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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
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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
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  • Standard
    144 pages
    English and French language
    sale 15% off
ISO
IEC 80601-2-77:2019(Main)
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.

  • Standard
    96 pages
    English and French language
    sale 15% off
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Frequently Asked Questions

ISO/TC 299/JWG 5 is a Technical Committee within the International Organization for Standardization (ISO). It is named "Joint ISO/TC 299 - IEC/SC 62A - IEC/SC 62D WG: Medical robot safety". This committee has published 4 standards.

ISO/TC 299/JWG 5 develops ISO standards in the area of Information technology. Currently, there are 4 published standards from this technical committee.

The International Organization for Standardization (ISO) is an independent, non-governmental international organization that develops and publishes international standards. Founded in 1947 and headquartered in Geneva, Switzerland, ISO brings together experts from 170+ member countries to share knowledge and develop voluntary, consensus-based standards that support innovation and provide solutions to global challenges.

A Technical Committee (TC) in ISO is a group of experts responsible for developing international standards in a specific technical area. TCs are composed of national member body delegates and work through consensus to create standards that meet global industry needs. Each TC may have subcommittees (SCs) and working groups (WGs) for specialized topics.