CAN/CSA-C22.2 No. 60601-2-65 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
Hardcopy , PDF
03-07-2020
English - French
01-01-2015
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FOREWORD
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
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME EQUIPMENT.
| DocumentType |
Standard
|
| ISBN |
978-1-4883-2141-2
|
| Pages |
145
|
| ProductNote |
NEW CHILD AMD 1 IS NOW ADDED
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy |
| 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 |
| 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 |
| 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 |
| 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 |
| 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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