Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

Applies to X-ray equipment for computed tomography (CT scanners). Includes safety requirements for the X-ray generator, and those where high voltage generators are integrated with an X-ray tube assembly. Specify methods for demonstrating compliance with those requirements for CT scanners.

Medizinische elektrische Geräte - Teil 2-44: Besondere Festlegungen für die Sicherheit von Röntgeneinrichtungen für die Computer-Tomographie

Appareils électromédicaux - Partie 2-44: Règles particulières de sécurité pour les équipements à rayonnement X de tomodensitométrie

Applies to X-ray equipment for computed tomography (CT scanners). Includes safety requirements for the X-ray generator, and those where high voltage generators are integrated with an X-ray tube assembly. Specify methods for demonstrating compliance with those requirements for CT scanners.

Medicinska električna oprema - 2-44. del: Posebne varnostne zahteve za rentgensko opremo za računalniško podprto tomografijo (IEC 60601-2-44:2001)

General Information

Status
Withdrawn
Publication Date
08-Aug-2001
Withdrawal Date
30-Jun-2004
ICS
11.040.50 - Radiographic 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-May-2012
Completion Date
01-May-2012
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 60601-2-44:2002 - Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography (IEC 60601-2-44:2001)

Relations

Replaced By
EN 60601-2-44:2009 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Effective Date
29-Jan-2023
Referred By
EN 61223-3-5:2004 - Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
Effective Date
03-Feb-2026
Referred By
EN 61223-2-6:2007 - Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
Effective Date
03-Feb-2026
Amended By
EN 60601-2-44:2001/A1:2003 - Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
Effective Date
29-Jan-2023

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Frequently Asked Questions

EN 60601-2-44:2001 is a standard published by CLC. Its full title is "Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography". This standard covers: Applies to X-ray equipment for computed tomography (CT scanners). Includes safety requirements for the X-ray generator, and those where high voltage generators are integrated with an X-ray tube assembly. Specify methods for demonstrating compliance with those requirements for CT scanners.

Applies to X-ray equipment for computed tomography (CT scanners). Includes safety requirements for the X-ray generator, and those where high voltage generators are integrated with an X-ray tube assembly. Specify methods for demonstrating compliance with those requirements for CT scanners.

EN 60601-2-44:2001 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 60601-2-44:2001 has the following relationships with other standards: It is inter standard links to EN 60601-2-44:2009, EN 61223-3-5:2004, EN 61223-2-6:2007, EN 60601-2-44:2001/A1:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 60601-2-44:2001 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/432. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

EN 60601-2-44:2001 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)


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Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray
equipment for computed tomography (IEC 60601-2-44:2001)
Medizinische elektrische Geräte - Teil 2-44: Besondere Festlegungen für die Sicherheit
von Röntgeneinrichtungen für die Computer-Tomog
...

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