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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 061 Date of Entry 12/18/2023 
FR Recognition Number 3-126
Standard(Included in ASCA)
IEC  60601-2-27 Edition 3.0 2011-03
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
Identical Adoption
ANSI AAMI IEC 60601-2-27:2011(R)2016
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Scope/Abstract
This standard specifies basic safety requirements and essential performance for electrocardiographic (ECG) monitoring equipment. It is applicable to ECG monitoring equipment used in a hospital environment. If it is used outside the hospital environment, such as in ambulances and air transport, the ECG monitoring equipment shall comply with this standard. This standard is not applicable to electrocardiographic monitors for home use and ECG telemetry systems. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use/intended purpose. Ambulatory ("Holter") monitors, fetal heart rate monitors, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
- Subclause 202.6.2.6.1 Requirements, bb) exemption of patient cables
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:

- Subclause 202.6.2.6.1 bb) (exemption of patient cables) is in conflict with FDA recognized standard IEC 60601-1-2 Edition 4.1, Annex D.3 c) requesting particular standards to not exempt PATIENT cables from this testing. See reference #3 listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.2340 Electrocardiograph Class 2 DPS
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. AAMI/ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).

3. IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

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
 Loriano Galeotti
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-5279
  Loriano.Galeotti@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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