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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 16-232
Standard
IEC  80601-2-78 Edition 1.0 2019-07
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Scope/Abstract
This part of IEC 80601 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.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
NOTE See also 4.2 of the general standard.

This particular standard 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).
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

NOTE: The definitions related to rehabilitation, assessment, compensation, and alleviation in this document do not represent typical FDA indications or language related to these device types.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.1925 System, Isokinetic Testing And Evaluation Class 2 IKK
§890.3475 Sling, Arm, Overhead Supported Class 1 ILE
§890.3475 Stocking, Elastic Class 1 ILG
§890.3475 Splint, Hand, And Components Class 1 ILH
§890.3475 Support, Arm Class 1 IOY
§890.3475 Orthosis, Limb Brace Class 1 IQI
§890.3475 Cage, Knee Class 1 ITM
§890.3475 Joint, Knee, External Brace Class 1 ITQ
§890.3475 Joint, Hip, External Brace Class 1 ITS
§890.3475 Joint, Ankle, External Brace Class 1 ITW
§890.3475 Orthosis, Corrective Shoe Class 1 KNP
§890.3475 Orthosis, Foot Drop Class 1 OHI
§890.3480 Powered Exoskeleton Class 2 PHL
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
2. Special controls for 21 CFR 890.3480 Powered lower extremity exoskeleton. Standard may not fully address the requirements detailed in this regulation for applicable device types.


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Eric Franca
  CDRH/OSPTI/DAHRSSP/SCAP
  301-796-4505
  eric.franca@fda.hhs.gov
 Ozell Sanders
  FDA/CDRH/OPEQ/OHTV/DHTVB
  --
  Ozell.Sanders@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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