Patient Care Power Converters and UL60601 3rd Edition
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The third edition of IEC 60601-1 provides a modernization of the IEC 60601 series of medical electrical equipment safety standards for medicalmedical approved power supplies and the equipment they power. First published in 1977, IEC 60601-1 is known as the 'bible' of medical systems safety and the source standard of over 60 varying device standards which and the medical power supplies that power them.
An Outline of the Changes
The evolvement toward the third edition initiated before the most recent amendment was release in 1995. Efforts on the project began in early 1997 and took nearly nine years to complete. During the progession of developing the third edition, the scope of IEC 60601-1 was immensely changed and expanded. The first big change came when the long-standing debate within IEC Subcommittee 62A over what some considered an inessential impediment in the scope of the standard was agreed upon, and the Subcommittee deleted the phrase 'under medical supervision' from the definition of medical electrical equipment. This updated ended the debate over whether or not equipment that adhered to all the other requirements of medical electrical systems, but was not intended to be utilized by or under the close supervision of a trained professional, was within the scope of IEC 60601-1. The automatic external defibrillator (AED) now that are commonplace in airports and other public spaces is an excellent example. While such devices obviously fulfill all the other requirements of medical electronic devices, it can be definitively argued that these are not utilized under medical supervision. Under the revised defintions of the third edition, there is no question that AEDs are covered by IEC 60601-1.
The second big change happened when Subcommittee 62A implemented a request from France to include 'or compensation or alleviation of disease, injury or disability' to the scope of healthcare electrical equipment. Previously, healthcare electronic devices was related only to equipment intended by their manufacturer to 'diagnose, treat or monitor a patient'. The UK also made a case that a stringent interpretation of the breadth of the second edition of IEC 60601-1 not include various patient handling and support devices. These devices are not specified in the scope of the ISO Committee dealing with aids for the disabled, unless the devices are intended for both domains of use. Many in the community felt that excluding left a big hole in the standard's coverage. A number of other standards, such as ISO 10535 for patient lifting equipment, refer to IEC 60601-1 for medical electronic devices and so for IEC 60601-1 to exclude this equipment is a contradiction.
Another disagreement that was broadly debated during the writing 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 outlined the kind of requirements that would be contained in a related standard and the relationship of the collaterals to the individual standards. However, it was ambiguous with respect to whether or not healthcare electrical equipment must comply with any relevant collateral before it could be considered to comply with IEC 60601-1. Opinion on the question seemed fairly evenly divided. In 2003, Subcommittee 62A formally considered 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 release. In effect, this procedure enables for an infinite number of amendments to include published general requirements to IEC 60601-1 because all new collateral standard becomes a normative part of IEC 60601-1 when released.
But, plainly the most recognizable change in the third edition is the specification for the manufacturer of medical electrical systems to have a documented risk management system in place in order to comply 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 |
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Author Resource:-
Advanced Power Solutions offers Medical Power Supplies. ranging from 3 Watts to 500 Watts. APS medical power supply solutions can be modified to meet OEM requirements
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By :
Jessie Stone
Submitted
2011-02-04 18:48:48 |
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