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CSA - CAN/CSA-C22.2 NO. 60601-2-43:03

Medical electrical equipment Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures

inactive
Organization: CSA
Publication Date: 1 June 2003
Status: inactive
Page Count: 46
scope:

Addition:

This Particular Standard applies to X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Its scope excludes, in particular:

- equipment for RADIOTHERAPY;

- equipment for COMPUTED TOMOGRAPHY;

- ACCESSORIES intended to be introduced into the PATIENT;

- mammographic X-RAY EQUIPMENT.

NOTE 1 Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of EQUIPMENT complying with this standard is recommended, are given in annex BB.

NOTE 2 The particular requirements of this standard are not essential for EQUIPMENT used in all RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Examples of procedures, for which the use of EQUIPMENT complying with this standard is considered not to be essential, are given in annex BB.

EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard.

Document History

CAN/CSA-C22.2 NO. 60601-2-43:11
January 1, 2022
Medical electrical equipment — Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED...
CAN/CSA-C22.2 NO. 60601-2-43:11 AMD 2
January 1, 2021
Medical electrical equipment — Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED...
CAN/CSA-C22.2 NO. 60601-2-43:11
January 1, 2019
Medical electrical equipment — Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
This Standard covers ME EQUIPMENT that is intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.
CSA C22.2 NO 60601-2-43
January 1, 2019
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures - Amendment 1
This Standard covers INTERVENTIONAL X-RAY EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.
CAN/CSA-C22.2 NO. 60601-2-43:11 AMD 1
January 1, 2019
Medical electrical equipment — Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
This Standard covers INTERVENTIONAL X-RAY EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.
CAN/CSA-C22.2 NO. 60601-2-43:11
January 1, 2019
Medical electrical equipment — Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
A description is not available for this item.
CAN/CSA-C22.2 NO. 60601-2-43:11
November 1, 2011
Medical electrical equipment — Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED...
CSA C22.2 NO 60601-2-43
January 1, 2011
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES,...
CAN/CSA-C22.2 NO. 60601-2-43:11
January 1, 2011
Medical electrical equipment — Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES,...
CAN/CSA-C22.2 NO. 60601-2-43:03
June 1, 2003
Medical electrical equipment Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
A description is not available for this item.
CAN/CSA-C22.2 NO. 60601-2-43:03
June 1, 2003
Medical electrical equipment Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
Addition: This Particular Standard applies to X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Its scope excludes, in...
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References

This document references:
IEC/TR 60788 - Medical electrical equipment Glossary of defined terms
Published by IEC on February 1, 2004
This Technical report comprises all defined terms used in the IEC standards and technical reports which – fall under the scope of MEDICAL ELECTRICAL EQUIPMENT, and – are on the list of publications...
This document references:
IEC 60601-2-28 - Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Published by IEC on June 1, 2017
Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof, intended for medical diagnosis and imaging. Where the...
This document references:
IEC 60529 - Degrees of Protection Provided by Enclosures (IP Code)
Published by IEC on August 1, 2013
This standard applies to the classification of degrees of protection provided by enclosures for electrical equipment with a rated voltage not exceeding 72,5 kV.
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