| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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3-105
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| Standard | (Included in ASCA) |
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 |
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Identical AdoptionANSI AAMI IEC 60601-2-25:2011/(R)2016
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
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Scope/AbstractIEC 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. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
- Subclause 201.12.1.101.2 Requirements for amplitude measurements
- Subclause 201.12.1.101.3.1 Requirements for absolute interval and wave duration measurements
- Subclause 201.12.1.101.3.2 Requirements for interval measurements on biological ECGs
- Subclause 202.6.2.6.1 Requirements, bb) exemption of patient cables |
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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:
- Subclauses 201.12.1.101.2, 201.12.1.101.3.1 and 201.12.1.101.3.2 are in conflict with methods for detection and management of outliers, see reference #2 listed below.
- 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 #4 listed below. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.2340 |
Electrocardiograph
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Class 2
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DPS
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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.
4. 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. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
