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CEI EN 60601-2-65 : 2013

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

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 60601-2-28 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
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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