CEN

The present Technical Report provides guidance on the selection of standards and options for the signature/seal creation and other related devices (area 2) as identified in the framework for standardization of signatures: overview ETSI/TR 119 000 [16]. The present Technical Report describes the Business Scoping Parameters relevant to this area (see Clause 5) and how the relevant standards and options for this area can be identified given the Business Scoping Parameters (Clause 6). The target audience of this document includes: - business managers who potentially require support from electronic signatures/seals in their business and will find here an explanation of how electronic signatures/seals standards can be used to meet their business needs; - application architects who will find here material that will guide them throughout the process of designing a system that fully and properly satisfies all the business and legal/regulatory requirements specific to electronic signatures/seals, and will gain a better understanding on how to select the appropriate standards to be implemented and/or used; - developers of the systems who will find in this document an understanding of the reasons that lead the systems to be designed as they were, as well as a proper knowledge of the standards that exist in the field and that they need to know in detail for a proper development.

This Technical Report aims to help citizens to understand the relevance of using electronic signature within their day-to-day lives. It also explains the legal and the technical backgrounds of electronic signatures. This document gives guidance on the use of electronic signatures and addresses typical practical questions the citizen may have on how to proceed to electronically sign, where to find the suitable applications and material.

Semantic data model for electronic invoices, with profiles for the two major EU invoice specifications (see UBL and CII below).

This European Standard is applicable to all construction products and services related to buildings. It specifies and describes the communication format for the information defined in EN 15804:2019 for business-to-business communication to ensure a common understanding through consistent communication of information. NOTE This European Standard does not deal with business to consumer communication and is not intended for that purpose. Business to consumer communication format is planned to be the subject of a future document.

This document supports the data quality assessment and selection of data for product-level Environmental Product Declarations (EPD) according to the core product category rules of EN 15804 and for the environmental performance assessment of buildings according to prEN 15978-1 in a consistent way. It can also be used to assess and select data for the environmental assessment of civil engineering works. It defines data quality requirements with respect to temporal, technological and geographic representativeness for the data used to calculate the LCA based indicator results of the EPD and for construction works when applying EPD, life cycle inventory data or other LCA based information and generates a hierarchy to support the selection of the most appropriate data with regard to data quality. It also addresses the reporting of data quality at product and building level.

The scope of this standard is a service-oriented medical device architecture and communication protocol specification for distributed system of Point-of-Care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices. It identifies the functional components, their communication relationships as well as the binding of the components and communication relationships to protocol specifications.

This Technical Specification (TS) provides implementation guidance to support the use of the International Patient Summary dataset in a European context. The focus of this technical specification takes into consideration European specific jurisdictional requirements, needs and contexts that Europe requires to be satisfied for effective implementation. It addresses both functional and non-functional requirements for the dataset’s interchange. As part of the usability of the International Patient Summary, European perspectives, directives and regulations contextualise and add value to generic reference implementations for use by Member States. The TS applies the refined European Interoperability Framework (ReEIF), which describes legal, organisational, semantic and technological considerations for interoperability. These considerations highlight the eHealth Network’s (eHN) guidance for cross-border care and underpin the care process. The TS formalises principles to support the safe and legitimate use of patient summary data and afford protection for efficient cross-border data interchange within scenarios for unscheduled care. This Technical Specification gives selection criteria and provides examples of various transport formats and terminologies shown to be suitable for interchanging the International Patient Summary dataset. Compliance, deployment & migration Guidance are also included. The TS distinguishes between cross-border only requirements for interchanging the dataset and those that are generally applicable within national borders.

The scope of this project is to define a general object-oriented information model that may be used to structure information and identify services used in point-of-care (POC) medical device communications. The scope is primarily focused on acute care medical devices and the communication of patient vital signs information.

This document specifies the common conventions required for the cart-to-host as well as cart-to-cart interchange of specific patient data (demographic, recording, ...), ECG signal data, ECG measurement and ECG interpretation results. This document specifies the content and structure of the information which is to be interchanged between digital ECG carts and computer ECG management systems, as well as other computer systems where ECG data can be stored

This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to develop a knowledge base, the topics to be considered by the developers of a knowledge base, and it gives guidance on how to do this. This document gives guidelines for the development of a knowledge base: — with rules to enhance decisions and actions in drug-related problems that cohere with the intended drug use; — which can be used by all kinds of healthcare professionals, such as those who prescribe, dispense, administer or monitor medicines; — which can be used in every care setting, including chronic and acute care, primary and specialized care; — which is a repository of evidence/practice bases rules, assessed by experts; — which is meant to be used in conjunction with a medicinal product dictionary; — whose knowledge is structured in rules and therefore to be used in the type of rule-based CDSS. This document does not: — describe the exact content of a knowledge base i.e. the outcome of the process of developing rules. — provide the requirements for a clinical decision support system, the software that uses the knowledge base combined with the patient's data, and presents the outcome of the rules to the healthcare professional. These requirements are described in ISO/DTS 22703[1]. — give the requirements for non-medication knowledge bases. Some aspects of the requirements in this document are general in nature and applicable to other kinds of knowledge bases, but this document does not address all of the requirements of non-medication knowledge bases. [1] Under preparation. Stage at the time of publication: ISO/DTS 22703.

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID)