Informationsteknik, kontorsutrustning

This document establishes an Artificial Intelligence (AI) and Machine Learning (ML) framework for describing a generic AI system using ML technology. The framework describes the system components and their functions in the AI ecosystem. This document is applicable to all types and sizes of organizations, including public and private companies, government entities, and not-for-profit
organizations, that are implementing or using AI systems.

This document establishes terminology for AI and describes concepts in the field of AI.
This document can be used in the development of other standards and in support of communications among diverse, interested parties or stakeholders.
This document is applicable to all types of organizations (e.g. commercial enterprises, government agencies, not-for-profit organizations).

This document provides a systematized framework for the competencies of AI ethicists, categorizing them into knowledge, skills and attitudes related to the specific activities and tasks of the role. It identifies requirements and recommendations necessary for individuals to effectively perform as AI ethicists. These competencies encompass a strong understanding of European values and fundamental rights, further enhancing the knowledge, skills and attitudes required for this profession. The document aims to foster a shared understanding of the essential concepts and principles inherent to the AI ethicist role. It illustrates a clear, uniform approach to the integral components of this profession. Moreover, the document outlines how the role of AI ethicists can be seamlessly integrated into a wide variety of organizations. These include, but are not limited to, commercial enterprises, governmental agencies and non-profit organizations.

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

This document provides the terms and definitions commonly used in the cybersecurity requirements for products with digital elements family of standards.

This document specifies general cybersecurity principles and general risk management activities for all products with digital elements, hereafter also referred to as 'products'. This document covers every stage of the product lifecycle to ensure and maintain an appropriate level of cybersecurity based on the risks. This document also provides generic elements to support the development of coherent product-category-specific standards (vertical standards). This document: — establishes generic cybersecurity principles applicable to all stages of the product lifecycle; — specifies requirements for risk assessment and treatment of cybersecurity risks; — specifies requirements on activities that can be applied to ensure an appropriate level of cybersecurity at every phase of the product lifecycle; — provides elements and considerations for product category specific standards in order to facilitate a harmonized approach. This document does not provide vertical product category specific activities and elements.

Detta dokument beskriver processen för mottagande, kontroll, rengöring och desinfektion, paketering, märkning samt sterilisering av låneinstrument innan de ska användas. Dokumentet beskriver även en säkrad returprocess till den som äger ansvaret för låneinstrumentet.

In respect of pan European eCall (operating requirements defined in EN 16072), this document defines the high level application protocols, procedures and processes required to provide the eCall service via a packet switched wireless communications network using IMS (IP Multimedia Subsystem) and wireless access (such as LTE, NR and their successors). This document assumes support of eCall using IMS over packet switched networks by an IVS and a PSAP and further assumes that all PLMNs available to an IVS at the time an eCall or test eCall is initiated are packet switched networks. Support of eCall where eCall using IMS over packet switched networks is not supported by an IVS or PSAP is out of scope of this document. At some moment in time packet switched networks will be the only Public Land Mobile Networks (PLMN) available. However as long as GSM/UMTS PLMNs are available (Teleservice 12/TS12) ETSI TS 122 003 will remain operational. Both the use of such PLMNs and the logic behind choosing the appropriate network in a hybrid situation (where both packet-switched and circuit-switched networks are available) are out of scope of this document. NOTE 1 The objective of implementing the pan-European in-vehicle emergency call system (eCall) is to automate the notification of a traffic accident, wherever in Europe, with the same technical standards and the same quality of services objectives by using a PLMN (such as ETSI prime medium) which supports the European harmonized 112/E112 emergency number (TS12 ETSI TS 122 003 or IMS packet switched network) and to provide a means of manually triggering the notification of an emergency incident. NOTE 2 HLAP requirements for third party services supporting eCall can be found in EN 16102. This document makes reference to those provisions but does not duplicate them.

