CEI EN 60601-2-65 : 2013
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
Hardcopy , PDF
English
01-01-2013
FOREWORD
INTRODUCTION
1. SCOPE, OBJECT AND RELATED STANDARDS
2. NORMATIVE REFERENCES
3. TERMS AND DEFINITIONS
4. GENERAL REQUIREMENTS
5. GENERAL REQUIREMENTS FOR TESTING ME
EQUIPMENT
6. CLASSIFICATION OF ME EQUIPMENT AND ME
SYSTEMS
7. ME EQUIPMENT IDENTIFICATION, MARKING
AND DOCUMENTS
8. PROTECTION AGAINST ELECTRICAL HAZARDS
FROM ME EQUIPMENT
9. PROTECTION AGAINST MECHANICAL HAZARDS
OF ME EQUIPMENT AND ME SYSTEMS
10. PROTECTION AGAINST UNWANTED AND
EXCESSIVE RADIATION HAZARDS
11. PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER HAZARDS
12. ACCURACY OF CONTROLS AND INSTRUMENTS AND
PROTECTION AGAINST HAZARDOUS OUTPUTS
13. HAZARDOUS SITUATIONS AND FAULT CONDITIONS
14. PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
15. CONSTRUCTION OF ME EQUIPMENT
16. ME SYSTEMS
17. ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT
AND ME SYSTEMS
202. ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
203. RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
ANNEX
ANNEX C (INFORMATIVE) - GUIDE TO MARKING AND LABELLING
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
ANNEX ZA (NORMATIVE) - NORMATIVE REFERENCES
TO INTERNATIONAL PUBLICATIONS
WITH THEIR CORRESPONDING
EUROPEAN PUBLICATIONS
ANNEX ZZ (INFORMATIVE) - COVERAGE OF ESSENTIAL
REQUIREMENTS OF EC DIRECTIVES
Describes the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME EQUIPMENT.
Committee |
CT 62
|
DevelopmentNote |
Classificazione CEI 62-235. To be read in conjunction with CEI EN 60601-1. (12/2013) NEW CHILD AMD 1 2020 IS NOW ADDED. New child AMD 2 2022 is added.
|
DocumentType |
Standard
|
Pages |
62
|
ProductNote |
NEW CHILD AMD 1 2020 IS NOW ADDED. New child AMD 2 2022 is added.
|
PublisherName |
Comitato Elettrotecnico Italiano
|
Status |
Current
|
Standards | Relationship |
EN 60601-2-65:2013 | Identical |
IEC 60601-2-65:2012+AMD1:2017 CSV | Identical |
IEC 60601-2-7:1998 | Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators |
IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
EN 60601-1-3 : 2008 AMD 11 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013) |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
IEC 60601-2-54:2009+AMD1:2015 CSV | Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
IEC 62220-1:2003 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
IEC 60601-2-32:1994 | Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment |
EN 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
IEC 60601-2-43:2010+AMD1:2017 CSV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
IEC 60601-2-63:2012+AMD1:2017 CSV | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
EN 62220-1:2004 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
IEC 60601-2-45:2011+AMD1:2015 CSV | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
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