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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 19-16
Standard(Included in ASCA pilot)
ANSI AAMI HA60601-1-11:2015
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD)
Scope/Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained
healthcare personnel.
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FDA recognition of ANSI/AAMI HA60601-11:2015 [Rec# 19-16] will be superseded by recognition of ANSI/AAMI HA60601-1-11:2015 [Including AMD1:2021] [Rec# 19-47]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 19-16] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 19-16] will not be accepted
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices, Issued February 3, 2016.

3. Guidance for Industry and Food and Drug Administration Staff: Design Considerations for Devices Intended for Home Use, Issued November 24, 2014.

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
 Aftin Ross
  FDA/OC/CDRH/OSPTI/DAHRSSP/AHRRC/
  301-794-5679
  Aftin.Ross@fda.hhs.gov
 Joann Brumbaugh
  FDA/OMPT/CDRH/OSB
  301-796-6543
  joann.brumbaugh@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.
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