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AAMI TIR97:2019/(R)2023

Principles for medical device security—Postmarket risk management for device manufacturers

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AAMI TIR97:2019/(R)2023

Principles for medical device security—Postmarket risk management for device manufacturers

PUBLISH DATE 2023

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SDO	AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number	AAMI TIR97
Publication Date	Jan. 31, 2023
Language	en - English
Page Count	56
Revision Level
Supercedes
Committee

Publish Date	Document Id	Type	View
Jan. 31, 2023	AAMI TIR97:2019/(R)2023	Revision

SDO	Document	Title
AAMI	AAMI SW96	Standard for medical device security—Security risk management for device manufacturers
AAMI	AAMI TIR57	Principles for medical device security—Risk management
BSI	BSI BS ISO 16142-2	Medical devices. Recognized essential principles of safety and performance of medical devices -- General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BSI	BSI PD IEC/TR 80001-2-2	Application of risk management for IT-networks incorporating medical devices -- Guidance for the disclosure and communication of medical device security needs, risks and controls
BSI	BSI BS ISO 16142-1	Medical devices. Recognized essential principles of safety and performance of medical devices -- General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
AAMI	ANSI/AAMI/ISO 16142-2	Medical devices—Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BSI	BSI BS EN ISO 14971	Medical devices. Application of risk management to medical devices
ISO	ISO 14971	Medical devices - Application of risk management to medical devices
CSA	CSA ISO 14971	Medical devices – Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12)
BSI	BSI PD IEC/TR 80001-2-1	Application of risk management for IT-networks incorporating medical devices -- Step-by-step risk management of medical IT-networks. Practical applications and examples
AAMI	ANSI/AAMI/ISO 16142-1	Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
AAMI	ANSI/AAMI/IEC TIR80001-2-2	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
IEC	IEC/TR 80001-2-2	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
BSI	BSI PD ISO/TR 11633-2	Health informatics. Information security management for remote maintenance of medical devices and medical information systems -- Implementation of an information security management system (ISMS)
BSI	BSI BS EN ISO 17664-2	Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices -- Non-critical medical devices
AAMI	ANSI/AAMI/IEC TIR80001-2-1	Application of risk management for IT-networks incorporating medical devices—Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples.
IEC	IEC/TR 80001-2-1	Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples
CSA	CSA ISO 17664-2	Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices (Adopted ISO 17664-2:2021, first edition, 2021-02)
AAMI	ANSI/AAMI/ISO 17664-2	Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
ISO	ISO 17664-2	Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
BSI	BSI BS EN ISO 17664-1	Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices -- Critical and semi-critical medical devices
ISO	ISO/TR 11633-2	Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 2: Implementation of an information security management system (ISMS)
BSI	BSI BS EN ISO 10993-18	Biological evaluation of medical devices -- Chemical characterization of medical device materials within a risk management process
BSI	BSI PD ISO/TS 11633-1	Health informatics. Information security management for remote maintenance of medical devices and medical information systems -- Requirements and risk analysis

AAMI TIR97:2019/(R)2023

Principles for medical device security—Postmarket risk management for device manufacturers

AAMI TIR97:2019/(R)2023

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