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Test correct weight support level

This protocol can be used to validate the weight support level for Weight Support Systems used in the healthcare domain, where the amount of weight support can be varied by a therapist according to the need for the therapy of a subject .

COVR WSU-LRE-1

Test correct weight support Level – using crane

This protocol can be used to validate the weight support level for Weight Support Systems used in the healthcare domain, where the amount of weight support can be varied by a therapist according to the need for the therapy of a subject.

COVR WSU-LRE-2

Test Limit Restraining Energy for Upper Limb Exoskeleton Type RACA Robots

This protocol is to be used to test the restraining energy that can be applied to a human subject during use of an exoskeleton used for upper limb support. This protocol is both aimed at exoskeletons used in the medical domain as well as at exoskeletons used in the industrial, logistic or agricultural domain.

COVR EXO-LRE-2

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.

IEC 80601-2-77:2019

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

EC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.IEC 80601-2-78:2019 does not apply to• external limb prosthetic devices (use ISO 22523),• electric wheelchairs (use ISO 7176 (all parts)),

IEC 80601-2-78:2019

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