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 31 S. KachelmeyerPPUB2011-022020

History

Stage
Document
Downloads
Decision Date
Target Date
AMW
62B/665/MCR PDF file 81 kB
2007-08-10 
1CD
62B/666/CD PDF file 548 kB
2007-08-112007-08
A2CD
62B/696A/CC Word file 462 kB
PDF file 361 kB
2008-03-142007-12
2CD
62B/721/CD PDF file 681 kB
2008-11-142008-11
ACDV
62B/770/CC Word file 783 kB
PDF file 439 kB
2009-10-302009-03
CCDV
62B/771/CDV PDF file 643 kB
PDF file 610 kB
2009-10-302009-10
AFDIS
62B/814/RVC Word file 659 kB
PDF file 517 kB
2010-10-012010-06
DECFDIS
2010-10-012010-10
RFDIS
2010-10-052010-10
CFDIS
62B/817/FDIS

2010-11-122011-01
APUB
62B/821/RVD PDF file 147 kB
2011-01-202011-01
APUB
62B/821A/RVD PDF file 236 kB
2011-01-202011-01
BPUB
2011-01-212011-01
PPUB
2011-02-102011-02
  

Abstract

IEC 60601-2-45:2011 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.

Project

IEC 60601-2-45:2011 ED3

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

 

 

Associated Documents:

62B/1000/RM

PDF file 130 kB