First published in basic electrical terms pdf and regularly updated and restructured, as of 2011 it consists of a general standard, about 10 collateral standards, and about 60 particular standards. 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. The European EN and Canadian CSA versions of the standard are identical to the IEC standard. In 2005, the third edition of IEC 60601-1 was published. Some key changes are: the outline and the numbering scheme of the clauses and subclauses were changed, risk management was made much more relevant and the concept of essential performance was added. IEC 60601 3rd edition series. The mandatory date for implementation of the EN European version of the standard is June 1, 2012.
The US FDA requires the use of the standard on June 30, 2013, while Health Canada recently extended the required date from June 2012 to April 2013. The North American agencies will only require these standards for new device submissions, while the EU will take the more severe approach of requiring all applicable devices being placed on the market to consider the home healthcare standard. Requirements of 60601-1 may be overridden or bypassed by specific language in the standards for a particular product. Collaterals and Particulars may have their own revisions which are different from the General Standard. The standard also requires that the manufacturer provide information to the user on how to use the product in the most environmentally sensitive way.
60601-1, but the national versions published to date do contain the requirement to also conform with IEC 60601-1-9. IEC 60601-1-9 collateral standard by September 2009. AAMI HA60601-1-11, the application of the standard does not apply to the nursing home environment. In the United States, nursing facilities are considered to be environments providing professional healthcare.
Devices typically mandated to use the new standard include oxygen concentrators, body-worn nerve and muscle stimulators, beds, sleep apnea monitors, and associated battery chargers prescribed for use at home. The 60601 certification process has been criticized for its complexity, cost, and the business risk it raises. This has been more particularly a concern during the transition to the third edition due to the indefinite adoption schedule of the new revision. How Scary Is IEC 60601-1? This page was last edited on 28 December 2017, at 16:45. Special types of network analyzers can also cover lower frequency ranges down to 1 Hz. A VNA is a form of RF network analyzer widely used for RF design applications.