IEC 60601-2-29:2008
Current
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
Hardcopy , PDF
English - French
06-11-2008
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
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and
ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
IEC 60601-2-29:2008 establishes requirements to be complied with by manufacturers in the design and construction of radiotherapy simulators; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an interlock then operates to prevent continued operation of the medical electrical equipment. This third edition cancels and replaces the second edition published in 1999. This edition constitutes a technical revision, which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.
| Committee |
TC 62/SC 62C
|
| DevelopmentNote |
Stability Date: 2020. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
49
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DS EN 60601-2-29 : 2009 AMD 11 2011 | Identical |
| GOST R IEC 60601-2-29 : 2013 | Identical |
| NEN EN IEC 60601-2-29 : 2009 AMD 11 2011 | Identical |
| AS/NZS IEC 60601.2.29:2015 | Identical |
| VDE 0750-2-29:2009-06 | Identical |
| NEN-EN-IEC 60601-2-29:2009 | Identical |
| IS 13450 : Part 2 : Sec 29 : 2018 | Identical |
| BIS IS 13450-2-29 : 2008 | Identical |
| BS EN 60601-2-29 : 2008 | Identical |
| I.S. EN 60601-2-29:2008 | Equivalent |
| CEI EN 60601-2-29 : 2011 | Identical |
| CEI EN 60601-2-29 : 2010 | Identical |
| UNE-EN 60601-2-29:2009 | Identical |
| PN EN 60601-2-29 : 2009 AMD 11 2011 | Identical |
| I.S. EN 60601-2-29:2008 | Identical |
| BS EN 60601-2-29:2008+A11:2011 | Identical |
| ABNT NBR IEC 60601-2-29:2018 | Identical |
| NF EN 60601-2-29 : 2009 AMD 11 2012 | Identical |
| DIN EN 60601-2-29:2009-06 | Identical |
| BS 5724-2.129(1993) : 1993 AMD 9201 | Identical |
| NEN 10601-2-29 : 96 AMD 1 97 | Identical |
| BS 5724-2.129:SUPP1(1997) : 1997 | Identical |