Standartų projektų sąrašas

prEN 18274 Viešoji apklausa

Komentavimo iki data 2025-11-25

Profesionalių DI etikos specialistų kompetencijos reikalavimai

This document provides a systematized framework for the competencies of AI ethicists, categorizing them into knowledge, skills and attitudes related to the specific activities and tasks of the role. It identifies requirements and recommendations necessary for individuals to effectively perform as AI ethicists. These competencies encompass a strong understanding of European values and fundamental rights, further enhancing the knowledge, skills and attitudes required for this profession. The document aims to foster a shared understanding of the essential concepts and principles inherent to the AI ethicist role. It illustrates a clear, uniform approach to the integral components of this profession. Moreover, the document outlines how the role of AI ethicists can be seamlessly integrated into a wide variety of organizations. These include, but are not limited to, commercial enterprises, governmental agencies and non-profit organizations.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

prEN ISO 11615 Viešoji apklausa

Komentavimo iki data 2025-11-25

Sveikatos informatika. Vaistų identifikavimas. Duomenų elementai ir struktūros, skirti unikaliam identifikavimui ir reglamentuotos informacijos apie vaistus mainams (ISO/DIS 11615:2025)

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

prEN ISO 21762 Viešoji apklausa

Komentavimo iki data 2025-11-25

Medicinos priemonės, kuriose naudojamos negyvybingos iš žmogaus gautos medžiagos. Rizikos valdymas (ISO/DIS 21762:2025)

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors. This document does not specify a quality management system for the control of all stages of production of medical devices.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

prEN ISO 15136-1 Viešoji apklausa

Komentavimo iki data 2025-11-30

Naftos ir gamtinių dujų pramonė. Sraigtinių siurblių sistemos naftai priverstinai pakelti. 1 dalis. Siurbliai (ISO/DIS 15136-1:2025)

ISO 15136-1:2009 provides requirements for the design, design verification and validation, manufacturing and data control, performance ratings, functional evaluation, repair, handling and storage of progressing cavity pumps for use in the petroleum and natural gas industry. ISO 15136-1:2009 is applicable to those products meeting the definition of progressing cavity pumps (PCP) included herein. Connections to the drive string and tubulars are not covered in ISO 15136-1:2009. ISO 15136-1:2009 establishes requirements for characterization and testing of stator elastomer material, design validation and functional evaluation and provides information for PCP elastomer selection and testing, installation, start-up and operation guidelines, equipment selection and application guidelines, functional specification form, used pump evaluation, drive string selection and use, repair and reconditioning procedures and auxiliary equipment. Equipment not covered by the requirements of ISO 15136-1:2009 includes bottom-drive systems except for the PCP components, drive-string components and auxiliary equipment such as tag bars, gas separators and torque anchors.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

prEN 304 223 V2.0.0 (2025-09) Viešoji apklausa

Komentavimo iki data 2025-11-24

Securing Artificial Intelligence (SAI); Baseline Cyber Security Requirements for AI Models and Systems

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

ISO/IEC DIS 28033-1 Viešoji apklausa

Komentavimo iki data 2025-11-24

Informacijos saugumas. Visiškai homomorfinis šifravimas. 1 dalis. Bendrieji dalykai

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

prEN 17161 Archyvuotas

Komentavimo iki data 2025-11-20

Tinkamumas visiems. Produktų, prekių ir paslaugų prieinamumas pagal tinkamumo visiems požiūrį.

This document specifies requirements and recommendations that can enable an organization to design, develop and provide products and services so that they can be accessed, understood and used by the widest range of users, including persons with disabilities. This document specifies requirements and recommendations that can enable an organization to widen their range of users by identifying diverse needs, characteristics, capabilities, and preferences, by directly or indirectly involving users, and by using knowledge about accessibility in its procedures and processes. This document specifies requirements that can enable an organization to meet applicable statutory and regulatory requirements as related to the accessibility of its products and services. The requirements and recommendations set out in this document are generic and are intended to be applicable to all relevant parts of all organisations, regardless of type, size or products and services provided. This document promotes accessibility following a Design for All approach in mainstream products and services and interoperability of these with assistive technologies.

Peržiūrėti metaduomenis

prEN IEC 60061-PR2025-2:2025 Archyvuotas