AAMI TIR57:2016(R2023)
Current
The latest, up-to-date edition.
Principles for medical device security—Risk management
English
31-01-2023
This Technical Information Report (TIR) provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971.
| DocumentType |
Guide
|
| ISBN |
978-1-57020-612-2
|
| Pages |
84
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ANSI/AAMI/IEC 80001-1:2010 | APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES |
| IEC TS 62443-1-1:2009 | Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models |
| IEC TR 62443-3-1:2009 | Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems |
| IEC TR 80001-2-8:2016 | Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 |
| ISO/IEC 30111:2019 | Information technology — Security techniques — Vulnerability handling processes |
| IEC 62443-2-1:2010 | Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program |
| AAMI IEC TIR 80001-2-2 : 2012 | APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS |
| AAMI IEC 62366-1 : 2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| IEC TR 80001-2-2:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| AAMI ISO 14971 : 2007 : R2010 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| AAMI ISO TIR 24971 : 2013 : R2016 | MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971 |
| IEC 62443-3-3:2013 | Industrial communication networks - Network and system security - Part 3-3: System security requirements and security levels |
| ISO/IEC 29147:2018 | Information technology — Security techniques — Vulnerability disclosure |
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