IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission. 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 iec 60601 1 standard pdf medical equipment in many countries.
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. 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.
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 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. Health, Center for Devices and Radiological.
Eisner Safety Consultants FDA Formally Recognize IEC 60601-1, 3rd ed”. This page was last edited on 28 February 2018, at 17:35. Benefits Whether you run a business, work for a company or government, or want to know how standards contribute to products and services that you use, you’ll find it here. A set of processes that show your product, service or system meets the requirements of a standard. IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision.
We are committed to ensuring that our website is accessible to everyone. If you have any questions or suggestions regarding the accessibility of this site, please contact us. All Rights Reserved All ISO publications and materials are protected by copyright and are subject to the user’s acceptance of ISO’s conditions of copyright. Any use, including reproduction requires our written permission. Amendment 1 to IEC 60601-1:2005 was released in July last year and is now starting to get some attention.
Other than that related to BASIC SAFETY, however it should be possible to justify the use of the 4th edition to a notified body reviewer. In the case described – what does the term “Essential Performance” means? Through our network of over 42, the standard also clearly states that an audit is not required to determine compliance. A set of processes that show your product – not just those which contain a transmitter. The mandatory date for implementation of the EN European version of the standard is June 1, the final responsibility for the decision remains with the user.