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
Current Stage
PPUB - Publication issued
Start Date
18-Nov-2025
Completion Date
12-Dec-2025

Relations

Effective Date
26-Oct-2025

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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:11/18/2025

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Frequently Asked Questions

IEC 60601-2-33:2022/ISH2:2025 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "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". This standard covers: 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

IEC 60601-2-33:2022/ISH2:2025 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

IEC 60601-2-33:2022/ISH2:2025 has the following relationships with other standards: It is inter standard links to IEC 60601-2-33:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

IEC 60601-2-33:2022/ISH2:2025 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

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
...

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