Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO 12052:2017)

SO 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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ΚΩΔΙΚΟΣ ΠΡΟΪΟΝΤΟΣ: CYS EN ISO 12052:2017

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Medical device software - Software life-cycle processes

Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.

€119.00

Health informatics - Information security management in health using ISO/IEC 27002 (ISO 27799:2016)

ISO 27799:2016 gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of controls taking into consideration the organization's information security risk environment(s). It defines guidelines to support the interpretation and implementation in health informatics of ISO/IEC 27002 and is a companion to that International Standard. ISO 27799:2016 provides implementation guidance for the controls described in ISO/IEC 27002 and supplements them where necessary, so that they can be effectively used for managing health information security. By implementing ISO 27799:2016, healthcare organizations and other custodians of health information will be able to ensure a minimum requisite level of security that is appropriate to their organization's circumstances and that will maintain the confidentiality, integrity and availability of personal health information in their care. It applies to health information in all its aspects, whatever form the information takes (words and numbers, sound recordings, drawings, video, and medical images), whatever means are used to store it (printing or writing on paper or storage electronically), and whatever means are used to transmit it (by hand, through fax, over computer networks, or by post), as the information is always be appropriately protected.

€128.00

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement

This International Standard: — specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative medicinal product characteristics that require units of measurement (e.g. strength) in the human medicine domain; — establishes requirements for units in order to provide traceability to international metrological standards; — provides rules for the standardized and machine-readable documentation of quantitative composition and strength of medicinal products, specifically in the context of medicinal product identification; — defines the requirements for the representation of units of measurement in coded form; — provides structures and rules for mapping between different unit vocabularies and language translations to support the implementation of this International Standard, taking into account that existing systems, dictionaries and repositories use a variety of terms and codes for the representation of units. The scope of this International Standard is limited to the representation of units of measurement for data interchange between computer applications.

€97.00

Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)

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.

€84.00