Your new and existing medical devices must demonstrate compliance with the latest revision of iec 60601. The iec 606011 standard defines electromedical products as equipment provided with no more than one connection to a particular supply mains and intended to diagnose, treat or monitor the patient under medical supervision, and which makes physical or electrical contact with the patient andor transfers energy to or from the patient andor detects such energy transfer to or from the patient. Full 606011 compliance and agency listing, surge protection, integrated locking safety covers and a 15 ft. Iec 60601 is a widely accepted series of international standards for the basic safety and essential performance of medical electrical equipment. Mecamedical equipment compliance iec 606011 franklin. Most products covered under the scope of ul 544 and ul 187 have been reevaluated to comply with standard ul 606011.
Iec 60601110 closed loop controllers issued in 2007 iec 60601111 home health care issued in 2010 iec 6060121 electron accelerators issued in 2009 iec 6060122 high frequency surgical equipment issued in 2009 general standard part 1 standard iec 606011 collateral standards iec 606011xx 6060112 606011 3 606011xx 6060121 606012. We are accredited to iso 17025, are a certified body testing laboratory cbtl under the iecee cb scheme and participate in the ul data acceptance program dap, intertek recognized. Back to standard 610101, edition 3 the cost to purchase this standard varies depending on whether you are ordering a hardcopy, pdf or combination of the two. Outline of investigation for pump tank extinguishers. Electromagnetic compatibility iec 6060112, biocompatibility iso 109931. Iec 606011 medical electrical equipment part 1 tdklambda emea. Ul 606011 usa medical device design for iec 606011. Although this standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety. All indications of passfail in this report are opinions expressed by ul verification services inc. Aug 07, 2018 iec 606011 third edition amendment 1 ed. Page 1 certificate of compliance certificate number 20180817e356265 report reference e356265d10541a0c0ul issue date 20180817 issued to.
In order to more closely align the ul standard number with the iec standard number, ul published the first edition of ul 606011 in april 2003 to replace ul 26011. In 2005, the third edition of iec 606011 was published. Ul 1778 uninterruptible power systems standards catalog. Iec 606011 medical design standards for power supplies cui inc. This document cancels and replaces the first edition of iec 606011 3, published in 1994 which replaced iec 407 issued in 1973. The following are the main differences between ul 60601 1 and iec 60601 1. The cost to purchase this standard varies depending on whether you are ordering a hardcopy, pdf or combination of the two. 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 series of technical standards for the safety and essential performance of. General requirements for basic safety and essential performance collateral standard. Even in countries where compliance is not mandated by regulations e. The medical device developers guide to iec 606011 601help. Changes from 2nd to 3rd edition 3 of our clients are continuing to use the 2nd edition. Although some regulatory bodies have already started implementing iec 606011 edition 3. 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. Electromagnetic compatibility iec 6060112 or protection for diagnostic use of xrays iec 606011 3.
Safety requirements for electrical equipment for measurement, control, and laboratory use part 1. Iec harmonized standard ul 606011 became effective. Ul 606011 edition 1 revision date 20060426 csa c22. European union cemark the 3rd edition has been published as. Complete document medical electrical equipment part 1.
Konformitatsbericht iec 606011 3rd edition bayoomed. Meca iec 60601 iso 80601 medical standards list rev 20181117c. In the iec 601 series, collateral standards specify general requirements for safety applicable to. Product safety standards for medical devices intertek. Approved for standalone use in all patientcare vicinities. As shown in the diagram below, when corrigendum 1 and 2, and amendment 1 are applied to edition 3, the resulting document is the same as edition 3. Electrical rigid metal conduit aluminum, red brass, and stainless steel. The 3rd edition of iec 606011 iec 606011, 2005, along with its national deviations, is one such standard. While the original iec 606011 standard has existed now for 40 years, technology has evolved and the environments where medical equipment is used has grown more complex. General requirements for basic safety and essential performance the product was not investigated to the following standards or clauses. We also offer two different types of subscriptions.
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 underlying premise of iec 606011 is understanding and managing risk, which the 3 rd edition developed by defining electrical performance requirements for safe operation in terms of the means of protection for both patients and operators. This report consists of the following report types. Differing regions, differing status some countries have published national standards in line with iec 606011 edition 3. To keep pace with technological change, the standard has also evolved over time, and currently, equipment needs to comply with edition 3.
