BS EN 60601-2-65:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Hardcopy , PDF
English
31-07-2013
30-04-2020
INTRODUCTION
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
202 Electromagnetic compatibility - Requirements
and tests
203 Radiation protection in diagnostic X-ray equipment
Annexes
Annex C (informative) - Guide to marking and labeling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Identification of parts of dental
X-RAY INTRA-ORAL SYSTEMS in relation
to defined terms in this standard
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME EQUIPMENT.
| Committee |
CH/62/2
|
| DevelopmentNote |
Partially supersedes BS EN 60601-2-7 & BS EN 60601-2-32. Supersedes 11/30227728 DC. (07/2013)
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.
| Standards | Relationship |
| EN 60601-2-65:2013 | Identical |
| IEC 60601-2-65:2012+AMD1:2017 CSV | Identical |
| IEC 60601-2-65:2012 | Identical |
| I.S. EN 60601-2-65:2013 | Equivalent |
| UNE-EN 60601-2-65:2013 | Equivalent |
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