Human Factors and IT Medical Device Standards at AAMI (2023)

https://doi.org/10.2345/0899-8205-47.s2.37

AAMI HE75, Human factors engineering—Design of medical devices (revision of 2009 edition). Provides detailed human factors engineering (HFE) design guidance to those who are responsible for HFE work within medical device companies.

AAMI TIR50, Post-market surveillance of use error management. Addresses the issue of use error detection for medical devices from the clinical, manufacturer, and regulatory perspective regarding human factors assessment. Provides guidance on how best to collect and leverage post-market use error data to improve product safety and usability.

AAMI TIR51, Guidance for contextual enquiry. Provides guidance on conducting real-world observation of medical procedures in the actual environment of use that is used to provide information for improving procedures, environments, training, and/or devices.

AAMI/IEC 62366-1, Medical devices—Application of usability engineering to medical devices (partial revision of 2007 edition). Specifies a process for a manufacturer to analyze, specify, develop, and evaluate the usability of a medical device as it relates to safety. This usability engineering (UE) or usability HFE process assesses and mitigates risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.

AAMI/IEC 62366:2007/Amendment 1, Medical devices—Application of usability engineering to medical devices, Amendment 1. Addresses legacy devices where the user interface design is of unknown provenance.

AAMI/IEC 62304/Amendment 1, Medical device software—Software lifecycle processes (Amendment to 2006 edition). Includes several matters needing immediate attention, such as the inclusion of software safety classification and legacy software.

AAMI/IEC 62304, Medical device software—Software lifecycle processes (revision of 2006 edition and Amendment 1). Scope expanded from medical device software to health software, with the understanding that medical device software is fully included in health software. Includes primary lifecycle development and maintenance processes, and supporting processes such as software hazard management, documentation, configuration management, verification, and problem resolution. Applies to software that is a stand-alone medical device or an embedded/integral part of the final device, and includes a compliance section based on whether or not the software can cause a hazard or controls risk.

AAMI/IEC 82304-1, Healthcare software systems—Part 1: General requirements. Addresses health software and includes requirements that would be sufficient for software that is a medical device, while not constraining its scope to only those software products that are regulated as medical devices.

AAMI SW92, Integrated and Clinical Systems—Patient Controlled Analgesia (PCA). Includes a definition of the clinical problem, requirements for the integrated clinical system, component and interface specifications, and deployment options to enable safe PCA.

AAMI/IEC TIR80001-2-5, Application of risk management for IT-networks incorporating medical devices—Part 2–5: Guidance on distributed alarm systems. Provides guidance and practical techniques in the application of ANSI/AAMI/IEC 80001-1 for the risk management of distributed alarm systems.

AAMI/IEC TIR80001-2-6, Application of risk management for IT-networks incorporating medical devices—Part 2–6: Guidance for responsibility agreements. Provides guidance on implementing responsibility agreements, which are required in ANSI/AAMI/IEC 80001-1 for the purpose of defining the roles and responsibilities of all relevant stakeholders in the medical IT-network.

AAMI/IEC TIR80001-2-7, Application of risk management for IT-networks incorporating medical devices—Part 2–7: Application Guidance—Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1.

AAMI TIR46, Guidance on health software safety and assurance. Provides recommendations for using quality management principles for health software to improve patient safety. It will also interpret requirements of FDA regulations and international standards when these are required for regulated software.

AAMI TIR47, Guidance on the application of quality management principles to health software. Provides recommendations for using quality management principles for health software to improve patient safety.

AAMI SW91, Classification of defects contributing to unacceptable risk in health software. Provides a common method for classifying defects in health software.

ANSI/AAMI/IEC TIR80002-1:2009, Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software. Provides information useful for the performance of effective software risk management, as part of the overall risk management process for devices containing software, in the context of ISO 14971:2007 and ISO/IEC 62304:2006.

ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT networks incorporating medical devices—Part 1: Roles, responsibilities, and activities. Specifies how to achieve essential properties such as safety, effectiveness, data and system security, and interoperability. It defines responsibilities for parties engaged in installing, using, reconfiguring, maintaining, and decommissioning IT-networks incorporating medical devices. Also addresses risks related to patients, operators, and/or third parties.

ANSI/AAMI/IEC TIR80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices—Part 2–1: Step by step risk management of medical IT-networks; Practical application and examples. All relevant requirements in ANSI/AAMI/IEC 80001-1 are addressed and links to other clauses and subclauses of ANSI/AAMI/IEC 80001-1 are addressed where appropriate.

ANSI/AAMI/IEC TIR80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices—Part 2–2: Guidance for the communication of medical device security needs, risks and controls. Creates a framework for the disclosure of security-related capabilities and risks necessary for managing risk in connecting medical devices to IT-networks and for the security dialog that surrounds ANSI/AAMI/IEC 80001-1.

ANSI/AAMI/IEC TIR80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices—Part 2–3: Guidance for wireless networks. Supports the healthcare delivery organization (HDO) in the risk management of medical IT-networks that incorporate one or more wireless links, considers the use of wirelessly networked medical devices on a medical IT-network, and offers practical techniques to address the unique risk management requirements of operating wirelessly enabled medical devices in a safe, secure, and effective manner.

ANSI/AAMI/IEC TIR80001-2-4:2012, Application of risk management for IT-networks incorporating medical devices—Part 2–4: General implementation guidance for healthcare delivery organizations. Provides guidance in establishing a risk management framework prior to embarking on a detailed risk assessment of an individual instance of a medical IT-network.

AAMI TIR36:2007, Validation of software for regulated processes. Applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling, or to automate any other aspect of the quality system as defined by the Quality System Regulation (21 CFR 820). Also applies to software used to create, modify, and maintain electronic records and to manage electronic signatures that are subject to the validation requirements (21 CFR 11).

ANSI/AAMI SW87:2012, Application of quality management system concepts to medical device data systems. Provides information that allows the medical device data system manufacturer to implement a quality management system that is commensurate with the risk presented by the device, the complexity of device and manufacturing processes, and the size and complexity of organization.

AAMI TIR45:2012, Guidance on the use of agile practices in the development of medical device software. Provides recommendations for complying with international standards and FDA guidance documents when using agile practices to develop medical device software.

AAMI TIR32:2004, Medical device software risk management. Provides information useful to performing effective software risk management.

Copyright: © 2013 Association for the Advancement of Medical Instrumentation. Publishing services provided by Allen Press, Inc.

2013