iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ISO

ISO/TC 299/JWG 5 - Joint ISO/TC 299 - IEC/SC 62A - IEC/SC 62D WG: Medical robot safety

GT mixte ISO/TC 299 - IEC/SC 62A - IEC/SC 62D: Sécurité pour la technologie robotique

General Information

Status
Active
Work Field
Information technology
Parent
ISO/TC 299 - Robotics
Standardization Organization
ICS
Directive
Mandate
50
ISO
IEC 80601-2-78:2019/Amd 1:2024(Amendment)
Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation — Amendment 1
  • Draft
    12 pages
    English language
    sale 15% off
ISO
IEC 80601-2-77:2019/Amd 1:2023(Amendment)
Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment — Amendment 1
  • Standard
    12 pages
    English and French language
    sale 15% off
  • Draft
    8 pages
    English language
    sale 15% off
ISO
IEC 80601-2-78:2019(Main)
Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

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).

  • Standard
    160 pages
    English and French language
    sale 15% off
50