IT-tillämpningar

ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017.

This document specifies business requirements for processes intended to preserve digital data. NOTE Data are stored and maintained for the purpose of retrievability and usability during the required archiving period. In addition, for the purpose of some business requirements, data are authentically preserved and accessed. This document is intended to allow for different implementations based on a company’s specific business environment. This document is not intended to incorporate company specific requirements and does not dictate specific organizational structures within a company. This document does not specify a design or an implementation of an archive system. Actual implementations can distribute responsibilities or break out functionality differently. This document assumes that all requirements for configuration management of the product data are in place and therefore are not specifically described in this document.

 ISO 14819-1 describes the ALERT-C protocol concept and message structure used to achieve densely coded messages to be carried in the RDS-TMC feature. This document specifies the ‘Events List’ to be used in coding those messages.

The present document is composed of the following data packages:

— journey and Interchange;

— vehicle Journey Assignment;

— journey Times;

— block and Vehicle Service;

— dated Journey;

— explicit Frame.

This document itself is composed of the following parts:

— main document representing the data model for the concepts shared by the different domains covered by Transmodel (normative);

— Annex A containing the data dictionary and attribute tables, i.e. the list of all the concepts presented in the main document together with their definitions (normative);

— Annex B presenting the model evolution (informative);

— Annex C, providing details of the significant technical changes between this document and EN 12896 1:2015 (informative)

This document incorporates the following main data packages:

— Network Description;

— Fixed Object;

— Tactical Planning Components;

— Explicit Frame.

It is composed of the following parts:

— main document representing the data model for the concepts shared by the different domains covered by Transmodel (normative);

— Annex A containing the data dictionary and attribute tables, i.e. the list of all the concepts presented in the main document together with their definitions (normative);

— Annex B presenting the model evolution (informative).

— Annex C, providing details of the significant technical changes between this document and EN 12896-2:2016 (informative). 

This document incorporates the following main data packages:

— Dated Production Components;

— Call;

— Dated Call;

— Production Plan;

— Detecting & Monitoring;

— Situation;

— Messaging;

— Control Action;

— Operational Event & Incident;

— Facility Monitoring & Availability;

— Occupancy.

It is composed of the following parts:

— main document representing the data model for the concepts shared by the different domains covered by Transmodel (normative);

— Annex A containing the data dictionary and attribute tables, i.e. the list of all the concepts presented in the main document together with their definitions (normative);

— Annex B presenting the model evolution (informative);

— Annex C detailing the mapping to DATEX-II and SIRI (informative).

— Annex D, providing details of the significant technical changes between this document and EN 12896-4:2019 (informative).

This document entitled “Public transport – Reference data model – Part 5: Fare Management” is 

composed of the following data packages: 

— Fare Structure; 

— Access Right Assignment; 

— Fare Pricing; 

— Sales Description; 

— Sales Transaction; 

— Fare Roles; 

— Validation and Control; 

— Explicit Frames for Fares. 

This document itself is composed of the following parts: 

— Main document representing the data model for the concepts shared by the different domains 

covered by Transmodel (normative); 

— Annex A, containing the data dictionary and attribute tables, i.e., the list of all the concepts presented 

in the main document together with the definitions (normative); 

— Annex B, presenting the model evolution (informative). 

— Annex C, providing details of the significant technical changes between this document and EN 12896

5:2019 (informative)

The document incorporates the following main data packages: 

— Trip Description; 

— Passenger Information Queries. 

It is composed of the following parts: 

— main document representing the data model for the concepts shared by the different fare domains 

covered by Transmodel (normative); 

— Annex A, containing the data dictionary and attribute tables, i.e. the list of all the concepts presented 

in the main document together with the definitions (normative); 

— Annex B presenting the model evolution (informative). 

— Annex C, providing details of the significant technical changes between this document and 

EN 12896-6:2019 (informative).

This document is composed of the following data packages: 

— Driver; 

— Driver Schedule; 

— Rostering; 

— Personnel Disposition; 

— Driver Control Action. 

This document itself is composed of the following parts: 

— main document representing the data model for the concepts shared by the different domains 

covered by Transmodel (normative); 

— Annex A containing the data dictionary and attribute tables, i.e., the list of all the concepts presented 

in the main document together with their definitions (normative); 

— Annex B presenting the model evolution (informative). 

— Annex C, providing details of the significant technical changes between this document and EN 12896

7:2019 (informative)

This document describes common capabilities, requirements and a supporting information model for logging of events in AI systems. This document is designed to be used with a risk management system.

This document provides guidance on human control and monitoring of AI systems, which is referred to as human oversight. This document extends ISO/IEC TS 8200. This document is applicable to all types of organizations. This document is applicable throughout the AI system life cycle.

This document incorporates data structures used by all other data domains of Transmodel. It is composed of the following data packages:

versions and validity; 

responsibility; 

generic framework; 

reusable components; 

explicit frames referring to generic data. 

The data structures represented in this part are either generic patterns that can be explicitly reused in 

other domains (e.g., a generic model for version frames, a generic grouping mechanism, etc.) or are 

referenced by different other parts (e.g., service calendar model). 

