International Standard
IEC 80601-2-78:2019
Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Reference number
IEC 80601-2-78:2019
Edition 1
2019-07
International Standard
Read sample
IEC 80601-2-78:2019
68474
Published (Edition 1, 2019)
This standard has 1 amendment.

IEC 80601-2-78:2019

IEC 80601-2-78:2019
68474
Language
Format
CHF 345
Convert Swiss francs (CHF) to your currency

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).

General information

  •  : Published
     : 2019-07
    : International Standard published [60.60]
  •  : 1
     : 144
  • ISO/TC 299
    11.040.01 
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Edition 2024

IEC 80601-2-78:2019/Amd 1:2024
83341
Language
Format
CHF 115
Convert Swiss francs (CHF) to your currency

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