| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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FR Recognition Number
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3-202
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| Standard | (Included in ASCA) |
IEC 60601-2-34 Edition 4.0 2024-10
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
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Scope/AbstractThis part of IEC 60601 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as ME EQUIPMENT.
This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use in professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT.
This document does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME.
This document does not apply to non-invasive blood pressure monitoring equipment.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows:
The clause or subclause applies to ME EQUIPMENT, as default and, only if the corresponding safety measure or function is not completely integrated into the ME EQUIPMENT but implemented as part of an ME SYSTEM, the clause or subclause applies to the ME SYSTEM. |
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| Extent of Recognition
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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.
NOTE:
Re. subclause 201.12.1.101.3, if you choose to test with an electrical simulated pressure source, contact the review division prior to testing to discuss: a) your proposed approach to "demonstrate that the ME EQUIPMENT in combination with the respective PRESSURE TRANSDUCER complies with the requirements of 201.12.1.101.3" and b) the electrical simulated pressure test methods that you propose to use "to check the frequency response of the ME EQUIPMENT excluding the pressure transducer." |
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Transition Period
| FDA recognition of IEC 60601-2-34 Edition 3.0 2011-05 [Rec# 3-115] will be superseded by recognition of IEC 60601-2-34 Edition 4.0 2024-10 [Rec# 3-202]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-115] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 3-115] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.1110 |
Computer, Blood-Pressure
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Class 2
|
DSK
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| §870.2060 |
Amplifier And Signal Conditioner, Transducer Signal
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Class 2
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DRQ
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| §870.2850 |
Transducer, Blood-Pressure, Extravascular
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Class 2
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DRS
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| §870.2870 |
Transducer, Pressure, Catheter Tip
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Class 2
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DXO
|
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Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
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 Group (STG)
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| *These are provided as examples and others may be applicable. |
