I.S. EN 60601-2-63:2015/A2:2021
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extraoral X-ray equipment (IEC 60601-2-63:2012/A2:2021)
Hardcopy , PDF
English
12-07-2021
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.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
FOREWORD
INTRODUCTION
2011 Scope, object and related standards
2012 Normative references
2013 Terms and definitions
2014 General requirements
2015 General requirements for testing of ME EQUIPMENT
2016 Classification of ME EQUIPMENT and ME SYSTEMS
2017 ME EQUIPMENT identification, marking and documents
2018 Protection against electrical HAZARDS from ME EQUIPMENT
2019 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
20110 Protection against unwanted and excessive radiation HAZARDS
20111 Protection against excessive temperatures and other HAZARDS
20112 Accuracy of controls and instruments and protection against hazardous
outputs
20113 HAZARDOUS SITUATIONS and fault conditions
20114 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
20115 Construction of ME EQUIPMENT
20116 ME SYSTEMS
20117 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility – Requirements and tests
203 Radiation protection in diagnostic X-ray equipment
Annexes
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS
Annex AA (informative) Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT.
| Committee |
TC 62
|
| DocumentType |
Standard
|
| Pages |
140
|
| ProductNote |
THIS STANDARD ALSO REFERS TO :-IEC/TR 60788:2004,IPSM 64:1991. The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 60601-2-63:2015/A2:2021 | 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.