Iec 60601 1 Standard How To Use The

First published in 1977 and regularly updated and restructured, as of 2011 it consists of a general standard, about 10 collateral standards, and about 80 particular standards.

This standard does not assure effectiveness of a medical device.

In the US, evidence of effectiveness is required by the FDA and confirmed through either a Premarket Approval (PMA) 1 or similarity to a predicate device via a 510(k) Premarket Notification.

It was the result of a comprehensive review of the second edition (dating from 1988).

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.

Currently (2012), the applicability of the second and third edition is somewhat overlapping 7 8 depending on the products under consideration and the countryarea of application.

IEC 60601-1-11 (2010) must now be incorporated into the design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 60601 3rd edition series.

IEC 60601-1 merged to medical device directive 9342EEC which covers all IEC standard of electromedical electrical safety so it is clear that EC cover all Previous IEC standard to medical device directive 9342EEC.

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.

Collateral standards (numbered 60601-1-X) define the requirements for certain aspects of safety and performance, e.g.

Electromagnetic Compatibility (IEC 60601-1-2) or Protection for diagnostic use of X-rays (IEC 60601-1-3).

Particular standards (numbered 60601-2-X) define the requirements for specific products or specific measurements built into products, e.g.

MR scanners (IEC 60601-2-33) or Electroencephalograms (IEC 60601-2-26).

Collaterals and Particulars may have their own revisions which are different from the General Standard.

The Part 9 standard asks manufacturers of medical devices to consider the environmental impacts of their devices throughout the products entire life cycle and to minimize these where possible.

Iec 60601 1 Standard How To Use The

The standard also requires that the manufacturer provide information to the user on how to use the product in the most environmentally sensitive way.

The USA, Canada, Japan, Australia and New Zealand have not yet set transition dates for their national versions of this latest edition 60601-1, but the national versions published to date do contain the requirement to also conform with IEC 60601-1-9.

However, the European version (EN 60601-1:2006) requires compliance with the new IEC 60601-1-9 collateral standard by September 2009.

In the United States, nursing facilities are considered to be environments providing professional healthcare.

The American version of this collateral standard also places greater emphasis on a requirement that states that inspection of the usability engineering file reinforce that the usability engineering process is necessary for validation of the instructions for use.

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.

Although In Vitro Diagnostic devices such as blood glucose meters are being used by patients at home, the standard does not apply, as these devices remain under the jurisdiction of the more lenient IEC 61010 series citation needed.

This has been more particularly a concern during the transition to the third edition due to the indefinite adoption schedule of the new revision.

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