We base our approach to clinical safety on the latest International Organisation for Standardisation (ISO) standards and guidance including:
ISO 14971:2019 – Medical devices – Application of risk management to medical devices
This standard specifies the principles and process for risk management of medical devices, including Software as a Medical Device (SaMD). The risks/hazards identified are evaluated and assessed, and controls identified which are then monitored for their effectiveness in reducing the likelihood of harm occurring to a patient.
The requirements of this standard are applicable to all phases of the life cycle of a medical device. Although the process is defined for medical devices, it can also be applied to digital solutions that are not necessarily medical devices but are used within healthcare.
ISO/TR 24971:2020 Medical Devices - Guidance on Application of ISO 14971:2019
Provides guidance on the development, implementation and maintenance of a risk managemet approach in accordance to ISO 14971:2019.
BS/AAMI 34971:2023 Application of ISO 14971 to machine learning in artificial intelligence
Jointly developed by BSI and US Assocations Advancement of Medical Instrumentation (AAMI), this document complements ISO 14971 providing guidance when evaluating medical devices that use AI and machine learning.
ISO/IEC 42001:2023 Information Technology - Artificial Intelligence - Management system
This document specifies requirements for establishing, implementing, maintaining, and continually improving an Artificial Intelligence Management System (AIMS).
ISO 13485:2016 – Medical devices – Quality Management Systems
This internationally agreed standard sets out the requirements for a quality management system specific to medical devices including Software as a Medical Device (SaMD).
This standard applies to the full life cycle of the product and ensures that processes are in place and best practice is applied and can be evidenced.
ISO 81001-1:2021 – Health software and health IT systems safety, effectiveness, and security
This standard set out the principles, concepts, terms of health software and IT systems. It also incorporates the effectiveness and security across the full life cycle of the product.
IEC 62304:2006 – Medical device software – Software life-cycle processes
This standard sets out the processes, tasks and activities for the life cycle of development of medical device software.
IEC 62366-1:2015 – Application of usability engineering to medical devices
This standard provides a set of processes, activities, and tasks and establishes a common framework for medical device software life cycle development.
Access to ISO documentation is available via the Barbour website. NHS Scotland staff can access doumentation for free with an @nhs.scot email address via the OpenAthens link.
Copyright terms and conditions and restrictions of use apply, so it is essential the agreement is read, understood and agreed before accessing any of the documentation.