IEC 60601-2-46:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-46: Particular requirements for the basic safety and essential performance of operating tables
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
26-05-2023
English - French
10-08-2016
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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 OPERATING
TABLES
201.6 Classification of OPERATING TABLES and
ME SYSTEMS
201.7 OPERATING TABLES identification, marking
and documents
201.8 Protection against electrical HAZARDS from
OPERATING TABLES
201.9 Protection against MECHANICAL HAZARDS
of OPERATING TABLES 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 for OPERATING TABLES
201.14 PROGRAMMABLE ELECTRICAL MEDICAL
SYSTEMS (PEMS)
201.15 Construction of OPERATING TABLES
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of OPERATING
TABLES and ME SYSTEMS
202 Electromagnetic disturbances - Requirements and tests
203 Radiation protection in diagnostic X-ray equipment
Annexes
Annex G (normative) - Protection against HAZARDS of
ignition of flammable anaesthetic mixtures
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
IEC 60601-2-46:2016 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the operating table top to or from the base or pedestal of an operating table with detachable operating table top. This third edition cancels and replaces the second edition published in 2010 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1 and with IEC 60601-1:2005/AMD1:2012.
| Committee |
TC 62/SC 62D
|
| DevelopmentNote |
Stability Date: 2021. (08/2016)
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-3565-2
|
| Pages |
50
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN IEC 60601-2-46:2019 | Identical |
| OVE EN IEC 60601-2-46: 2020 05 01 | Identical |
| I.S. EN IEC 60601-2-46:2019 | Identical |
| BS EN IEC 60601-2-46:2019 | Identical |
| NEN-EN-IEC 60601-2-46:2019 | Identical |
| UNE-EN IEC 60601-2-46:2019 | Identical |
| DIN EN IEC 60601-2-46 :2020-04 | Identical |
| VDE 0750-2-46:2020-04 | Identical |
| NF EN IEC 60601-2-46:2019 | Identical |
| CEI EN IEC 60601-2-46:2020 | Identical |
| IS 13450 : Part 2 : Sec 46 : 2020 | Identical |
| UNE-EN 60601-2-46:2000 | Identical |
| CSA C22.2 No. 60601.2.46 : 2012 | Identical |
| I.S. EN 60601-2-46:2011 | Identical |
| CSA C22.2 No. 60601.2.46 : 2012 : R2016 | Identical |
| DIN EN 60601-2-46 : 2011 | Identical |
| VDE 0750-2-46 : 2011 | Identical |
| EN 60601-2-46:2011 | Identical |
| BS EN 60601-2-46:2011 | Identical |
| PNE-FprEN 60601-2-46 | Identical |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 11073-10406:2012 | Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
| PD IEC/TR 60601-4-3:2015 | Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements |
| I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| 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 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| IEC 60601-2-52:2009+AMD1:2015 CSV | Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds |
| 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 |
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