• There are no items in your cart

I.S. EN 60601-2- 44:2009&A11:2011&A1:2012&A2:2016

Current

Current

The latest, up-to-date edition.

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009/A2:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-21-2016

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

FOREWORD
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive RADIATION HAZARDS
201.11 Protection against excessive temperatures and other HAZARDS
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
201.13 Hazardous situations and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS
203 General requirements for RADIATION protection in diagnostic X-ray equipment
Annexes
Annex AA (informative) Choosing LOADING FACTORS for tests
Annex BB (informative) Estimating CTDIvol for scan projection RADIOGRAPHY (SPR)
Bibliography

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT.

Committee
TC 62/SC 62B
DocumentType
Standard
ISBN
978-2-83220-304-0
Pages
192
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS ALSO REFERS TO IEC TR 60513
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
EN 60601-2-44:2009/A2:2016 Identical
IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Identical

View more information
US$114.68
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.