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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

Robots and robotic devices — Safety requirements for industrial robots — Part 1: Robots

ISO 10218-1:2011 specifies requirements and guidelines for the inherent safe design, protective measures and information for use of industrial robots. It describes basic hazards associated with robots and provides requirements to eliminate, or adequately reduce, the risks associated with these hazards.ISO 10218-1:2011 does not address the robot as a complete machine. Noise emission is generally not considered a significant hazard of the robot alone, and consequently noise is excluded from the scope of ISO 10218-1:2011.ISO 10218-1:2011 does not apply to non‑industrial robots, although the safety principles established in ISO 10218 can be utilized for these other robots.

ISO 10218-1:2011

Robotics — Performance criteria and related test methods for service robots — Part 3: Manipulation

This document describes methods of specifying and evaluating the manipulation performance of service robots, notably:— grasp size. — grasp strength. — grasp slip resistance. — opening a hinged door; and— opening a sliding door.There are other grasping characteristics and use cases for manipulation of service robots. It is expected that these will be included in a future revision.This document deals with the indoor environment only. However, the depicted tests can also be applicable for robots operating in outdoor environments.This document is not applicable for the verification or validation of safety requirements.

ISO 18646-3:2021

Robotics — Performance criteria and related test methods for service robots — Part 4: Lower-back support robots

his document describes methods of specifying and evaluating the performance of lower-back support robots.This document applies regardless of the purpose and application of lower-back support robots and the driving methods (e.g. electric, hydraulic and pneumatic). This document does not apply to medical robots, although the test methods specified in this document can be utilized for medical robots.This document is not intended for the verification or validation of safety requirements.

ISO 18646-4:2021

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

Robotics — Application services provided by service robots — Safety management systems requirements

This document specifies the requirements of safety management systems for application services provided by service robots (application service safety management system (hereafter AsSMS)) that an application service provider can use for the safety of its users and its third parties when it provides application service in unstructured human spaces with trained and untrained persons. (e.g., giving directions for visitors in airport or shopping mall, carrying goods to patients in hospital, delivering food to customers in restaurant.)This document is applicable to any organization that wishes toa) improve safety performance of application services provided by service robots,b) establish, implement, maintain and improve safety management systems for application services provided by service robots,c) assure itself of conformity with its stated application service safety policy, andd) demonstrate conformity with this document.The requirements of this document can be conformed to by integrating safety management systems for application services provided by service robots into, or making it compatible with, other management system or processes within the organization.The requirements of this document can be conformed to by multiple organizations without omission depending on what shall be done as an organization and a safety management.Although intended for application services provided by service robots, this standard can also be applied for services using robots other than service robots.This document is not intended to be used as a product safety standard.NOTE The safety management systems for application services provided by service robots established in accordance with the requirements of this document may not apply directly when service robots to be used, robot systems, contents of service, places of operation, users or so differ.

ISO/DIS 31101