IEC 60601

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IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission. 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.

Contents

General standard

The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of 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. [ citation needed ] Many companies view compliance with IEC 60601-1 as a requirement for most markets. 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. [2]

National deviations of this series of standards exist which include country specific requirements; [3] [4] see e.g. UL or AAMI for US specifics. [5] [6]

The European EN and Canadian CSA versions of the standard are identical to the IEC standard.

Revisions

In 2005, the third edition of IEC 60601-1 was published. 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 country/area 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 93/42/EEC which covers all IEC standard of electromedical & electrical safety so it is clear that EC cover all Previous IEC standard to medical device directive 93/42/EEC

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. [9]

Collateral and particular standards

Requirements of 60601-1 may be overridden or bypassed by specific language in the standards for a particular product. Collateral standards (numbered 60601-1-X) define the requirements for certain aspects of safety and performance, e.g. Electromagnetic Disturbances (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). [7] [8] Collaterals and Particulars may have their own revisions which are different from the General Standard.

A list of the collateral and particular standards currently in force follows: (last updated 15 September 2016)

For example, IEC 60601-1-9 for Environmentally Conscious Design of Medical Electrical Equipment published July 2007 is a collateral standard to IEC 60601-1 and has been developed drawing on extensive practical experience at Philips Medical Systems and Siemens Healthineers. The Part 9 standard asks manufacturers of medical devices to consider the environmental impacts of their devices throughout the product's entire life cycle and to minimize these where possible. 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.

According to the recent publication of the US national version of the collateral standard for products intended for home use, ANSI/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. 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 ].

Critics

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. [10] [11]

See also

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References

  1. ↑ "Premarket Approval (PMA)". Center for Devices and Radiological Health. FDA. Retrieved 2018-02-09.
  2. ↑ "Premarket Notification 510(k)". Center for Devices and Radiological Health. FDA. Retrieved 2018-02-09.
  3. ↑ National Deviations to IEC 60601-1, MDDI.
  4. ↑ National Deviations to IEC60601-1, Eisner Safety Consultants.
  5. ↑ "60601-1" (PDF). Standards info net. UL. Archived from the original (PDF) on 2011-09-29. Retrieved 2011-11-10.
  6. ↑ "FDA Recognizes AAMI Version of Electrical Equipment Standard". AAMI (Press release). August 10, 2010. Archived from the original on 2010-09-17.
  7. 1 2 "FDA Formally Recognize IEC 60601-1, 3rd ed". Eisner Safety Consultants. Retrieved 2018-02-09.
  8. 1 2 Regulatory Strategies for the Third Edition of IEC 60601-1, MDDI. Retrieved 6 September 2010
  9. ↑ IEC 60601-1-11:2015 redline version, IEC CH.
  10. ↑ Op Ed: The 60601-1 Third Edition Is Not Mandatory, MDDI.
  11. ↑ How Scary Is IEC 60601-1?, Medical electronics design.
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