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prEN ISO/IEEE 11073-10103 Viešoji apklausa

Komentavimo iki data 2025-06-17

Sveikatos informatika. Įtaisų funkcinis suderinamumas. 10103 dalis. Nomenklatūra. Implantuojamieji kardiologiniai įtaisai (ISO/IEEE FDIS 11073-10103:2025)

The base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices is extended in this standard. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system.

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prEN ISO 12052 Viešoji apklausa

Komentavimo iki data 2025-05-29

Sveikatos informatika. Skaitmeninių vaizdų sudarymas ir perdavimas medicinoje (DICOM), įskaitant darbo eigos ir duomenų valdymą (ISO 12052:2025)

ISO 12052:2017, within the field of health informatics, addresses the exchange of digital images and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information. ISO 12052:2017 facilitates interoperability of medical imaging equipment by specifying: - for network communications, a set of protocols to be followed by devices claiming conformance to this document; - the syntax and semantics of Commands and associated information which can be exchanged using these protocols; - for media communication, a set of media storage services to be followed by devices claiming conformance to this document, as well as a File Format and a medical directory structure to facilitate access to the images and related information stored on interchange media; - information that is to be supplied with an implementation for which conformance to this document is claimed. ISO 12052:2017 does not specify: - the implementation details of any features of the DICOM standard on a device claiming conformance; - the overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming conformance to this document; - a testing/validation procedure to assess an implementation's conformance to this document. ISO 12052:2017 pertains to the field of medical informatics. Within that field, it addresses the exchange of digital information between medical imaging equipment and other systems. Because such equipment may interoperate with other medical devices and information systems, the scope of this document needs to overlap with other areas of medical informatics. However, this document does not address the full breadth of this field. ISO 12052:2017 has been developed with an emphasis on diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. However, it is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments. ISO 12052:2017 facilitates interoperability of systems claiming conformance in a multi-vendor environment, but does not, by itself, guarantee interoperability.

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prEN ISO 22532 Archyvuotas

Komentavimo iki data 2025-05-20

Sveikatos informatika. Vaistų identifikavimas. Vaistų identifikavimo standartų pagrindinių terminų aiškinamasis žodynas (terminai ir apibrėžtys) (ISO/DIS 22532:2025)

This standard lists the terms and definitions to be used in the IDMP (Identification of medicinal products) standards and technical specifications, when terms and definitions as to be used in more than one of these standards.

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prEN ISO 16791 Archyvuotas

Komentavimo iki data 2025-05-13

Sveikatos informatika. Reikalavimai, keliami vaistų pakuočių identifikatorių tarptautiniam mašininio nuskaitymo kodavimui (ISO/DIS 16791:2025)

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).

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