IEC 62353
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Passionate about patient safety.

Passionate about patient safety. Products in the Rigel Medical Range Accessories and Services from Rigel Medical Medical Electronic Equipment Visual Inspection Earth Bond Testing Insulation Resistance Test Record Keeping Appendix A: Pass/Fail Limits of IEC 62353 Appendix B: IEC 60601-1 Collateral Standards Features include: Appendix C: IEC 60601 Test Standards • Automatic testing with data storage capabilities Appendix D: Patient Environment Appendix E: Example Documentation Passionate about patient safety... ...accurate and fast, hand-held electrical safety analyzer. The Rigel 288+ is the...

Passionate about patient safety. Rigel Medical: Keeping medical industries safe World-leading biomedical test and measurement equipment At Rigel Medical, we’ve been a pioneer of biomedical test and measurement instruments for more than four decades. Since launching the world’s first IEC 601 electrical safety analyser in the 1970s, our user focused developments continue to place us at the forefront of the industry. Our comprehensive suite of electrical safety analysers, performance analysers and vital signs simulators enable biomedical and clinical engineers to confirm their adherence to a...

Passionate about patient safety. Introduction This guide covers a basic introduction to electrical safety, definitions of a medical electronic device, the IEC 60601 standard and an in depth overview of the IEC 62353 publication. The structure and topics discussed in this guide are written in a way such that the widest possible audience can benefit. Electrical Current Electrical current is a secondary energy form consisting of the flow of charge (in coulomb) through a circuit over a certain time period, and is depicted in ampere. When electrical current passes through a conductor or...

Passionate about patient safety. The Human Body A significant part of the human body is made up of water along with dissolved ions and minerals, which are capable of conducting electrical currents. Broadly speaking, the hazard of such electrical currents would depend on: ∙ ∙ ∙ ∙ ∙ Strength of the current Path of the current Total impedance for the current path Frequency of the current Duration of the current being applied Electrical currents can be extremely dangerous to the human body. The energy released by electrical current passing through human tissue can generate burns and excite or...

Passionate about patient safety. Heath facilities including hospitals, surgeries, GP practises, veterinarian clinics, and dentists use a variety of electrical equipment, ranging from, specialist medical, laboratory and IT equipment to ordinary domestic appliances. Voltage measuring instrumentb) Medical Electronic Equipment The main impedance is formed by a 1kΩ resistor, shown in Figure 4. IEC 60601 Body Model To ensure a standardised method of simulating the impedance of the human body, measurement circuits have been designed to simulate the average, typical electrical characteristics of...

Passionate about patient safety. Type B Applied Part - Applied part complying with specified requirements for protection against electric shock. Type B applied parts are those parts, which are usually earth referenced. Type B are those parts not suitable for direct cardiac application. Type BF Applied Part - F-Type applied part complying with a higher degree of protection against electric shock than type B applied parts. Type BF applied parts are those parts not suitable for direct cardiac application. Type CF Applied Part - F-Type applied part complying with the highest degree of...

Passionate about patient safety. DESIGN (IEC 60601) TYPE TEST (IEC 60601) OPERATOR TRAINING Product Lifecycle For many years, ME equipment has been subject to extensive approval processes from clinical trials, to type testing all the way through to end of production line testing, to ensure it operates properly before leaving the factory. In addition, manufacturers recommend that regular electrical safety and essential performance checks are carried out to ensure there’s no risk of harm to the patient and operator once the device goes into service. Design During this stage a concept is...

Passionate about patient safety. IEC 60601 ME equipment must meet the design requirements as set out by the IEC 60601 (a harmonised standard), which has been adopted by all IEC member states. This sets out all the design criteria for producing equipment that is electrically and mechanically safe, as well as placing the onus on the manufacturer to understand how to reduce the risk of harm when patient and operators are exposed to their medical devices. All tests relating to the electrical safety of ME equipment and devices can be categorised into two categories: ∙ Means of Operator...

Passionate about patient safety. Introduction to IEC 62353: 2014 As its full name implies, IEC 62353 Medical Electrical Equipment - recurrent test and test after repair of ME equipment defines the requirements for electrical safety testing of medical electrical (ME) equipment and systems during routine intervals. Following the need for a unified approach to routine testing, the first edition of IEC 62353 brought together a set number of tests to allow its users to test the MOOP and MOPP dielectric integrity via two distinct leakage current tests: ∙ Equipment Leakage - Testing the total...

Passionate about patient safety. Earth leakage Equipment leakage DIR/DIF Earth leakage SFC neutral Enclosure leakage SFC earth Equipment leakage DIR/DIF Patient leakage Equipment leakage (enclosure probe disconnected) Mains on applied parts Applied part leakage Measured values Only direct method Visual Inspection The process of visual inspection is not clearly defined by IEC 60601, however visual inspections form a critical part of the general safety inspections during the functional life of medical equipment. In most cases, 70% of all faults are detected during visual inspections. The...