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AAMI TIR97:2019 (R2023) Principles For Medical Device Security - Postmarket Risk Management For Device Manufacturers, 2019
- AAMI TIR97:2019/(R)2023; Principles for medical device security—Postmarket risk management for device manufacturers
- Title page
- AAMI Technical Information Report
- Copyright information
- Contents
- Committee representation
- Foreword
- Introduction
- 1 Scope
- 2 Terms and definitions
- 3 Postmarket considerations for security policies and security program administration [Go to Page]
- 4 Design features for postmarket security risk management
- 5 Installation and configuration [Go to Page]
- 6 Postmarket management of fielded devices [Go to Page]
- 7 Retirement/obsolescence [Go to Page]
- Annex A (informative) Sample medical device security policy statements [Go to Page]
- Annex B (informative) Security risk management for healthcare networks [Go to Page]
- Annex C (informative) Establishing a coordinated vulnerability disclosure process [Go to Page]
- Annex D (informative) Mapping of defined terms included in Guidance for Industry and Food and Drug Administration Staff, Postmarket Management of Cybersecurity in Medical Devices [Go to Page]
- Annex E (informative) Security incident handling and response [Go to Page]
- Bibliography [Go to Page]
