Standard

SFS-EN IEC 80601-2-78:2020

Apr 2020 Published

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Language English

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Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation Published SFS-EN IEC 80601-2-78:2020/A1:2024 Amendment from Publication date: Oct 2024 Pages: 21 Language: English Services: Read online, Printed and bound, Read online + Copy/paste, Read online + Print/Download

Abstract

IEC 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)), • diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and • personal care ROBOTS (use ISO 13482).

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Standard from SFS-sähkö
Published: 17 April 2020
Edition: 1
Document type: IS
Pages
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Publisher SFS
Distributor SFS-sähkö
Technical Committee CLC/TC 62

SFS-EN IEC 80601-2-78:2020

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SFS-EN IEC 80601-2-78:2020/A1:2024

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