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IEC 60601-2-49:2011

Superseded

Superseded

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

Available format(s)

Hardcopy , PDF

Language(s)

English, English - French

Published date

02-25-2011

Superseded date

03-08-2018

US$386.00
Excluding Tax where applicable
Summarise this standard

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

US$386.00
Excluding Tax where applicable