This document itself is composed of the following parts: 

main document representing the data model for the concepts shared by the different domains covered by Transmodel (normative);

Annex A containing the data dictionary and attribute tables, i.e., the list of all the concepts 

present in the main document, together with their definitions (normative);  

Annex B, indicating the data model evolutions (informative), 

Annex C, presenting the Transmodel development history (informative), 

Annex D, describing all conventions, methodology and notations for conceptual modelling (informative), 

Annex E, providing a clear overview to help readers understand the core principles, structure, and purpose of Transmodel (informative), 

Annex F, providing information on the Functional domains and Modes of operation (informative). 

Annex G, providing details of the significant technical changes between this document and EN 12896-1:2015 (informative). 

1.1 In scope This document defines a Recommended Practice for Product Structure validation. The objective is to validate the product structure of data ingested, extracted or re-used by the archive. This document defines a method to uniquely identify each node in the product structure and to uniquely define the structure of each assembly node. 1.2 Out of scope This document will not provide validation properties for documents; CAD or other.

This document specifies the syntax and semantics of data objects in the field of electronic fee collection (EFC). The definitions of data types and assignment of semantics are provided in accordance with the abstract syntax notation one (ASN.1) technique, as specified in ISO/IEC 8824-1. This document defines:

—    ASN.1 (data) types within the field of EFC;

—    ASN.1 (data) types of a more general use that are used more specifically in standards related to EFC.

This document does not seek to define ASN.1 (data) types that are primarily related to other fields that operate in conjunction with EFC, such as cooperative intelligent transport systems (C-ITS), the financial sector, etc.

This document specifies the test procedures of electronic fee collection (EFC) roadside equipment (RSE) and on-board equipment (OBE) with regard to the conformance to standards and requirements for type approval and acceptance testing which is within the realm of EFC application specifically. The scope of this document is restricted to systems operating within the radio emission, electromagnetic compatibility (EMC) regulations, traffic, and other regulations of the countries in which they are operated. This document identifies a set of suitable parameters and provides test procedures to enable the proof of a complete EFC system, as well as components of an EFC system, e.g. OBE, related to the defined requirements of an application. The defined parameter and tests are assigned to the following groups of parameters: — functionality; — quality; — referenced pre-tests. An overview of the tests and parameters provided by this document is given in 5.1 and 5.2. This document describes procedures, methods and tools, and a test plan which shows the relation between all tests and the sequence of these tests. It lists all tests that are required to measure the performance of EFC equipment. It describes which EFC equipment is covered by the test procedures; the values of the parameters to be tested are not included. It also describes how the tests are to be performed and which tools and prerequisites are necessary before this series of tests can be undertaken. It is assumed that the security of the system is inherent in the communications and EFC functionality tests, therefore they are not addressed here. All tests in this document provide instructions to evaluate the test results. This document defines only the tests and test procedures, not the benchmark figures that these are to be measured against. The test procedures defined in this document can be used as input, e.g. by scheme owners, for prototype testing, type approvals, tests of installations and periodic inspections. Related to a conceptual model of an EFC system, this document relates only to the equipment of the user and the service provider. Any other entities are outside the scope of document. EFC systems for dedicated short-range communication (DSRC) consist, in principle, of a group of technical components, which in combination fulfil the functions required for the collection of fees by electronic automatic means. These components comprise all, or most, of the following: — OBE within a vehicle; — OBE containing the communications and computing sub-functions; — optional integrated circuit card which may carry electronic money, service rights, and other secured information; — communication between OBE and RSE based on DSRC; — equipment for the fee collection at the RSE containing the communications and computing sub-functions; — equipment for the enforcement at the roadside; — central equipment for the administration and operation of the system. The scope of this document relates solely to OBE and RSE and the DSRC interface between OBE and RSE including its functions to perform the fee collection. All the equipment used for enforcement (e.g. detection, classification, localization, and registration) and central equipment are outside the scope of this document.

This document defines the architecture of electronic fee collection (EFC) system environments, in which a customer with one contract can use a vehicle in a variety of toll domains with a different toll charger (TC) for each domain.

EFC systems conforming to this document can be used for various purposes including road (network) tolling, area tolling, collecting fees for the usage of bridges, tunnels, ferries, for access or for parking. From a technical point of view the considered toll systems can identify vehicles subject to tolling by means of electronic OBE in a vehicle or by other means that are image-based (e.g. automatic number plate recognition, ANPR).

From a process point of view the architectural description focuses on toll determination, toll charging, 

provision of toll service to the user, and the associated enforcement measures. The actual collection of the toll, i.e. collecting payments, is outside of the scope of this document.

The architecture in this document is defined with no more details than required for an overall overview, a common language, an identification of the need for and interactions among other standards, and the drafting of these standards.

This document as a whole provides:

— the enterprise view on the architecture, which is concerned with the purpose, scope and policies 

governing the activities of the specified system within the organization of which it is a part;

— the terms and definitions specific to this standard, in addition to those provided in ISO/FDIS 17573-2;

— a decomposition of the EFC systems environment into its main enterprise objects;

— the roles and responsibilities of the main actors. This document does not impose that all roles perform all indicated responsibilities. It should also be clear that the responsibilities of a role can be shared between two or more actors. Mandating the performance of certain responsibilities is the task of standards derived from this architecture;

— identification of the provided services by means of action diagrams that underline the needed 

standardized exchanges;

— identification of the interoperability interfaces for EFC systems, in specialized standards.