EURUSD
Your shopping cart is empty.
IEC

IEC 60601-2-33:2022/ISH2:2025

(Main)

Interpretation Sheet 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Interpretation Sheet 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Feuille d'interprétation 2 - Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical

General Information

Status
Published
Publication Date
17-Nov-2025
ICS
11.040.55 - Diagnostic equipment
Technical Committee
SC 62B - Medical imaging equipment, software, and systems
Current Stage
PPUB - Publication issued
Start Date
18-Nov-2025
Completion Date
12-Dec-2025
Ref Project

Relations

Revised
IEC 60601-2-33:2022 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Effective Date
26-Oct-2025
IEC 60601-2-33:2022/ISH2:2025 - Interpretation Sheet 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis Released:18. 11. 2025IEC 60601-2-33:2022/ISH2:2025 - Interpretation Sheet 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis Released:18. 11. 2025
PreviousNext
Standard
IEC 60601-2-33:2022/ISH2:2025 - Interpretation Sheet 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis Released:18. 11. 2025
English language
2 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)


INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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

INTERPRETATION SHEET 2
This interpretation sheet has been prepared by subcommittee 62B: Medical imaging
equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
The text of this interpretation sheet is based on the following documents:
DISH Report on voting
62B/1393/DISH 62B/1402/RVDISH
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.

___________
201.9.6.2.1.101 Acoustic noise requirements inside the MR EXAMINATION ROOM
The requirement is clarified as follows:
Exposure of the PATIENT, MR WORKERS and other persons is expressed as acoustic noise
emission value, produced by MR EQUIPMENT, or the emission levels specified. Thus, exposure
is not the sound level at or inside the ear, but the sound level to which the means for hearing
protection is exposed.
The compliance section is clarified as follows:
The following expression shall be evaluated:
99 + hearing protection value > L
Aeq,1h
where L is derived using the
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

IEC
IEC 62570:2025(Main)
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.
MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.

  • Standard
    18 pages
    English language
    sale 15% off
  • Standard
    27 pages
    French language
    sale 15% off
  • Standard
    45 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-37:2024(Main)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME 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 relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx,
b) technical and editorial changes as a result of maintenance to normative references;
c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.

  • Standard
    181 pages
    English language
    sale 15% off
  • Standard
    118 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-33:2022/ISH1:2023(Main)
Interpretation Sheet 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
  • Standard
    2 pages
    English language
    sale 15% off
IEC
IEC 60601-2-33:2022(Main)
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

IEC 60601-2-33:2022 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic resonance worker.
The contents of the Interpretation sheets 1 (2023-05) and 2 (2025-11) have been included in this copy.

  • Standard
    302 pages
    English and French language
    sale 15% off
IEC
IEC 62563-2:2021(Main)
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays

IEC 62563-2:2021 establishes the performance CRITERIA and test frequencies for the ACCEPTANCE TESTS and CONSTANCY TESTS. The evaluation methods are defined in IEC 62563-1. The scope of this document is directed to practical tests that can be visually evaluated or measured using basic test equipment. This document applies to medical IMAGE DISPLAY SYSTEMS, which can display monochrome image information in the form of greyscale values on colour and greyscale IMAGE DISPLAY SYSTEMS. This document does not apply to information displays and to displays used solely for control of technical settings of all medical information.

  • Standard
    71 pages
    English and French language
    sale 15% off
IEC
IEC 62563-1:2009/AMD2:2021(Amendment)
Amendment 2 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
  • Standard
    25 pages
    English and French language
    sale 15% off
IEC
IEC 62563-1:2009(Main)
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods

IEC 62563-1:2009 describes the evaluation methods for testing medical image display systems. It is directed to practical tests that can be visually evaluated or measured using basic test equipment. More advanced or more quantitative measurements can be performed on these devices, but these are beyond the scope of this document. IEC 62563-1:2009 applies to medical image display systems, which can display monochrome image information in the form of greyscale values on colour and greyscale image display systems (e.g. cathode ray tube (CRT) monitors, flat panel displays, projection system). This standard applies to medical image display systems used for diagnostic (interpretation of medical images toward rendering clinical diagnosis) or viewing (viewing medical images for medical purposes other than for providing a medical interpretation) purposes and therefore having specific requirements in terms of image quality. Head mounted image display systems and image display systems used for confirming positioning and for operation of the system are not covered by this standard.

  • Standard
    114 pages
    English and French language
    sale 15% off
  • Standard
    257 pages
    English and French language
    sale 15% off
  • Standard
    294 pages
    English and French language
    sale 15% off
IEC
IEC 63077:2019(Main)
Good refurbishment practices for medical imaging equipment

IEC 63077:2019 describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration.
The MEDICAL IMAGING EQUIPMENT and systems covered by this document include:
– X-RAY EQUIPMENT;
– X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES;
– X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY;
– MAGNETIC RESONANCE EQUIPMENT;
– ULTRASONIC DIAGNOSTIC EQUIPMENT;
– GAMMA CAMERAS;
– PLANAR WHOLEBODY IMAGING EQUIPMENT;
– equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT);
– SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT);
– POSITRON EMISSION TOMOGRAPHS (PET);
– PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT);
– PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT: and
– other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above.
This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems.
IEC 63077:2019 includes the following significant technical changes with respect to IEC PAS 63077:2016:
a) the scope was delineated more clearly;
b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added;
c) smaller corrections were performed.

  • Standard
    33 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-28:2017(Main)
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. 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 relevant. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included.

  • Standard
    73 pages
    English language
    sale 15% off
  • Standard
    48 pages
    English and French language
    sale 15% off
IEC
IEC 60601-2-65:2012/AMD1:2017(Amendment)
Amendment 1 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

Specifies the requirements for testing items of equipment intended for use on railway vehicles which are subsequently subjected to vibrations and chock owing to the nature of railway operational environment.

  • Standard
    9 pages
    English and French language
    sale 15% off