AAMI Products

Medical device safety assurance case guidance

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

Chemical sterilization and high-level disinfection in health care facilities

Medical device software—Software life cycle processes

Medical device software—Part 2: Validation of software for medical device quality systems

Medical devices—Guidance on the application of ISO 14971

Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Medical devices—Post-market surveillance for manufacturers

Risk management of radio-frequency wireless coexistence for medical devices and systems

Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes

Guidance on the use of AGILE practices in the development of medical device software

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

Ethylene oxide sterilization in health care facilities: Safety and effectiveness

Medical devices—Quality management systems—Requirements for regulatory purposes

Medical Devices—A Practical Guide, Advice from ISO/TC 210

Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software

Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Principles for medical device security—Postmarket risk management for device manufacturers

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities