What IEC 62353?
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.
What is the purpose of IEC 61508?
IEC 61508 allows for the development of a uniform technical policy that can be applied for all safety systems that are electrically-based. It is a horizontal standard applicable across a wide range of industry sectors. The standard requires the analysis of the potential risks or hazards of a given system or device.
What is IEC standard for medical devices?
IEC 60601 series is widely recognized as the basic safety and essential performance standard for medical electrical equipment. IEC 62366 has established a broadly recognized process model for achieving and validating optimal usability of devices.
What is the IEC 60601 1 standard?
IEC 60601-1 (Edition 3.1) deals with the basic safety and essential performance requirements of medical electrical equipment, and serves to ensure that no single electrical, mechanical or functional failure shall pose an unacceptable risk to patients and/or operators.
What is IEC compliance?
IEC stands for International Electrotechnical Commission. IEC testing brings together the agreed upon set of rules, specifications, and terminology that allow manufacturers to have their devices tested for conformity.
What is the maximum leakage current allowed in a medical device?
The widely accepted limit for touch current — the term newer standards use for leakage currents from the equipment case or enclosure of patient care medical equipment — is 500 μA.
Is IEC a 61508?
IEC 61508 is the international standard for electrical, electronic and programmable electronic safety related systems. It sets out the requirements for ensuring that systems are designed, implemented, operated and maintained to provide the required safety integrity level (SIL).
What is SIL2?
SIL2 – Low statistical risk of failure that you do not know about in the product. SIL3 – Redundant measurement capability – one of the primary differentiators between SIL2 and SIL3. SIL4 – Very few instruments available on the market, and extremely harsh demands to be certified for this.
What is iec62368?
IEC 62368-1 (UL 62368-1 and CSA 62368-1) merges IEC 60065, the electrical safety standard for audio, video and similar equipment, and IEC 60950-1, the standard for electrical equipment for information processing, office machinery and telecom equipment.
How do I get IEC certified?
Steps Involved in IEC (Import/Export Code) Registration
- Step 1: Application Form. First, you need to prepare an application form in the specified format – Aayaat Niryaat Form ANF-2A format and file it with the respective Regional office of DGFT.
- Step 2: Documents.
- Step 3: Filing Application.
- Step 4: IEC Code.
What is an IEC test report?
About IEC publications A Test Report Form (TRF) is a document prepared by a National Certification Body (NCB) allowing a test laboratory to record the evidences and the results of the tests and analysis made on a product. Its primary intent is to support the emission of a Certification Body Certificate.
Why is IEC 62353 important for medical devices?
The introduction of IEC 62353, Medical Electrical Equipment, Recurrent Test and Test After Repair of Medical Electrical Equipment, seeks to streamline this situation and harmonise all standards that specify measures to ensure the safety of electromedical devices used in the diagnosis and treatment of patients.
Which is a specific interpretation of IEC 61508?
Rail software. IEC 62279 provides a specific interpretation of IEC 61508 for railway applications. It is intended to cover the development of software for railway control and protection including communications, signaling and processing systems.
What are the requirements for IEC 61513 power plant?
IEC 61513 provides requirements and recommendations for the instrumentation and control for systems important to safety of power plants. It indicates the general requirements for systems that contain conventional hardwired equipment, computer-based equipment or a combination of both types of equipment.
What is the IEC 60601 medical electronic device?
1 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.