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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 12-329
Standard(Included in ASCA pilot)
IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
Scope/Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED 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 X-RAY EQUIPMENT;
- dental X-RAY EQUIPMENT.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of IEC 60601-2-43 Edition 2.1[Rec# 12-308] will be superseded by recognition of IEC 60601-2-43 Edition 2.2 [Rec# 12-329]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-308] until December 25, 2022. After this transition period, declarations of conformity to [Rec# 12-308] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1650 Interventional Fluoroscopic X-Ray System Class 2 OWB
§892.1650 System, X-Ray, Fluoroscopic, Image-Intensified Class 2 JAA
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
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.
FDA Technical Contacts
 Scott Gonzalez
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-5889
  scott.gonzalez@fda.hhs.gov
 Donald Miller
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-3299
  Donald.Miller@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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