BS EN 60601-2-24:2015
Current
The latest, up-to-date edition.
Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers
Hardcopy , PDF
English
30-06-2015
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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 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
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT.
| Committee |
CH/62/4
|
| DevelopmentNote |
To be read in conjunction with BS EN 60601-1-2 & BS EN 60601-1. Supersedes 90/51556 DC. (11/2005) 1998 Edition along with its amendment remains active & will be Withdrawn on 14/04/2018. Supersedes 09/30178083 DC. Supersedes BS 5724-2.24(1998) & BS 5724-2.124(1998) which remains active & will be withdrawn on 14/04/2018. (08/2015)
|
| DocumentType |
Standard
|
| Pages |
68
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| UNE-EN 60601-2-24:1999 | Identical |
| I.S. EN 60601-2-24:2015 | Identical |
| DIN EN 60601-2-24 : 2016 | Identical |
| SN EN 60601-2-24 : 1998 | Identical |
| IEC 60601-2-24:2012 | Identical |
| EN 61925:2006 | Identical |
| NF EN 60601-2-24 : 2015 | Identical |
| EN 60601-2-24:2015 | Identical |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| EN 61000-4-2:2009 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| 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 |
| 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 |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| 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 |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| EN ISO 3696:1995 | Water for analytical laboratory use - Specification and test methods (ISO 3696:1987) |
| EN 60601-1-8:2007/A11:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
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