iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CLC

EN 60601-2-33:2002/A2:2008

(Amendment)

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

Corrigendum to EN issued November 2008 * Superseded by EN 60601-2-33:2010

Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik

Appareils électromédicaux - Partie 2-33: Règles particulières de sécurité relatives aux appareils à résonance magnétique utilisés pour le diagnostic médical

Medicinska električna oprema - 2-33. del: Posebne varnostne zahteve za opremo za magnetno resonanco za medicinsko diagnostiko (IEC 60601-2-33:2002/A2:2007)

General Information

Status
Withdrawn
Publication Date
04-Mar-2008
Withdrawal Date
31-Jan-2011
ICS
11.040.55 - Diagnostic equipment
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
IEC/SC 62B - IEC_SC_62B
Parallel Committee
IEC/SC 62B - IEC_SC_62B
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
01-Oct-2013
Completion Date
01-Oct-2013
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
Ref Project
SIST EN 60601-2-33:2003/A2:2008 - Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002/A2:2007)

Relations

Replaced By
EN 60601-2-33:2010 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Effective Date
29-Jan-2023
Amends
EN 60601-2-33:2002 - Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
Effective Date
29-Jan-2023

Buy Standard

EN 60601-2-33:2003/A2:2008EN 60601-2-33:2003/A2:2008
PreviousNext
Amendment
EN 60601-2-33:2003/A2:2008
English language
21 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-33:2003/A2:2008
01-maj-2008
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DRSUHPR
]DPDJQHWQRUHVRQDQFR]DPHGLFLQVNRGLDJQRVWLNR ,(&$
Medical electrical equipment - Part 2-33: Particular requirements for the safety of
magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002/A2:2007)
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit
von Magnetresonanzgeräten für die medizinische Diagnostik (IEC 60601-2-
33:2002/A2:2007)
Appareils électromédicaux - Partie 2-33: Règles particulières de sécurité relatives aux
appareils à résonance magnétique utilisés pour le diagnostic médical (CEI 60601-2-
33:2002/A2:2007)
Ta slovenski standard je istoveten z: EN 60601-2-33:2002/A2:2008
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-33:2003/A2:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN 60601-2-33/A2

NORME EUROPÉENNE
March 2008
EUROPÄISCHE NORM

ICS 11.040.55


English version


Medical electrical equipment -
Part 2-33: Particular requirements for the safety
of magnetic resonance equipment for medical diagnosis
(IEC 60601-2-33:2002/A2:2007)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-33: Règles particulières Teil 2-33: Besondere Festlegungen für die
de sécurité relatives aux appareils Sicherheit von Magnetresonanzgeräten
à résonance magnétique utilisés für die medizinische Diagnostik
pour le diagnostic médical (IEC 60601-2-33:2002/A2:2007)
(CEI 60601-2-33:2002/A2:2007)




This amendment A2 modifies the European Standard EN 60601-2-33:2002; it was approved by CENELEC on
2008-02-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CENELEC member into its own language and notified to the
Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-33:2002/A2:2008 E

---------------------- Page: 2 ----------------------

EN 60601-2-33:2002/A2:2008 – 2 –
Foreword
The text of document 62B/663/FDIS, future amendment 2 to IEC 60601-2-33:2002, prepared by SC 62B,
Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to
the IEC-CENELEC parallel vote and was approved by CENELEC as amendment A2 to
EN 60601-2-33:2002 on 2008-02-01.
The following dates were fixed:
– latest date by which the amendment has to be
implemented at national level by publication of
an identical national standard or by endorsement (dop) 2008-11-01
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2011-02-01
__________
Endorsement notice
The text of amendment 2:2007 to the International Standard IEC 60601-2-33:2002 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________

---------------------- Page: 3 ----------------------

IEC 60601-2-33
Edition 2.0 2007-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 2
AMENDEMENT 2
Medical electrical equipment –
Part 2-33: Particular requirements for the safety of magnetic resonance
equipment for medical diagnosis

Appareils électromédicaux –
Partie 2-33: Règles particulières de sécurité relatives aux appareils à résonance
magnétique utilisés pour le diagnostic médical

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
R
CODE PRIX
ICS 11.040.55 ISBN 2-8318-9358-5

---------------------- Page: 4 ----------------------

– 2 – 60601-2-33 Amend.2 © IEC:2007
FOREWORD
This amendment has b
...