General requirements for basic safety and essential performance includes all. Standard for surface raceways and fittings for use with data, signal, and control circuits. Jul 19, 2016 additionally, compliance with edition 3. If you are unsure as to which version to use, contact your intertek account manager or project engineer. This collateral standard to iec 606011 specifies general requirements and tests for basic safety. General requirements includes all amendments and changes through revision pages, july 19, 2019 view abstract. General requirements for basic safety and essential performance. Pipeline systems for compressed medical gases and vacuum. Ul 610101 safety requirements for electrical equipment.
January 2017 safety requirements for electrical equipment for measurement, control, and laboratory use part 1. Meca provides highquality testing and documentation necessary to show compliance with medical and laboratory equipment standards, primarily related to the iec 606011 and iec 610101 series of standards. We are accredited to iso 17025, are a certified body testing laboratory cbtl under the iecee cb scheme and participate in the ul data. Any information and documentation involving ul mark services are provided on behalf of ul llc ul or any authorized licensee of ul. While the application of risk management principles have been clarified, the amended standard includes new. There is often confusion regarding the differences between iec 606011 ed 3, and iec 606011 ed 3.
By the way, committee sc62a the author of iec 606011 ed. The fourth edition iecen 6060112 4th edition will become a. Conclusion iec 623661 describes a usability engineering process that is comprehensive and requires the investment of considerable resources and time, but is regarded to be an excellent means. Intertek can help your medical devices comply with ul 60601. A systems approach to medical device compliance with iec. The iec 60601 standard has a long history with a number of revisions. Iec 606011 ist fur aktive medizinprodukte pems mit anwendungsteil anzuwenden. I have an existing product with no safety issues or field problems for 10 years. Compiled by our safety experts around the globe, this white paper provides a summary of the new and revised requirements of iec 606011 edition 3. The following are the main differences between ul 606011 and iec 606011. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding. Compliance will be determined by the requirements located in cancsac22. Electromagnetic disturbances requirements and tests.
Note 1 this interpretation sheet is intended to be used with both edition 3. Meca provides highquality testing and documentation necessary to show compliance with medical and laboratory equipment standards, primarily related to the iec 60601 1 and iec 61010 1 series of standards. This edition has been restructured and aligned to iec 6060112005 and focussed on general requirements for. European union cemark the 3rd edition has been published as an en standard. Requirements of 606011 may be overridden or bypassed by specific language in the standards for a particular product.
Ul standard for safety electrical equipment for measurement, control, and laboratory use. All nonmedical equipment and personal devices are required to be plugged directly into the wall within the patientcare vicinity. Ul authorizes the applicant to reproduce the latest pages of the referenced test report consisting of the first page of the specific technical criteria through to the end of the conditions of acceptability. Ul 610101 safety requirements for electrical equipment for. The cost to purchase this standard varies depending on whether you are ordering a. Top 5 faqs when choosing healthcare power products. In order to more closely align the ul standard number with the iec standard number, ul published the first edition of ul 60601 1 in april 2003 to replace ul 2601 1. Principally this determined isolation, creepage and insulation specifications for different classes of use. Iec 606011 amendment only corrigendum 1, december 12.
General requirements for basic safety and essential performance collateral. This standard applies to the safety of medical electrical equipment as defined in subclause 2. This group safety publication is primarily intended to be used as a product safety standard for the products mentioned in the scope, but shall also be used by technical committees in the preparation of their publications for products similar to those mentioned in the scope of this standard, in accordance with the principles laid. Similarly, it is expected that these recommendations within iec 6060143 will be considered when preparing future revisions of iec 606011 and related. Only medical and diagnostic equipment is to be plugged into a ul 606011 compliant power strip or surge protector within the patientcare vicinity. Your new and existing medical devices must demonstrate compliance with the latest revision. Other collateral standards include 606011 3, covering radiation protection for diagnostic xray systems, 6060119 relating to environmental design, and 60601111 recently introduced for home healthcare equipment. Iec 606011 does not apply to medical gas pipeline systems covered by iso 73961, medical gas pipeline systems part 1. Collateral standards numbered 606011x define the requirements for certain aspects of safety and performance, e. General requirements includes all amendments and changes through revision. The motivation for these exclusions was the fact that the scope of iec 606011 is that of a type examination standard.
1502 132 430 998 1097 216 581 548 210 1397 765 682 672 1276 259 1474 1093 1053 327 873 974 961 423 551 927 672 795 340 594 174 29 1404