ISO

This document defines the core data set for a patient summary document that supports continuity of care for a person and coordination of their healthcare. It is specifically aimed at supporting the use case’ scenario for ‘unplanned, cross border care’ and is intended to be an international patient summary (IPS). Whilst the data set is minimal and non-exhaustive, it provides a robust, well-defined core set of data items. The tight focus on this use case also enables the IPS to be used in planned care. This means that both unplanned and planned care can be supported by this data set within local and national contexts, thereby increasing its utility and value.

It uses the European Guideline from the eHN as the initial source for the patient summary requirements, then takes into consideration other international patient summary projects to provide an interoperable data set specification that has global application.

This document provides an abstract definition of a Patient Summary from which derived models are implementable. Due to its nature therefore, readers should be aware that the compliance with this document does not imply automatic technical interoperability; this result, enabled by this document, can be reached with the conformity to standards indicated in the associated technical specification and implementation guides.

This document specifies engineering requirements for cybersecurity risk management regarding concept, product development, production, operation, maintenance and decommissioning of electrical and electronic (E/E) systems in road vehicles, including their components and interfaces.

A framework is defined that includes requirements for cybersecurity processes and a common language for communicating and managing cybersecurity risk.

This document is applicable to series production road vehicle E/E systems, including their components and interfaces, whose development or modification began after the publication of this document.

This document does not prescribe specific technology or solutions related to cybersecurity.

This document is intended to be applied to safety-related systems that include one or more electrical and/or electronic (E/E) systems and that are installed in series production road vehicles, excluding mopeds. This document does not address unique E/E systems in special vehicles such as E/E systems designed for drivers with disabilities.

NOTE Other dedicated application-specific safety standards exist and can complement the ISO 26262 series of standards or vice versa.

Systems and their components released for production, or systems and their components already under development prior to the publication date of this document, are exempted from the scope of this edition. This document addresses alterations to existing systems and their components released for production prior to the publication of this document by tailoring the safety lifecycle depending on the alteration. This document addresses integration of existing systems not developed according to this document and systems developed according to this document by tailoring the safety lifecycle.

This document addresses possible hazards caused by malfunctioning behaviour of safety-related E/E systems, including interaction of these systems. It does not address hazards related to electric shock, fire, smoke, heat, radiation, toxicity, flammability, reactivity, corrosion, release of energy and similar hazards, unless directly caused by malfunctioning behaviour of safety-related E/E systems.

This document describes a framework for functional safety to assist the development of safety-related E/E systems. This framework is intended to be used to integrate functional safety activities into a company-specific development framework. Some requirements have a clear technical focus to implement functional safety into a product; others address the development process and can therefore be seen as process requirements in order to demonstrate the capability of an organization with respect to functional safety.

This document defines the vocabulary of terms used in the ISO 26262 series of standards.