AAMI Products

Risk management guidance for combination products

Water testing methodologies

Washer-disinfectors—Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers

Compatibility of materials subject to sterilization

Microbiological aspects of ethylene oxide sterilization

Flexible and semi-rigid endoscope processing in healthcare facilities

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

Product adoption and process equivalence for ethylene oxide sterilization

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

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

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

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

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 1-12: 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.

Complete Dialysis Collection: 2020 Edition (PDF)

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

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