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The following article was published in our article directory on February 3, 2011.
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Article Category: Computers and Technology
Author Name: Bob Viera
The recent third edition of IEC 60601-1 represents a drastic change of the IEC 60601 group of medical electrical equipment safety standards for medicalmedical approved power supplies and the equipment they power. First released in 1977, IEC 60601-1 is recognized as as the authority of medical systems safety and the forerunner standard of over 60 different device standards which and the medical power supplies that power them.
A Survey of the Changes
The evolvement toward the third edition started before the last amendment was issued in 1995. Formal work on the project began in early 1997 and has taken nearly nine years to finalize. During the progession of writing the third edition, the breadth of IEC 60601-1 was drastically updated and expanded. The first major change came when the ever-lasting disagreement within IEC Subcommittee 62A over what some considered an irrelevant impediment in the scope of the standard was resolved, and the Subcommittee removed the phrase 'under medical supervision' from the definition of medical electrical equipment. This change closed the dispute over whether or not electronics that satisfied all the other requirements of medical electronic systems, but was not intended for utilization by or under the close supervision of a trained professional, should be defined by the requirements of IEC 60601-1. The automatic external defibrillator (AED) now so common in airports and other public spaces is a typical example. While such devices clearly meet all the other specifications of medical electronic devices, it can be definitively seen that they are not designed for use under medical supervision. Under the new understanding of the third edition, there is no question that AEDs are covered by IEC 60601-1.
The next major update occurred when Subcommittee 62A adopted a proposal from France to include 'or compensation or alleviation of disease, injury or disability' to the scope of medical electrical equipment. Before, medical electrical systems was limited to systems intended by their manufacturer to 'diagnose, treat or monitor a patient'. The UK also stipulated that a stringent interpretation of the breadth of the second edition of IEC 60601-1 exclude various patient management devices. These equipment are not defined in the scope of the ISO Committee dealing with aids for the disabled, unless the systems are designed for both domains of use. Many in the community felt that taking out these devices left a large hole in the standard's coverage. Various of other standards, such as ISO 10535 for patient lifting equipment, refer to IEC 60601-1 for medical electronic systems and so for IEC 60601-1 to exclude this equipment is a contradiction.
Another disagreement that was broadly debated during the development of the third edition was the relationship of the additional standards in the IEC 60601 family. Amendment 2 to the second edition added subclause 1.5, which defined the kind of requirements that would be contained in a related standard and the relationship of the collaterals to the particular standards. However, it was unclear with respect to whether or not healthcare electronic systems must meet with any relevant collateral before it could be designated to comply with IEC 60601-1. Arguments on the question seemed fairly evenly divided. In 2003, Subcommittee 62A formally reviewed this question and decided that, for the third edition, a collateral standard becomes a normative part of the main standard on the date of its issuance. In effect, this process enables for an unlimited versions of amendments to add released general specifications to IEC 60601-1 because these published collateral standard becomes a normative part of IEC 60601-1 when adopted.
However, easily the most striking change in the third edition is the specification for the manufacturer of healthcare electrical devices to have a formal risk management system in place or risk non-compliance with the third edition of IEC 60601-1.
Read more: Medical; power Supplies and IEC 60601-1 – 3rd Edition / Third Edition http://advancedpowersolutions.com/medical-approved-power-supplies.html
Keywords: medical power supplies
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