AAMI Products

Medical devices—Part 1: Application of usability engineering to medical devices, including Amendment 1

Complete Dialysis Collection: 2020 Edition (PDF)

Amendments A1:2020, A2:2020, A3:2020 & A4:2020, Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment & medical electrical systems intended for use in emergency medical services environ.

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

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

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces

Product adoption and process equivalence for ethylene oxide sterilization

Flexible and semi-rigid endoscope processing in healthcare facilities

Water testing methodologies

Compatibility of materials subject to sterilization

Microbiological aspects of ethylene oxide sterilization

Sustainability of medical devices—Elements of a responsible product life cycle