| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
|
065
|
Date of Entry 12/22/2025
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|
FR Recognition Number
|
3-203
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| Standard | (Included in ASCA) |
IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
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Scope/Abstract| IEC 80601-2-49:2018+AMD1:2024 CSV applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment. The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units. For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient. This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply. This document does not apply to implantable parts of multifunction patient monitors. This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Subclause 202.8.101 "IMMUNITY test setup" - Reference to table height (>= 0,4 m) for IMMUNITY testing in Figure 202.101. |
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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 202.8.101 "IMMUNITY test setup" reference to table height (>= 0,4 m from ground) for IMMUNITY testing in Figure 202.101 is in conflict with the distance of equipment to be tested and Mains/SIP/SOP cables to the ground plane specified in IEC 61000-4-6 for conducted IMMUNITY testing (e.g., IEC 61000-4-6, subclause 7.1 requiring that "equipment to be tested is placed on an insulating support of 0,1 m ± 0,05 m height above a reference ground plane"). See references #2 and #3 below. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5895 |
Ventilator, Continuous, Facility Use
|
Class 2
|
CBK
|
| §868.5895 |
Ventilator, Continuous, Non-Life-Supporting
|
Class 2
|
MNS
|
| §868.5895 |
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
|
Class 2
|
MNT
|
| §868.5915 |
Ventilator, Emergency, Manual (Resuscitator)
|
Class 2
|
BTM
|
| §868.5925 |
Ventilator, Emergency, Powered (Resuscitator)
|
Class 2
|
BTL
|
| §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 |
System, Network And Communication, Physiological Monitors
|
Class 2
|
MSX
|
| §870.2300 |
Multivariate Vital Signs Index
|
Class 2
|
PLB
|
| §870.2340 |
Monitor, St Segment
|
Class 2
|
MLC
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry - Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm), issued November 1998. [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cardiac-monitor-guidance-including-cardiotachometer-and-rate-alarm-guidance-industry]
2. IEC 61000-4-6 Edition 5.0 2023-06 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields.
3. IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
4. Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued June 2022. [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electromagnetic-compatibility-emc-medical-devices]
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 Organization
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FDA Specialty Task Groups (STG)
| Cardiovascular (primary) |
| Anesthesiology |
|
| *These are provided as examples and others may be applicable. |
