| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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12-351
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| Standard | (Included in ASCA) |
IEC 60601-2-43 Edition 3.0 2022-12
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
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Scope/AbstractThis document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLYGUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:
- equipment for RADIOTHERAPY;
- equipment for COMPUTED TOMOGRAPHY;
- ACCESSORIES intended to be introduced into the PATIENT;
- mammographic XRAY EQUIPMENT;
- dental X-RAY EQUIPMENT.
NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONALX-RAY EQUIPMENT complying with this document is recommended, are given in Annex AA.
NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this document; therefore, no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements.
NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this document and not by IEC 60601-2-44 [1]1. No additional requirements for operation in cone-beam CT mode were identified for this document (see also Note 5 in 203.6.4.5).
INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENTSUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this document. If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAYEQUIPMENT 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 INTERVENTIONAL X-RAYEQUIPMENT and to ME SYSTEMS, as relevant.
IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply. |
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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. |
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Transition Period
| FDA recognition of IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION [Rec# 12-329] will be superseded by recognition of IEC 60601-2-43 Edition 3.0 2022-12 [Rec# 12-351]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-329] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 12-329] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §892.1650 |
System, X-Ray, Fluoroscopic, Image-Intensified
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Class 2
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JAA
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| §892.1650 |
Interventional Fluoroscopic X-Ray System
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Class 2
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OWB
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| §892.1680 |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
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Class 2
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MQB
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Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
2. Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray Imaging Devices Conformance with IEC Standards, Issued May 2019.
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. |
