Informationsteknik, kontorsutrustning

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 provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

This document defines cyber security requirements for products with digital elements belonging to product category “application on the Smart Cards, Secure Elements, and similar devices” (hereinafter called “Product”). It extends the prEN 50764:2026, which defines the cyber security requirements for the platform underneath the application.

All products with digital elements having the form of a Smart Card or any similar device, where application is not installed on a platform defined by prEN 50764:2026 are excluded from the scope of this document.

More details about the product context in scope is given with Clause 4

ISO/IEC 25063:2014 describes the Common Industry Format (CIF) for context of use descriptions and specifies the contents of both high-level and detailed descriptions of the context of use for an existing, intended, implemented or deployed system. A context-of-use description includes information about the users and other stakeholder groups, the characteristics of each user group, the goals of the users, the tasks of the users, and the environment(s) in which the system is used. The context of use description is applicable to software and hardware systems, products or services (excluding generic products, such as a display screen or keyboard). It is important to gather and analyse information on the current context in order to understand and then describe the context that will apply in the future system. The context of use description provides a collection of data relevant for analysis, specification, design and evaluation of an interactive system from the perspective of the various user groups and other stakeholders.

This document gives guidelines for: a process on privacy impact assessments, and a structure and content of a PIA report. It is applicable to all types and sizes of organizations, including public companies, private companies, government entities and not-for-profit organizations. This document is relevant to those involved in designing or implementing projects, including the parties operating data processing systems and services that process PII.

The scope of this standard is to define a nomenclature for communication of information from point-of care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object oriented information model that is for medical device communications. This amendment extends IEEE Std 11073-10101-2019 to include additional terms primarily related to infusion pumps, ventilators, dialysis and other key medical devices as well as event and alert identifiers for devices and systems used in acute care

This document provides methodology for the use of statistical methods to assess robustness properties of neural networks. The document focuses on how to select, apply and manage statistical methods to assess robustness properties.

The standard specifies a data model in UML and a derived XML schema (XSD) for defining the Level of Information Need in software applications based on concepts and principles given in Part 1, and guidance given in Part 2, in compliance with the principles and data exchange standards of data templates (ISO 23387). The standard defines the exchange format schema in XSD according to the UML schema and it gives guidelines for the usage and application of the schema. In addition, the integration with Linked Data principles and paradigms will be demonstrated.

This document gives guidelines for: a process on privacy impact assessments, and a structure and content of a PIA report. It is applicable to all types and sizes of organizations, including public companies, private companies, government entities and not-for-profit organizations. This document is relevant to those involved in designing or implementing projects, including the parties operating data processing systems and services that process PII.