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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 043 Date of Entry 06/27/2016 
FR Recognition Number 5-89
Standard(Included in ASCA)
IEC  60601-1-6 Edition 3.1 2013-10
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Scope/Abstract
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.

If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).
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.
Transition Period
FDA recognition of IEC 60601-1-6 Edition 3.1 2013-10 [Rec# 5-89] will be superseded by recognition of IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION [Rec# 5-132]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 5-89] until December 17, 2023. After this transition period, declarations of conformity to [Rec # 5-89] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Issued February 2016.

3. AAMI TIR50:2014 Post-market surveillance of use error management.


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 Contact
 Janine Purcell
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-2059
  Janine.Purcell@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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