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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 055 Date of Entry 12/21/2020 
FR Recognition Number 19-38
Standard(Included in ASCA pilot)
IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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.

The HOME HEALTHCARE ENVIRONMENT includes:
- the dwelling place in which a PATIENT lives;
- other places where PATIENTS are present both indoors and outdoors, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present.

This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
"Note 2 to entry" in Sub-clause 3.1 (Home Healthcare Environment).

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.

This standard is recognized in part because: "Note 2 to entry" in Sub-clause 3.1 (Home Healthcare Environment) is in conflict with existing published final guidance. See "professional healthcare facility" of IV. Definitions in reference #3 listed below.
Transition Period
FDA recognition of IEC 60601-1-11 Edition 2.0 2015-01 [Rec# 19-14] will be superseded by recognition of IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION [Rec# 19-38]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 19-14] until December 17, 2023. After this transition period, declarations of conformity to [Rec # 19-14] 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.
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 Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.
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