| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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056
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Date of Entry 06/07/2021
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|
FR Recognition Number
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3-129
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| Standard | |
ANSI AAMI EC53:2013/(R)2020
ECG trunk cables and patient leadwires |
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Scope/Abstract| The objective of this standard is to allow ECG TRUNK CABLES and PATIENT LEADWIRES to be interchanged between ECG DEVICES with isolated PATIENT connections by establishing a common interface between the TRUNK CABLE and the PATIENT LEADWIRE connectors. Performance and safety criteria for TRUNK CABLES and PATIENT LEADWIRES used with isolated PATIENT connectors are also specified. This standard's original scope related to TRUNK CABLES and PATIENT LEADWIRES used with cardiac monitors. The scope was extended to include PATIENT LEADWIRES used with other ECG DEVICES including diagnostic electrocardiographs, ambulatory ECG (Holter) recorders/event recorders and ECG telemetry. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
-Subclause 5.1.5 Optional labeling to identify accessories as not being DEFIBRILLATION-PROOF
-Subclause 5.3.1 Non-DEFIBRILLATION-PROOF TRUNK CABLES and PATIENT LEADWIRES
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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:
Subclause 5.1.5 is in conflict with other recognized standards, see subclause 201.6.2 and subclause 201.4.3.101 of IEC 60601-2-25 and IEC 60601-2-27.
Subclause 5.3.1 is in conflict with other recognized standards, see subclause 201.6.2 and subclause 201.4.3.101 of IEC 60601-2-25 and IEC 60601-2-27. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.2375 |
Monitor, Breathing Frequency
|
Class 2
|
BZQ
|
| §868.2377 |
Monitor, Apnea, Facility Use
|
Class 2
|
FLS
|
| §870.1025 |
Detector And Alarm, Arrhythmia
|
Class 2
|
DSI
|
| §870.1025 |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
Class 2
|
MHX
|
| §870.1025 |
Monitor, St Segment With Alarm
|
Class 2
|
MLD
|
| §870.2300 |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
Class 2
|
DRT
|
| §870.2300 |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
Class 2
|
MWI
|
| §870.2300 |
Low Patient Acuity Monitoring System
|
Class 2
|
PFY
|
| §870.2340 |
Electrocardiograph
|
Class 2
|
DPS
|
| §870.2340 |
Monitor, St Segment
|
Class 2
|
MLC
|
| §870.2800 |
Recorder, Magnetic Tape, Medical
|
Class 2
|
DSH
|
| §870.2800 |
Electrocardiograph, Ambulatory, With Analysis Algorithm
|
Class 2
|
MLO
|
| §870.2800 |
Electrocardiograph, Ambulatory (Without Analysis)
|
Class 2
|
MWJ
|
| §870.2900 |
Cable, Transducer And Electrode, Patient, (Including Connector)
|
Class 2
|
DSA
|
|
§870.2910
|
Radiofrequency physiological signal transmitter and receiver. Transmitters And Receivers, Physiological Signal, Radiofrequency
|
Class 2
|
DRG
|
| §870.5300 |
Dc-Defibrillator, High Energy, (Including Paddles)
|
Class 3
|
DRK
|
| §870.5300 |
Dc-Defibrillator, Low-Energy, (Including Paddles)
|
Class 2
|
LDD
|
| §870.5300 |
Atrial Defibrillator
|
Class 3
|
MPC
|
| §870.5310 |
Automated External Defibrillators (Non-Wearable)
|
Class 3
|
MKJ
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. 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.
2. 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)].
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 Contacts
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
