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ISO 25237:2017, 3.42.Health informatics: Pseudonymization

ISO 25237:2017 contains principles and requirements for privacy protection using pseudonymization services for the protection of personal health information. This document is applicable to organizations who wish to undertake pseudonymization processes for themselves or to organizations who make a claim of trustworthiness for operations engaged in pseudonymization services. It (a) defines one basic concept for pseudonymization, (b) defines one basic methodology for pseudonymization services including organizational, as well as technical aspects, (c) specifies a policy framework and minimal requirements for controlled re-identification,(d) gives an overview of different use cases for pseudonymization that can be both reversible and irreversible,(e) gives a guide to risk assessment for re-identification, (f) provides an example of a system that uses de-identification, (g) provides informative requirements to an interoperability to pseudonymization services, and (h) specifies a policy framework and minimal requirements for trustworthy practices for the operations of a pseudonymization service

ISO 25237:2017

ISO/TR 19669:2017, 3.11. Health informatics: Re-usable component strategy for use case development

ISO/TR 19669:2017 specifies a use case development methodology, facilitated by a dynamic catalogue of re-usable components. Use cases are a basic tool in describing requirements for health and healthcare settings, service provision, information technology and software products. Use case development often follows a uniform template with components such as actors, roles, scenarios, event steps, actions, data objects/ elements and requirements statements. ISO/TR 19669:2017 includes a basic use case template and the methods of component identification, capture, cataloguing and re-use. This document also includes guidance for software designed to implement the methodology in the form of a use case authoring too.

ISO/TR 19669:2017

Manipulating industrial robots — Performance criteria and related test methods

This International Standard describes methods of specifying and testing the following Performance characteristics of manipulating industrial robots: pose accuracy and pose repeatability; multi-directional pose accuracy Variation; distance accuracy and distance repeatability; Position stabilization time; Position overshoot; drift of pose characteristics; exchangeability; path accuracy and path repeatability; path accuracy on reorientation cornering deviations; path velocity characteristics; minimum posing time; static compliance; weaving deviations.

ISO 9283:1998

Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy

IEC TR 60601-4-1:2017(E) is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA). This document provides a definition of DOA of MEE or MES and a medical robot, and also provides guidance on: - methodologies to perform the risk management process and usability engineering for an MEE or MES with a DOA; - considerations of basic safety and essential performance for an MEE and MES with a DOA; and - identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and - distinguishing between medical robots, and other MEE and MES. Unless specified otherwise, this document considers MEE and MES together. The manufacturer of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its intended use and does not have unacceptable risk throughout its life-cycle. This document provides guidance to help the manufacturer in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers. There are no prerequisites to this document.

IEC/TR 60601-4-1:2017

Robotics — Application of ISO 13482 — Part 1: Safety-related test methods

This document describes methods that can be used to test personal care robots in terms of safety requirements defined in ISO 13482. The target robots of this document are identical to those of ISO 13482.The manufacturer determines the required tests and appropriate testing parameters based on a risk assessment of the robot's design and usage. This risk assessment can determine that tests and test parameters other than those contained in this document are acceptable.Not all test methods are applicable to all robot types. Test methods labelled "universal" are applicable to all personal care robots. For other tests, the heading states for which robot types the test can be applied (e.g. "for wearable robot" or "for mobile robot").Some test methods can be replaced by using other applicable standards, even if they are not listed in this document.

ISO/TR 23482-1:2020

Robotics — Application of ISO 13482 — Part 2: Application guidelines

This document provides guidance on the use of ISO 13482 and is intended to facilitate the design of personal care robots in conformity with ISO 13482. Additional guidance is provided for users with limited experience of risk assessment and risk reduction. This document provides clarification and guidance on new terms and safety requirements introduced to allow close human-robot interaction and human-robot contact in personal care robot applications, including mobile servant robots, physical assistant robots and person carrier robots. This document considers the application of ISO 13482 to all service robots and includes related examples.

ISO/TR 23482-2:2019

Robotics — Modularity for service robots — Part 201: Common information model for modules

This standard complies with the ISO 22166 family of standards providing requirements and guidelines on specifications on modularity for service robots. This Part 201 presents requirements and guidelines for common information models for modules of service robots.

ISO/ CD 22166-201