This document defines the key actors in the eCall chain of service provision using IMS over packet switched networks (such as LTE/4G) as: 1) In-vehicle system (3.20) (IVS)/vehicle, 2) Mobile network Operator (MNO), 3) Public safety answering point (3.27) (PSAP), and to provide conformance tests for actor groups 1) - 3). NOTE 1 Conformance tests are not appropriate nor required for vehicle occupants (3.36), although they are the recipient of the service. NOTE 2 Third party eCall systems (TPS eCall) are not within the scope of this deliverable. This is because the core TPS-eCall (3.32) standard (EN 16102) does not specify the communications link between the vehicle and the TPS service provider (3.29). NOTE 3 These conformance tests are based an the appropriate conformance tests from EN 16454 which was published before Internet Protocol multimedia Systems (IMS) packet switched networks were available. This deliverable therefore replicates the appropriate tests from EN 16454 (and acknowledge their source); adapt and revise Conformance Test Protocols (CTP) from EN 16454 to an IMS paradigm; or provide new additional tests that are required for the IMS paradigm. Some 14 112-eCall (Pan European eCall) tests provided in EN 16454 are specific to GSM/UMTS circuit switched communications and not appropriate for the IMS paradigm and are therefore excluded from this deliverable. This document therefore provides a suite of ALL conformance tests for IVS equipment, MNO's, and PSAPS, required to ensure and demonstrate compliance to CEN/TS 17184. NOTE 4 Because in the event of non-viability or non-existence of an IMS supporting network at any particular time/location, IMS-eCall systems revert to CS networked eCall systems eCall via GSM/UMTS, IVS and PSAPs need to support, and prove compliance to both IMS and CS switched networks. The Scope covers conformance testing (and approval) of new engineering developments, products and systems, and does not imply testing associated with individual installations in vehicles or locations.

1.1 In Scope The EN 9300-5xx series specifies the methods for long term archiving and retrieval of MBSE data represented as digital models. The characterization of models that are considered in scope of this document and the MBSE process use cases include: - product or system design requirements models; - functional architecture models; - logical architecture models (system structure, arrangement, connectivity, software allocations and controls, and part relationships); - numerically-based system analysis and simulation models, generally regulated 1D control loop models featuring system components and transport elements (tubing, piping, signalling, software); - verification and validation of requirements; - protocol dependent signal or communication networks; - multi-model linking and system parametric models; - system trade study models; - the solution architecture models and data that are needed to implement the system and generate system engineering data for downstream designs. 1.2 Out of Scope The EN 9300-5xx series does not address the original product model design process, or a specific configuration management process for the LOTAR archive. It does not address models depicting part specific technical data (physical materials or detail part standards). It is assumed that these archiving processes are within the scope of other parts of the EN 9300 series such as the 1xx series for CAD, the 2xx series for Product Data Management (PDM) data, or by applying existing alternative industry standards, or existing company business procedures. Typical models and capabilities considered out of scope of this document include: - physical spatial models or composite structures (as described by other LOTAR Parts); - Finite Element and CFD models (as described by other LOTAR Parts); - Product Data Management models (as described by other LOTAR Parts); - electrical circuit boards, or physical wiring parts or systems (described by other LOTAR Parts or standards); - the software development process and software models that are outside of the context of software parts, behaviours, or functions that represent software code within a model; - how to preserve property and access rights, or government acquisition-regulatory controls; - new standards, or major revisions to existing MBSE standards that were not available or applicable prior to the publication of this document.

This document specifies a concrete[1] implementable, conformance-testable coverage structure based on the abstract schema for coverages defined in the ISO 19123 schema for coverage geometry. This document defines a structure that is suitable for encoding in many encoding formats. [1] "concrete" is used here as a contrast to "abstract" in the sense described in the Introduction.

This document specifies the requirements and provides guidance for the definition, implementation, maintenance and improvement of a quality management system for organizations that provide AI systems. This document is intended to support the organization in meeting applicable regulatory requirements.