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BS EN 60601-2-65:2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Available format(s)

Hardcopy , PDF

Superseded date

04-30-2020

Language(s)

English

Published date

07-31-2013

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.

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.

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

Standards Relationship
EN 60601-2-65:2013 Identical
IEC 60601-2-65:2012+AMD1:2017 CSV Identical
IEC 60601-2-65:2012 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
IEC 60601-2-28:2017 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
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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