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
Containment devices for reusable medical device sterilization
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Hospital steam sterilizers
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
Classification of defects in health software
Standard for Medical Device Interoperability
Standard for Risk Concerns for Interoperable Medical Products
Standard for Interoperable Item Development Life Cycle
Standard for Interoperable Item Integration Life Cycle
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
Basic Introduction to the IEC 60601 Series
Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering
Graphic symbols for electrical equipment in medical practice
Medical devices—Part 2: Guidance on the application of usability engineering to medical devices
Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks
Application of risk management for IT networks incorporating medical devices—Part 2-8: Application guidance—Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2