Patient Care Swithing Power Supplies and UL/EN60601 3rd Edition

The third edition of IEC 60601-1 provides a major update of the IEC 60601 series of medical electrical equipment safety standards for medicalmedical approved power supplies and the systems they power. First released in 1977, IEC 60601-1 is as the handbook of medical electronics safety and the forerunner standard of over 60 different device standards which and the medical power supplies that power them.

An Analysis of the Changes

The evolvement toward the 3rd edition started before the last amendment was published in 1995. Formal work on the new revision began in early 1997 and took nearly nine years to complete. During the formation of developing the third edition, the purview of IEC 60601-1 was immensely changed and expanded. The first major updated came when the eternal argument within IEC Subcommittee 62A over what many considered an nonessential impediment in the definition of the standard was agreed upon, and the Subcommittee got rid of the phrase 'under medical supervision' from the definition of medical electrical equipment. This change resolved the debate abut whether or not equipment that complied with all the other definitions of medical electronic equipment, 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 good example. While such devices obviously meet all the other characteristics of medical electrical equipment, it can be definitively argued that these are not operated under medical supervision. Under the new defintions of the third edition, there is no question that AEDs are covered by IEC 60601-1.

The next big update occurred when Subcommittee 62A implemented a proposal from France to include 'or compensation or alleviation of disease, injury or disability' to the scope of medical electrical equipment. Previously, healthcare electrical systems was limited to devices 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 not apply to specific patient care devices. These systems are not specified in the scope of the ISO Committee dealing with aids for the disabled, unless the devices are meant for both domains of use. Many in the committee felt that excluding put a big hole in the standard's coverage. Many 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 series. Amendment 2 to the second edition included subclause 1.5, which described the kind of requirements that would be contained in a collateral standard and the relationship of the collaterals to the individual standards. Unfortunately, it was unclear with respect to whether or not medical electrical 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 discussed this issue and decided that, for the third edition, a collateral standard becomes a normative part of the primary standard on the date of its issuance. In effect, this procedure allows for an infinite number of amendments to include released general requirements to IEC 60601-1 because each new collateral standard becomes a normative part of IEC 60601-1 when released.

But, definitely the most striking evolvement in the third edition is the specification for the manufacturer of medical electronic equipment 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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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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