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EN 60601-2-24:2015

Current
Current

The latest, up-to-date edition.

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
Published date

05-22-2015

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
206 Usability
208 General requirements, tests and guidance for alarm
    systems in medical electrical equipment and medical
    electrical systems
Annexes
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

IEC 60601-2-24:2012 applies to the basic safety and essential performance of infusion pumps and volumetric infusion controllers. This standard applies to administration sets insofar as their characteristics influence the basic safety or essential performance of infusion pumps and volumetric infusion controllers. However this standard does not specify requirements or tests for other aspects of administration sets. This particular standard specifies the requirements for enteral nutrition pumps, infusion pumps, infusion pumps for ambulatory use, syringe or container pumps, volumetric infusion controllers and volumetric infusion pumps. This particular standard does not apply to the following: devices specifically intended for diagnostic or similar use; devices for extracorporeal circulation of blood; implantable devices; equipment specifically intended for diagnostic use within urodynamics; equipment specifically intended for diagnostic use within male impotence testing; and devices covered by ISO 28620. This second edition cancels and replaces the first edition of IEC 60601-2-24. This edition constitutes a technical revision according to IEC 60601-1:2005+A1:2012 with new clause numbering, including usability and alarms.

Committee
CLC/TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current

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EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
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
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IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
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