CAN/CSA C22.2 No. 60601.2.43 : 2011(R2016)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
Hardcopy , PDF
25-09-2021
English
01-01-2016
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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 AA (informative) - Particular guidance and rationale
Annex BB (normative) - Distribution maps of STRAY RADIATION
Annex CC (informative) - Mapping between this Edition 2 of
IEC 60601-2-43 and Edition 1
Bibliography
Index of defined terms used in this particular standard
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT.
| DocumentType |
Revision
|
| Pages |
251
|
| ProductNote |
Reconfirmed EN THIS STANDARD ALSO REFERS TO CAN/CSA-C22.2 No. 0-10, CAN/CSA-C22.2 No. 60601-1:14
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| Standards | Relationship |
| IEC 60601-2-43:2010+AMD1:2017 CSV | Identical |
| NEMA PS3.3 : 2017A | DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) - PART 3: INFORMATION OBJECT DEFINITIONS |
| IEC PAS 61910-1:2007 | Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| NEMA XR 24-2008 (R2014) | PRIMARY USER CONTROLS FOR INTERVENTIONAL ANGIOGRAPHY X-RAY EQUIPMENT |
| 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 62220-1:2003 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
| IEC 60580:2000 | Medical electrical equipment - Dose area product meters |
| 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 TR 62348:2012 | Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition |
| NEMA PS 3.16 : 2017A | DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) - PART 16: CONTENT MAPPING RESOURCE |
| 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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