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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 12-347
Standard(Included in ASCA)
IEC  60601-2-33 Edition 4.0 2022-08
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Scope/Abstract
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETICRESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS.
NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate MR EQUIPMENT and MR SYSTEMS.

This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE.

If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR 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 MR EQUIPMENT and to MR SYSTEMS, as relevant.

This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS
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FDA recognition of IEC 60601-2-33 Ed. 3.2 b:2015 [Rec# 12-295] will be superseded by recognition of IEC 60601-2-33 Edition 4.0 2022-08 [Rec# 12-347]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-295] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 12-295] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1000 System, Nuclear Magnetic Resonance Spectroscopic Class 2 LNI
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
§892.1000 Mri Disposable Kit Class 2 OIM
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series

Guidance for Industry and Food and Drug Administration Staff: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, Issued November 2016.

Guidance for Industry and Food and Drug Administration Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices, Issued June 2014.

Guidance for Industry and Food and Drug Administration Staff: Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway. Issued December 2020

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Daniel Krainak
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/
  301-796-0478
  Daniel.Krainak@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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