IEC 60601-2-33:2022

Title
Abstract

IEC 60601-2-33:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (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.

IEC 60601-2-33:2022 cancels and replaces the third edition published in 2010, Amendment 1:2013 and Amendment 2:2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) aligned with IEC 60601-1:2005 and its two amendments IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
b) addition of safety requirements for the EMERGENCY FIELD SHUT DOWN UNIT;
c) clarification of acoustic protection measures for the PATIENT and MR WORKER;
d) addition of noise emission declaration for exposure inside the MR EXAMINATION ROOM, to support occupational health assessment by the RESPONSIBLE ORGANIZATION;
e) addition of compliance methods for thermal safety of RF coils;
f) addition of RF transmit definitions to match MR CONDITIONAL labelling requirements for MEDICAL DEVICES;
g) clarification of requirements for MR CONDITIONAL labelling of ACCESSORIES;
h) alignment of static magnetic field limit for B0 HAZARD area to limits in other MEDICAL DEVICE standards (especially that for pacemakers, ISO 14117), the new limit value being 0,9 mT;
i) improved description of the magnetic field related plots in the Compatibility Technical Specification Sheet (CTSS);
j) provision of compatibility sequences (in the CTSS) to test auxiliary equipment by the MR manufacturer has become optional, and is expected to be eliminated in a future edition;
k) a separate section with requirements for a site-planning document containing safety information;
l) requirements for the alerting function (PATIENT to OPERATOR);
m) introduction of MROC as mandatory functionality for 1,5 T and 3 T systems to facilitate scanning of PATIENTs with MEDICAL DEVICES labelled as MR CONDITIONAL, unless such scanning is explicitly contra-indicated by the MR MANUFACTURER;
n) RF coil symbols in Table 201.A.102 have become mandatory, and the preferred and alternate signs have been swapped relative to the previous edition, with preferred now being the sign with color;
o) determination of the B1 stray field in 201.12.4.105.3.3 based on calculations only
The contents of the Interpretation Sheet 1 of May 2023 have been included in this copy.

Issue Date

2022-08-04

Category

MED

Included in IECEE System

2023-05-31

Purchase webstore
Test Report Form
Testing Equipment List

No information declared

DISCLAIMER: National differences

The National differences and Group differences, National Deviations and Special National conditions (SNC), are based solely on information provided to the Secretariat by the IECEE Member Bodies and/or NCBs and other sources. The IEC/IECEE is not responsible for, nor will it take any position related to, the accuracy or validity of the information provided. To verify the current status of this type of information, we recommend contacting the Member Body (MB) or National Certification Body (NCB) of the relevant country.

Group Differences are applicable for CENELEC member countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Group/Country

Reference

Last Modified

Differences

TRF Addendum

CanadaCanada

2024-06-24

Download53 kb

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13371

Kista

Sweden

13424

IL 60005

United States of America

13334

BRUSSELS 1070

Belgium

13349

Budapest

Hungary

13346

München

Germany

No information declared