International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62B

Diagnostic imaging equipment

 

Detail

Committee
Working Groups
Project Leader

Current

Status

Frcst Pub

Date

Stability

Date

SC 62BWG 37 U. KniesbergPPUB2008-022020

History

Stage
Document
Downloads
Decision Date
Target Date
1CD
62B/516/CD PDF file 7434 kB
2003-12-19 
AMW
62B/515/MCR PDF file 65 kB
2003-12-19 
ACDV
62B/523/CC PDF file 480 kB
2004-04-302004-04
A2CD
62B/523A/CC PDF file 400 kB
2004-08-062004-07
2CD
62B/547/CD PDF file 5548 kB
2004-10-292005-01
A3CD
62B/589/CC Word file 24 kB
PDF file 456 kB
2005-08-262005-03
3CD
62B/615/CD PDF file 2502 kB
2006-03-242005-10
ACDV
62B/632/CC Word file 765 kB
PDF file 472 kB
2006-08-182006-07
CCDV
62B/643/CDV PDF file 2561 kB
PDF file 2597 kB
2006-11-102006-12
AFDIS
62B/670/RVC Word file 623 kB
PDF file 299 kB
2007-09-142007-07
DECFDIS
2007-09-142007-09
RFDIS
2007-09-242007-09
CFDIS
62B/673/FDIS

2007-10-122007-12
APUB
62B/683/RVD PDF file 169 kB
2008-01-042007-12
BPUB
2008-01-182007-12
PPUB
2008-01-222008-01
 2020-07

Abstract

This collateral standard applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures. The object of this collateral standard is to establish general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the radiological procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the risk management process. This collateral standard considers radiation protection aspects related to X-radiation only. Requirements for the control of the electrical energy used to generate X-radiation, which is also an important aspect of radiation protection, are included in IEC 60601-1 and in particular standards for the safety and essential performance of the equipment concerned. This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994 (which replaced IEC 407 issued in 1973). It constitutes a technical revision. This edition has been restructured and aligned to IEC 60601-1(2005) and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C.

Project

IEC 60601-1-3:2008 ED2

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

 

 

Associated Documents:

62B/1175/RR

PDF file 94 kB
62B/1018/DC

PDF file 118 kB
62B/1000/RM

PDF file 130 kB
SMB/3264/DL

PDF file 211 kB