---
title: ISO Standards
description: "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…"
url: "https://www.clinicalinformatics.nhs.scot/playbook/iso-standards/"
updated: "2024-05-20"
category: Approach
---

# ISO Standards

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](https://www.barbour.info/). 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.**