Information technology — Service management — Part 10: Overview and key concepts
This document describes the core concepts of ISO/IEC 20000 (all parts), identifying how the different parts support ISO/IEC 20000‑1:2018 as well as the relationships between ISO/IEC 20000-1 and other International Standards and Technical Reports. This document also includes the terminology used in all parts of ISO/IEC 20000, so that organizations and individuals can interpret the concepts…
Clinical investigation of medical devices for human subjects — Good clinical practice
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the…
Security and resilience — Authenticity, integrity and trust for products and documents — Framework f...
This document provides an approach that support stakeholders in a supply chain to accomplish a chain of trust regarding properties of identifiable material goods along a supply chain. This document gives guidance on the identification of trust domains and their corresponding trustworthiness attributes, and the measures to achieve the targeted trustworthiness attributes.
As a supply chain…
Investigation clinique des dispositifs médicaux pour sujets humains — Bonne pratique clinique
Le présent document traite des bonnes pratiques cliniques pour la conception, la conduite, l'enregistrement et l'établissement des rapports relatifs aux investigations cliniques menées sur des sujets humains en vue d'évaluer la performance clinique, l'efficacité ou la sécurité des dispositifs médicaux.
Dans le cadre des investigations cliniques après mise sur le marché, les…
Automation systems and integration — Equipment behaviour catalogues for virtual production system — ...
This document specifies interfaces of equipment behaviour catalogues (EBCs) to production system design and operation thus providing technical and contextual information for integration.
