What is the IEC 60601 1 standard?

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 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 are the main types of standards?

Following are different types of standards:

  • Basic standards.
  • Normal standards.
  • Current standards.
  • Attainable (expected) standards.
  • Ideal (theoretical) standards.

What is IEC code?

An Importer -Exporter Code (IEC) is a key business identification number which mandatory for export from India or Import to India. No export or import shall be made by any person without obtaining an IEC unless specifically exempted.

Is IEC different from ISO?

The scope of ISO covers standardization in all fields except electrical and electronic engineering standards, which are the responsibility of the International Electrotechnical Commission (IEC). The work in the field of information technology is carried out by a joint ISO/IEC technical committee (JTC 1).

What is the new philosophy of IEC 60601-1?

The 3rd Edition of IEC 60601-1 represents a shift in philosophy from the 2nd Edition, including a greater emphasis on risk management and essential performance. As with any other standard change, a failure to implement these new requirements in a timely manner could cause costly delays in getting your device to market.

When is IEC 60601 merged to Medical Device Directive 93 / 42?

IEC 60601-1 merged to medical device directive 93/42/EEC which covers all IEC standard of electromedical & electrical safety so it is clear that EC cover all Previous IEC standard to medical device directive 93/42/EEC The mandatory date for implementation of the EN European version of the standard is June 1, 2012.

Why is IEC 60601 important for medical equipment?

60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many countries. Many companies view compliance with IEC 60601-1 as a requirement for most markets. This standard does not assure effectiveness of a medical device.

What is the IEC 60601-1 network isolator standard?

The IEC 60601-1 standard requires that two independent precautionary measures (Means of Patient Protection, or MOPPs) are set in place, to protect the patient from electrical shock in the medical system. A network isolator can be constructed to provide one or both required MOPPs.