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

CLC
EN IEC 80601-2-26:2020/A1:2024(Amendment)
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
SIST EN IEC 80601-2-26:2020/A1:2024
  • Draft
    38 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 61676:2023/AC:2024-02(Corrigendum)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of x-ray tube voltage in diagnostic radiology
SIST EN IEC 61676:2023/AC:2024
  • Corrigendum
    3 pages
    English and French language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 61676:2023(Main)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
SIST EN IEC 61676:2023

IEC 61676:2023 is available as IEC 61676:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61676:2023 specifies the performance requirements of instruments as used in the non-invasive measurement of X-RAY tube voltage up to 150 kV and the relevant compliance tests. This document also describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. Applications for such measurement are found in diagnostic radiology including mammography, computed tomography (CT), dental radiology and radioscopy. This document is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1. IEC 61676:2023 cancels and replaces first edition published in 2002, Amendment 1:2008. This edition constitutes a technical revision. It includes an assessment of the combined standard uncertainty for the performance of a hypothetical instrument for the non-invasive measurement of the tube high voltage (in Annex A) which replaces Annex A of the edition 1.1 titled "Recommended performance criteria for the invasive divider".

  • Standard
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 80601-2-59:2019/A1:2023(Amendment)
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
SIST EN IEC 80601-2-59:2019/A1:2023

20211012-JO-Link to 93/42/EEC and M/295 removed

  • Amendment
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 62563-2:2021(Main)
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
SIST EN IEC 62563-2:2022

This part of IEC 62563 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
    38 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-41:2021(Main)
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
SIST EN IEC 60601-2-41:2022

IEC 60601-2-41:2021 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter 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. This particular standard does not apply to – headlights; – endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18; – luminaires used in dentistry, which are covered by ISO 9680; – luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4; – luminaires dedicated to therapeutic purposes; – special purpose lights with different conditions of use such as light sources intended solely for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; – lights connected to surgical instruments, such as luminous retractors; – luminaires for emergency lighting, which are covered by IEC 60598-2-22. SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment. IEC 60601-2-41:2021 cancels and replaces the second edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revised the statement of essential performance; b) added exposure limits, test conditions, calculation methods and safety warnings related to photobiological hazards; c) removed the terms “MINOR SURGICAL LUMINAIRES” and “MAJOR SURGICAL LUMINAIRES”; d) added definitions of MAXIMUM ILLUMINANCE DISTANCE and REFERENCE DISTANCE and allowed MANUFACTURERS to measure some performance characteristics at the REFERENCE DISTANCE that they specify; e) replaced the region of acceptable chromaticity in (x,y) colour space with a requirement for Du,v; f) added a requirement for acceptable drift of the lighthead when attached to the suspension system; g) added a requirement for fluid ingress protection; h) revised Table 201.101 of IEC 60601-2-41:2009 and IEC 60601-2-41:2009/AMD1:2013 and moved it to Annex BB; i) specified a new device for measuring SHADOW DILUTION in a simulated cavity; j) specified test conditions for luminaires equipped with distance sensors.

  • Standard
    63 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 62563-1:2010/A2:2021(Amendment)
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
SIST EN 62563-1:2010/A2:2021
  • Amendment
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 80601-2-26:2020(Main)
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
SIST EN IEC 80601-2-26:2020

IEC 80601-2-26:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: – phono-photic stimulators; – EEG data storage and retrieval; – ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or 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 follows. The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. 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. IEC 80601-2-26:2019 cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto.

  • Standard
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 63077:2019(Main)
Good refurbishment practices for medical imaging equipment
SIST EN IEC 63077:2020

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
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 80601-2-59:2019(Main)
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
SIST EN IEC 80601-2-59:2019

IEC 80601-2-59:2017 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. This document sets laboratory characterization test limits for the screening thermograph. This edition includes the following significant technical changes with respect to the previous edition: a) updates of the normative references and the bibliography; b) expansion of the applicability to pandemic infectious diseases in general.

  • Standard
    44 pages
    English language
    sale 10% off
    e-Library read for
    1 day