AAMI Products

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

Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters

Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied—Part 2: Symbol development, selection and validation

Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Compatibility of materials subject to sterilization

Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

Evaluation of particulate associated with vascular medical devices

Water for the reprocessing of medical devices

Design of training and instructional materials for medical devices used in non-clinical environments

Basic Introduction to the IEC 60601 Series

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

Guidance for logging of alarm system data

Integrating human factors into design controls

Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements

Human factors engineering—Design of medical devices

Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products

Principles for medical device security—Risk management