Passionate about patient safety.

Passionate about patient safety. Local Adaptation Commonly Used Definitions within IEC 60601 Products in the Rigel Medical Range Accessories and Services from Rigel Medical Visual Inspection Earth Bond (Protective Earth) Testing Leakage Measurements Single Fault Condition Earth Leakage Test Enclosure Leakage Test Patient Leakage Patient Leakage F-Type Patient Auxiliary Current Record Keeping © Copyright 2021 - All rights reserved. Nothing from this edition may be multiplied, or made public in any form or manner, either electronically, mechanically, by photocopying, recording, or in any manner,...

Passionate about patient safety. Rigel Medical: We know about complying to IEC 60601-1. After reading this booklet, so will you. At Rigel Medical, we’ve been a pioneer of biomedical test and measurement instruments for more than four decades. Our comprehensive suite of electrical safety analysers enable biomedical and clinical engineers to confirm their adherence to a series of industry standards, manufacturers’ specifications and most importantly, keep patients, visitors, and staff safe in a healthcare environment. Since launching the world’s first IEC 601 electrical safety analyser in the 1970s,...

Passionate about patient safety. Introduction to IEC 60601 Not all people will understand the dangers associated with the exposure to electricity. It is this danger that has triggered several discussions relating to the safety of all members of the public. Regulatory bodies worldwide have acknowledged the dangers of electricity by producing legislation, standards and/or guidelines to control the design of electrical appliances in order to prevent any hazard to the general public. One environment where electric currents pose an acute threat is in the medical treatment and care of patients. Often,...

Passionate about patient safety. Commonly Used Definitions within IEC 60601 Equipment Under Test (EUT) The equipment which is the subject of testing. Device Under Test (DUT) The device which is the subject of testing. Applied Part Part of the medical equipment which is designed to, or likely to, come into physical contact with the patient. Patient Connection Individual physical connections and/or metal parts intended for connection with the patient which form (part of) an applied part. Patient Environment Volumetric area in which a patient can come into contact with medical equipment or contact...

Passionate about patient safety. Symbols and Markings The IEC 60601 has defined the requirements for information/data to be present on the medical equipment’s nameplate, in order to form an unambiguous identification of the equipment. Information must include specific manufacturer and equipment information, including manufacturer’s name, model number, serial number, and electrical requirements. Visual Inspection The IEC 60601 standard refers to a large variety of symbols for use on medical equipment, medical systems, accessories and other related parts. A full overview of the symbols used in...

Passionate about patient safety. Earth Bond (Protective Earth) Testing Leakage Measurements Earth bond testing, also referred to as ground bond testing, earth resistance, earth continuity or protective earth testing, tests the integrity of the low resistance connection between the earth conductor and any metal conductive parts, which may become live in case of a fault on Class I medical devices. Faults in the detachable power cord account for 80-90% of all Earth bond failures, as most moulded power cables are prone to stress when the cables are dropped. It takes only a small amount of current...

Passionate about patient safety. Applied part or patient leakage is the most important part of leakage measurement on any medical device. Applied parts are directly in contact with the patient or, in the case of invasive devices, placed under the patient’s skin. Currents applied under the skin, which forms our natural protection against electrical currents, can result in far greater consequences, with currents as low as 15 μA resulting in fatality. The limits for leakage currents within the IEC 60601-1 requirements are set to minimising the probability of ventricular fibrillation to a factor...

Passionate about patient safety. Earth Leakage Test Enclosure Leakage Test The earth leakage test shows the current flowing through the medical device or its insulation into the protective earth conductor. The earth leakage test is important as it demonstrates the total leakage from the EUT/ DUT. IEC 60601-1 specifies that the measurements are done under normal and reverse operation and single fault condition (neutral open circuit). The earth leakage test is valid for Class I equipment with Type B, Type BF and Type CF applied parts. Appendix A shows the pass/ fail limits as per IEC 60601-1 requirements....

Passionate about patient safety. Patient Leakage Patient Leakage: F-Type The patient leakage current is the current flowing from the applied part via the patient to earth, or flowing from the patient via an applied part to earth originating from an unintended voltage appearing on an external source. IEC 60601-1 specifies that the measurements must be done under normal and reverse operation of the mains supply and single fault conditions open neutral circuit and open earth. The patient leakage test is valid for both Class I and Class II equipment with Type B, Type BF and Type CF applied. Appendix...

Passionate about patient safety. Patient Auxiliary Current The patient auxiliary current displays the leakage current that would flow between applied parts under normal and fault conditions. For these tests, current is measured between a single part of the applied part and all other applied parts connected together. This test should be repeated until all combinations have been tested. This is also referred to as applied part to all. IEC 60601-1 specifies that the measurements be carried out under normal and reverse operation of the mains supply and single fault conditions open neutral circuit...