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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 030 Date of Entry 01/25/2013 
FR Recognition Number 3-105
Standard(Included in ASCA pilot)
IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
U.S. Identical Adoption
ANSI AAMI ISO 60601-2-25 Edition 2.0 2011-10
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
Scope/Abstract
EC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are:
a) the part of Medical electrical equipment that provides vectorcardiographic loops;
b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes;
c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes.
This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Clauses 201.12.1.101.2 Requirements for amplitude measurements

Clause 201.12.1.101.3.1 Requirements for absolute interval and wave duration
measurements

Clause 201.12.1.101.3.2 Requirements for interval measurements on biological ECGs
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.

Clause 201.12.1.101.2, Clause 201.12.1.101.3.1, and Clause 201.12.1.101.3.2 are in conflict with methods for detection and management of outliers, see article 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. Rosner, B.(1983), Percentage Points for a Generalized ESD Many-Outlier Procedure. Technometrics, 25 (2), 165-172.

3. Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement) - Guidance for Industry, Issued November 1998.
FDA Technical Contact
 Shawn Forrest
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-5554
  shawn.forrest@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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