AAMI Products

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

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

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

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

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

Medical devices—Guidance on the application of ISO 14971

Medical devices—Post-market surveillance for manufacturers

Medical devices—Quality management systems—Requirements for regulatory purposes

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

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

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

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

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

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

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

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

Human factors engineering—Design of medical devices

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

Guidance for logging of alarm system data