EN 60601-2-43:2010/A1:2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017)
16-04-2020
12-01-2013
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
Annex ZA (normative) Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) Coverage of Essential Requirements of
EC Directives
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.
| Committee |
TC 62
|
| DevelopmentNote |
To be read in conjunction with EN 60601-1:1990 (05/2001)
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN 60601-2-43:2002 | Identical |
| UNE-EN 60601-2-43:2010/A1:2018 | Identical |
| SN EN 60601-2-43 : 2000 | Identical |
| VDE 0750-2-43 : 2011 | Identical |
| NBN EN 60601 2-43 : 2010 | Identical |
| PN EN 60601-2-43 : 2010 AC 2014 | Identical |
| IEC 60601-2-43:2010+AMD1:2017 CSV | Identical |
| I.S. EN 60601-2-43:2010 | Identical |
| NF EN 60601-2-43 : 2011 | Identical |
| CEI EN 60601-2-43 : 2011/A1 : 2018 | Identical |
| OVE EN 60601-2-43: 2019 05 01 | Identical |
| DIN EN 60601-2-43 : 2011 | Identical |
| BS EN 60601-2-43:2010 | Identical |
| NEN EN IEC 60601-2-43 : 2010 C11 2014 | Identical |
| OVE/ONORM EN 60601-2-43 : 2011 | Identical |
| VDE 0750-2-43 : 2019-04 | Identical |
| DIN EN 60601-2-43 : 2019-04 | Identical |
| IEC 62220-1-1:2015 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging |
| 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 PAS 61910-1:2007 | Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 61910-1:2014 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
| 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 |
| 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 |
| EN 61910-1:2014 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
| 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 |
| EN 60601-2-54:2009/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| 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 |
| EN 60580:2000 | Medical electrical equipment - Dose area product meters |
| EN 62220-1:2004 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
| IEC 60601-2-44:2009+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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