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Medical Device Software Medical device software standards address the development of and risk management for the intersection between medical devices and software that is an embedded or integral part of the final medical device. Essentially, with both medical devices and software individually greatly benefiting from standardization, the benefits are further compounded when development of both is part of a single project.

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ISO/IEC 24791-5:2012

Information technology - Radio frequency identification (RFID) for item management - Software system infrastructure - Part 5: Device interface

ISO/IEC 24791-5:2012 defines an interface within the Software System Infrastructure (SSI) that provides RFID system control components with low-level access to RFID interrogators for the purpose of optimizing RFID data access and control operations. This interface is designed to be modular with the ability to support multiple RFID air protocols. However, in ISO/IEC 24791-5:2012, the only RFID air protocol supported is Type C of ISO/IEC 18000-6.

This standard is also available from: BS


AAMI TIR45:2012 (AAMI TIR 45:2012)

Guidance on the use of agile practices in the development of medical device software

This Technical Information Report (TIR) provides perspectives on the application of AGILE during medical device software development.


AAMI TIR32:2004 (R2016)

Medical device software risk management

This AAMI technical information report provides information useful to performing effective software risk management, a significant part of the overall risk management process for medical devices containing software. It does this in the context of ANSI/AAMI/ISO 14971:2000, Medical devices - Application of risk management to medical devices, and in the context of ANSI/AAMI SW68:2001, Medical device software - Software life cycle processes.


IEC/TR 80002-1 Ed. 1.0 en:2009

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

"IEC/TR 80002-1:2009(E) provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to medical device software with reference to IEC 62304:2006, Medical device software - Software life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006. IEC/TR 80002-1:2009(E) is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use. The content of these two standards provides the foundation for this technical report. It should be noted that even though ISO 14971 and this technical report focus on medical devices, this technical report may be used to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. IEC/TR 80002-1:2009 is not intended to be used as the basis of regulatory inspection or certification assessment activities."

This standard is also available from: ANSI/AAMI  /  BS


IEC 62304 Ed. 1.0 b:2006

Medical device software - Software life cycle processes

Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.

This standard is also available from: ANSI/AAMI  /  BS


ISO 14971:2007

Medical devices - Application of risk management to medical devices

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

This standard is also available from: BS  /  DIN  /  SS  /  JIS


ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes


IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package

IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package

The IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package specifies the process of identifying, controling and monitoring risk and hazards associated with medical device software. This package can be to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system and those who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. It includes ISO 14971:2007 and IEC/TR 80002-1 Ed. 1.0 en:2009.


IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package

IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package

The IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package specifies the process of identifying, controling and monitoring risk and hazards associated with medical device software. It also defines the life cycle requirements for medical device software, set of processes, activities, and tasks establishing a common framework for medical device software life cycle processes. IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package is applicable to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. It includes ISO 14971:2007, IEC 62304 Ed. 1.1 en:2015 and IEC/TR 80002-1 Ed. 1.0 en:2009.


ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package

ISO 13485, IEC 62304 and ISO 14971 - Software, Quality and Risk Management of Medical Devices.

The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package provides the support to develop, implement, and maintain a medical devices quality and risk management system. It also includes the requirements for the software life cycle process for medical device software. The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package consolidates the IT, quality, and risk management medical devices necessities. It includes: IEC 62304 Ed. 1.1 en:2015 ISO 13485:2016 ISO 14971:2007


ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package

ANSI/AAMI/ISO 13485, ANSI/AAMI/IEC 62304 and ANSI/AAMI/ISO 14971 - Software, Quality and Risk Management of Medical Devices

The ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package provides the support to develop, implement, and maintain a medical devices quality and risk management system. It also includes the requirements for the software life cycle process for medical device software. The ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package consolidates the IT, quality, and risk management medical devices necessities. It includes: ANSI/AAMI/IEC 62304:2006 ANSI/AAMI/ISO 14971:2007 (R2010) ANSI/AAMI/ISO 13485:2016