EN 60601-2-24

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Logo of the German Institute for Standardization DIN EN 60601-2-24
Area Medical technology
title Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and infusion regulators
Latest edition 2.1999
ISO IEC 60601-2-24: 1998

The EN 60601-2-24 titled "Electrical Medical devices - Part 2-24: Particular requirements for the safety of infusion pumps and controllers" is part of the series of standards EN 60601 .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-24 .

The standard is based on the international version IEC 60601-2-24. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-24 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for the safety, tests and guidelines of infusion pumps and infusion regulators.

validity

The German edition 2.1999 has been accepted as a German standard from the date of its publication .

  • The current version (2.1999) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
  • A draft for use with the 3rd edition of DIN EN 60601-1 was published in September 2009.

scope of application

These special provisions specify requirements for the safety of infusion pumps, infusion regulators, syringe pumps and infusion pumps for outpatient applications. These products are intended for use by medical staff and home patients under medical supervision.

The standard does not apply to the following areas:

  • special application for diagnostic and similar purposes (e.g. angiography or other pumps that are under constant supervision by the user);
  • enteral feeding ;
  • extracorporeal circulation of blood;
  • Implants or disposable products;
  • Devices for diagnostic use during urological examinations (measurements of the pressure / volume ratio while the urinary bladder is filled with water via a catheter);
  • Devices for diagnostic use during examinations of male impotence (measurements of the amount of infused fluid that is necessary to generate a specified pressure level for triggering a penile erection : cavernosometry, cavernosography).

extra information

The following changed requirements are contained in EN 60601-2-24 (excerpt):