IEC 60601-2-49:2011
Superseded
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
Hardcopy , PDF
English, English - French
02-25-2011
03-08-2018
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
208 General requirements, tests and guidance for
alarm systems in medical electrical equipment
and medical electrical systems
Annexes
Annex AA (informative) - General guidance and rationale
Annex BB (informative) - Alarm diagrams of Clause 208/IEC
60601-1-8:2006
ANNEX CC (informative) - Examples of the connection of the
measuring device (MD) for measurement of the
PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY
CURRENT
Bibliography
Index of defined terms used in this particular standard
IEC 60601-2-49:2011 applies to the basic safety and essential performance requirements of multifunction patient monitoring equipment. It applies to medical electrical equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Medical electrical equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to me equipment for those environments of use. The scope of this standard is restricted to medical electrical equipment intended for connection to a single patient that has either two or more applied parts or multiple functions on an applied part. This second edition cancels and replaces the first edition of IEC 60601-2-49, published in 2001. This edition constitutes a technical revision to the new structure of IEC 60601-1:2005 (third edition).
| Committee |
TC 62/SC 62D
|
| DevelopmentNote |
Stability Date: 2018. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
110
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| NEN EN IEC 60601-2-49 : 2015 | Identical |
| I.S. EN 60601-2-49:2015 | Identical |
| PN EN 60601-2-49 : 2016 | Identical |
| DIN EN 60601-2-49 : 2016 | Identical |
| VDE 0750-2-49 : 2016 | Identical |
| IS 13450 : Part 2 : Sec 49 : 2018 | Identical |
| BS EN 60601-2-49:2015 | Identical |
| CEI EN 60601-2-49 : 2016 | Identical |
| EN 60601-2-49:2015 | Identical |
| UNE-EN 60601-2-49:2016 | Identical |