Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

Specifies the safety requirements for X-ray tube assemblies for medical diagnoses and components thereof, specified for use in medical X-ray equipment including equipment for computed tomography, that incorporates a specified high-voltage generator complying with HD 395.2.7 or HD 395.2.15.

Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von Röntgenstrahler einschließlich Blendensystem für medizinische Diagnostik

Appareils éléctromédicaux - Partie 2: Règles particulières de sécurité pour les ensembles radiogènes à rayonnement X et les gaines équipées pour diagnostic médical

Spécifie les prescriptions de sécurité pour les ensembles radiogènes à rayonnement X et les gaines équipées pour diagnostic médical et aux composants de ceux-ci, spécifiés pour utilisations dans un équipement à rayonnement X, y compris les équipements pour tomodensitométrie, qui comprennent un générateur radiologique spécifié en conformité avec HD 395.2.7 ou la HD 395.2.15

Medicinska električna oprema - 2. del: Posebne varnostne zahteve za vire rentgenskih žarkov in sklope rentgenskih cevi za medicinsko diagnostiko (IEC 60601-2-28:1993)

General Information

Status
Withdrawn
Publication Date
27-May-1993
Withdrawal Date
28-Feb-1994
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-Apr-2013
Completion Date
01-Apr-2013
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
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 60601-2-28:1995 - Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

Relations

Replaced By
EN 60601-2-28:2010 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Effective Date
28-Jan-2023
Replaced By
EN 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Effective Date
28-Jan-2023

Frequently Asked Questions

EN 60601-2-28:1993 is a standard published by CLC. Its full title is "Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis". This standard covers: Specifies the safety requirements for X-ray tube assemblies for medical diagnoses and components thereof, specified for use in medical X-ray equipment including equipment for computed tomography, that incorporates a specified high-voltage generator complying with HD 395.2.7 or HD 395.2.15.

Specifies the safety requirements for X-ray tube assemblies for medical diagnoses and components thereof, specified for use in medical X-ray equipment including equipment for computed tomography, that incorporates a specified high-voltage generator complying with HD 395.2.7 or HD 395.2.15.

EN 60601-2-28:1993 has the following relationships with other standards: It is inter standard links to EN 60601-2-28:2010, EN 60601-2-54:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 60601-2-28:1993 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023, 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 60601-2-28:1993 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)


SLOVENSKI STANDARD
01-maj-1995
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Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray
source assemblies and X-ray tube assemblies for medical diagnosis
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von
Röntgenstrahler einschließlich Blendensystem für medizinische Diagnostik
Appareils éléctromédicaux - Partie 2: Règles particulières de sécurité pour les
ensembles radiogènes à rayonnement X et les gaines équipées pour diagnostic médical
Ta slovenski standard je istoveten z: EN 60601-2-28:1993
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST
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