I.S. EN 60601-2-44:2009/A2:2016
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)
Hardcopy , PDF
English
21-06-2016
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.
Dates of withdrawal of national standards are available from NSAI.
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 |
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.