An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the iec 6060112 standard approaches. In 2005, the third edition of iec 60601 1 was published. Bs en 6060112 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems. En 60601 was harmonized in the official journal of the european union in 2008 iec 60601 added amendment 1, also known as version 3. En 60601 or iec 60601 is the european harmonized standard to meet the medical device directive.
It constitutes a collateral standard to iec 606011. There are no new hazards presented with the use of the suture cutter as compared with predicate devices. En 606011 3rd edition electrical standard now harmonized. Particular requirements for the basic safety and essential performance of. Electromagnetic compatibility testing in accordance with en 6060112 was successfully performed. Page 1 of 163 report no trs11120147 test report en 606011. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. However in december 2018, newly certified or recertified medical devices will be required to meet the more rigorous requirements from the 4th edition. This edition has been restructured and aligned to iec 6060112005 and focussed on general requirements for radiation protection that apply to all diagnostic xray equipment. New bs en 606011 edition includes amendment 1 document. International standard iec 6060114 has been prepared by iec technical committee 62.
En 60601 medical electrical equipment and systems bsi. The new edition includes the 2006 revision plus the 3 corrigenda 122006, 122007 and 32010 and a new amendment 1 dated 123120. The fourth edition iec en 60601 12 4th edition will become a mandatory standard covering safety for medical devices on december 31, 2018. General requirements for safety, hereinafter referred to as the general standard. En 60601 is a family of standards whose scope covers the safety, essential performance and electromagnetic compatibility of medical electrical equipment and systems. It is technically equivalent to the international standard iec 60601 and the family comprises over 70 separate standards.
New medical emc standard iec 6060112 4th edition globtek. Understanding the major technical revisions to medical emc standard iecen 6060112. Bs en 606011 for medical electrical equipment has just been updated. While this standard is broadly considered all encompassing, it is important to note that in addition to. This part is a collateral standard and its objective is to outline requirements that are in addition to those of the general standard. This collateral standard to iec 606011 specifies general requirements and tests for basic safety. General requirements for basic safety and essential performance superseding asnzs 3200. En 606011 applies to all medical electrical equipment and medical electrical systems. While 606011 is the basic general standard, particular standards branch off into specific devices, such as high frequency surgical, endoscopic equipment, and infant incubators. Iec 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the international electrotechnical commission. Arthroscopy and sports medicine karl storz endoskope.
Iec en 606011s purpose is to control all aspects of safety directly related to the handling, use or connection to, electrical medical devices. Iec 606011 medical design standards for power supplies. En 60601 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. Although emission and immunity tests for medical products are very similar to those applied to. Common aspects of electrical equipment used in medical practice, of iec technical committee 62. Amendment dated 31 may 2011 implementation of iec corrigenda december 2006 and december 2007 tagged and implementation of cenelec corrigendum march 2010. 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.
Iec 60601 is a widely accepted series of international standards for the basic safety and essential performance of medical electrical equipment. Medical electrical equipment is defined in the standard as electrical equipment having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is provided with not more than one connection to a particular supply mains. Manufacturers developing and marketing medical devices have a staggering number of regulations, guidances, and industry standards to master. Therefore, most medical equipment manufacturers are opting for doing emc evaluations to the 4th edition at the current time. The date of cessation of presumption of conformity of the. En 606011 issues final draft for nbmed comments v1. Changes from 2nd to 3rd edition 3 of our clients are continuing to use the 2nd edition.
Other collateral standards include 60601, covering radiation protection for diagnostic xray systems, 6060119 relating to environmental design, and 60601111 recently introduced for home healthcare equipment. European union cemark the 3rd edition has been published as. Iec 606011 is the basis for the whole series of collateral and particular iec standards. It is a collateral standard its objective is to specify requirements that are in addition to those of the general standard. Bs en 60601 12 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems. Understanding the major technical revisions of iecen. Hazard analysis evaluations were also performed for the suture remover.
After that date, they will only recognize docs which show testing according to the iec 6060112 edition 4. Iec 60601 added amendment 1, also known as version 3. Iec en 6060112 has wording that addresses the use of radios in a medical device. Iecen 606011 medical device safety testing eurofins york. This document cancels and replaces the first edition of iec 60601, published in 1994 which replaced iec 60407 issued in 1973. Eurofins york updates its ukas accreditation to include testing to the general safety standard iecen 606011, for medical electrical equipment. European union eu the latest edition is now listed in the eu official journal as en 6060112. This first edition constitutes a collateral standard to iec 606011. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Statement regarding use of iec 606011 medical electrical. Bs en 60601110 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems. General requirements for basic safety and essential performance collateral standard. The european en and canadian csa versions of the standard are identical to the iec standard.
If you are unsure as to which version to use, contact your intertek account manager or project engineer. En 606011 3rd edition electrical standard now harmonized in. 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. Your new and existing medical devices must demonstrate compliance with the latest revision of iec 60601. General requirements for safety report reference no. An exemption for the main transmit signal from the radiated emissions limits provided that they meet the national requirements is given, but all other emissions must meet the radiated emissions limits of iec en 6060112.