Software
14 standards in this category.
| Standard | Title | Scope | GSPR |
|---|---|---|---|
| EN IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes | Software development lifecycle for medical device software | 14, 17, 17.1, 17.2 |
| EN IEC 82304-1:2017 | Health software - Part 1: General requirements for product safety | Product safety requirements for health software products | 17, 17.1, 17.3 |
| IEC 62304:2006+AMD1:2015 | Medical device software — Software life cycle processes | Software development lifecycle for medical devices | 17, 17.1, 17.2, 17.3 |
| IEC 82304-1:2016 | Health software — Part 1: General requirements for product safety | Standalone health software | 17, 17.1, 17.2, 14 |
| AAMI TIR57:2016 | Principles for medical device security—Risk management | Cybersecurity risk management | 17, 17.1, 17.2, 17.3 |
| IEC TR 80002-1:2009 | Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software | Risk management for software devices | 17, 17.1 |
| IEC 81001-5-1:2021 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle | Health software and health IT systems safety, effectiveness and security -- Secu... | 17 |
| IEC/TR 80001-2-2:2012 | 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 | Application of risk management for IT-networks incorporating medical devices -- ... | 17, 17.4 |
| IEC 62443-4-1:2018 | Security for industrial automation and control systems - Part 4-1: Secure product development lifecycle requirements | Security for industrial automation and control systems -- Secure product develop... | 17 |
| ISO 11073-10101:2020 | Health informatics - Device interoperability - Part 10101: Nomenclature | Health informatics -- Device interoperability -- Point-of-care medical device co... | 14, 17 |
| ISO/IEEE 11073-10207:2019 | Health informatics - Device interoperability - Part 10207: Domain information and service model for point-of-care medical device communication | Health informatics -- Personal health device communication -- Domain information... | 14, 17 |
| ISO/IEC TR 24028:2020 | Information technology - Artificial intelligence - Overview of trustworthiness in artificial intelligence | Information technology -- Artificial intelligence -- Overview of trustworthiness... | 17 |
| ISO/IEC 23894:2023 | Information technology - Artificial intelligence - Guidance on risk management | Information technology -- Artificial intelligence -- Guidance on risk management... | 3, 17 |
| EN ISO 11073-10101:2020 | Health informatics - Device interoperability - Part 10101: Nomenclature | Health informatics -- Device interoperability -- Point-of-care medical device co... | 14, 14.5 |