IEC TR 62348:2012
Current
The latest, up-to-date edition.
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
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
12-12-2012
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FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Assessment of the changes in Amendment 1:2012
5 Changes impacting many users of the standard
6 Changes impacting particular users of the standard
7 Mapping
Bibliography
IEC/TR 62348:2012(E) which is a technical report, provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012. This technical report also provides a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended. This report is intended to be used by:
- those who must align standards based on the second edition of IEC 60601-1 with the third edition as amended;
- manufacturers of medical electrical equipment or medical electrical systems; and
- health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems. This second edition cancels and replaces the first edition published in 2006. The second edition retains the mapping that traces the requirements of IEC 60601-1:2005 and its Amendment A1:2012 (Edition 3.1) from their source in the documents that relate to IEC 60601-1:1998 and its amendments (Edition 2.2). The second edition adds an assessment of the impact of the most significant changes in Amendment 1:2012.
| Committee |
TC 62/SC 62A
|
| DevelopmentNote |
Stability Date: 2019. (12/2012)
|
| DocumentType |
Technical Report
|
| Pages |
101
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NEN NPR IEC/TR 62348 : 2006 | Identical |
| CEI 62-143 : 2007 | Identical |
| BS EN 60601-2-43:2010 | Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures |
| 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 |
| EN 60601-2-43:2010/A1:2018 | 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) |
| I.S. EN 60601-2-43:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| CAN/CSA C22.2 No. 60601.2.43 : 2011(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| CSA C22.2 No. 60601.2.43 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| IEC 61558-2-15:2011 | Safety of transformers, reactors, power supply units and combinations thereof - Part 2-15: Particular requirements and tests for isolating transformers for the supply of medical locations |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV | Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 61558-1:2017 | Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
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