IEC 62353 PDF

April 9, 2020   |   by admin

IEC Standards for the Safety and. Efficacy of Medical Electrical Equipment . Introduction. It might, perhaps, be a little too self-evident to say that there is no. The new IEC standard for the in-service and post repair testing of electromedical devices introduces new requirements. These and their. STANDARD. IEC. CEI. NORME. INTERNATIONALE. First edition. Première édition. Medical electrical equipment –. Recurrent test and test after.

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In addition, this measurement is only taken in a single polarity and is similar to a dielectric test at mains potential using a current limited mains frequency supply.

Download Your Free Guide to IEC from Rigel Medical Today

IEC Ground Bond Test The ground bond test proves the integrity of the low-resistance connection between the ground conductor and any metal conductive parts, which may become live in fault situations with Class I medical devices. IEC You can find in-depth information on IECincluding in-service test requirements in this part of the free guide.

Live to Earth Voltage. This standard is not applicable to the assembly of ME systems.

This standard is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design. For more information, contact. Introduction This section talks about electrical current, the human body and how it conducts current, and IEC Body Model.

An Introduction to IEC – 24×7 Magazine

Leakage measurements achieved using the alternative method are kec repeatable and provide a good indication of deterioration in the dielectrics of the medical device under test. The open circuit voltage of the current source should not exceed 24V. As a result, there are stringent rules on the design of medical equipment to ensure that the patient and operator are not exposed to those currents that do not form part of the functional operation of the device.


Although visual inspection is not clearly lec in IECits inclusion is a fundamental requirement of all routine test and maintenance procedures. Preview Abstract IEC Acceptance testing, also referred to as uec or reference testing. Measurements can also be influenced by the presence of magnetic fields—the principle of measuring differential current—and measurements must be done in both directions to identify the worst-case scenario.

An Introduction to IEC 62353

Once a medical device enters into service, a number of potential test scenarios arise, including: As a type-testing standard, the current IEC does not provide any guidance to standardizing test requirements once an item of ME equipment has passed the design phase.

The aim of this booklet is to help the reader to: Ensure that iex operator of safety test equipment is properly trained on both the safety analyzer and the device under test to prevent unneccessary danger during the safety test. In the interests of helping to guarantee safer practice and the repeatability of test measurements, IEC defines different types of leakage current tests—one for total equipment leakage and another for applied parts 623553 currents.

The introduction of IEC is intended to streamline this 26353 and harmonize all standards that aim to control the safety of electromedical EM devices used in the treatment, care, and diagnosis of patients.

Published on September 7, While the first day of the U.

Housing enclosure—look for damage, cracks, etc; Contamination—look for obstruction of moving parts, connector pins, etc; Cabling supply, applied parts, etc —look for cuts, wrong connections, etc; Fuse rating—check correct values after replacement; Markings and labeling—check the integrity of safety markings; and Integrity of mechanical parts—check for any obstructions.

For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. Once a medical device enters into service, a number of potential test scenarios arise, including:.


The assumption was made that higher currents could best detect any damaged conductors present.

Ensure that leakage measurements are performed while the equipment is in full operation mode, including its subsystems and components. You can find a comprehensive overview of Insulation Resistance Test covering: By submitting your details you agree to our Privacy Policy. The differential test method measures the leakage current as a result of imbalance in current between the live and neutral conductors.

Appendix This contains reference tables for pass fail limits, standards, and documentation templates. Our prices are in Swiss francs CHF. It is often part of a service carried out by in-hospital mechanical or clinical engineering teams.

All maintenance, inspection, servicing, and repair done in accordance with the manufacturer’s instructions maintain the conformity to the standard used for the design of the equipment.

Free Guide to IEC 62353

Appreciate the basics of electrical safety. After service and repair testing—carried out following a repair, adaptation, or product upgrade. Earth Bond Testing Earth bond test considerations and precision vs accuracy are discussed in this section.

Acceptance testing is often not limited to electrical safety tests, with some basic function tests being applied to verify correct performance. The main advantage of using the alternative method included in IEC is that the device under test is not connected to the mains supply and provides the safest possible test conditions for the operator.