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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

Designing for Safety and Lean Manufacturing: A guide on integrating safety and lean manufacturing principles in the use of machinery

This document provides guidance on the practical application of safety and lean manufacturing principles to machinery and manufacturing systems for improving performance, safety and quality by reducing injury and waste. The guidelines in this technical report assist machine tool users to minimize waste and risk associated with machinery and manufacturing systems, including individual and integrated machine tools and auxiliary components.
B11.TR7—2007

Enterprise modelling and architecture — Constructs for enterprise modelling

This document identifies and specifies constructs necessary for users that model enterprises in conformance with ISO 19439.This document focuses on, but is not restricted to, engineering and the integration of manufacturing and related services in the enterprise. The constructs enable the description of structure and functioning of an enterprise for use in configuring or implementing in different application domains. This document specifies an implementation framework in Clause 6 to map model constructs into such domains.
ISO 19440:2020

Safety of machinery — Prevention of unexpected start-up

ISO 14118:2017 specifies requirements for designed-in means aimed at preventing unexpected machine start-up (see 3.2) to allow safe human interventions in danger zones (see Annex A).ISO 14118:2017 applies to unexpected start-up from all types of energy source, i.e.:- power supply, e.g. electrical, hydraulic, pneumatic. - stored energy due to, e.g. gravity, compressed springs. - external influences, e.g. from wind.ISO 14118:2017 does not specify performance levels or safety integrity levels for safety-related parts of control systems. While available means to prevent unexpected start-up are identified, this document does not specify the means for the prevention of unexpected machine start-up for specific machines.NOTE A type-C standard can define the required means for the prevention of harm arising from unexpected start-up. Otherwise, the requirements for a specific machine need to be determined by risk assessment outside the scope of this document.
ISO 14118:2017