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. Manufacturers developing and marketing medical devices have a staggering number of regulations, guidances, and industry standards to master. They are in addition to the requirements of the general standard iec 60601 1 and serve as the basis for particular standards. This consolidated version of iec 60601 1 2 is based on the second edition 2001 documents. The 3rd edition of iec 60601 1 has not yet been adopted in china and no clear timetable exists. The test levels required by both the 2nd and 3rd editions of iec 60601 1 2 are the same. 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. Collateral and particular title status iec 6060111 medical systems incorporated cl. Complete document medical electrical equipment part 1. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding. This edition may have a significant impact on the design, testing and documentation of. Compliance is checked by measurement, taking into account annex f. The slower nature of the publication and adoption of the revised standard also led way to amendment 1, which mainly clarifies the original intent of edition 3. The primary change from 2nd to 3rd edition of iec 60601 1 is the expansion of two original tables into nine new tables on insulation identification.
Many customers ask when a new edition of iecen 606011 should be applied to reach approvals in different markets worldwide. 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. Iec 606011 medical design standards for power supplies cui inc. The third edition of iec 606011 was published in 2005. 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. Changes from 2nd to 3rd edition 1800worldlab 2 the status of the 3rd edition in major markets the adoption of the 3rd edition of iec 606011 has been slow since its release in december 2005. For example, a laser device used for the removal of. International standard iec 6060112 has been prepared by subcommittee 62a. This document cancels and replaces the second edition of iec 6060112, and. Iec 60601 is a series of technical standards that ensure the safety and effectiveness of medical electrical equipment.
Other collateral standards include 60601, covering radiation protection for diagnostic xray systems. General requirements for basic safety and essential performance. Iec 606011 compliance documents to evaluate medical electrical equipment to the applicable standards. Iec 606011 applies to all electrical and electronic medical devices and their accessories. General requirements for safety, amendment 1, amendment 2 and associated collateral standards see subclause 1. If a medical device is registered in japan and complies with iec. Changes from 2nd to 3rd edition 8 while the 3rd edition of iec 606011 now includes ep requirements, the manufacturers ep requirements may vary from the standards, depending on the proposed use of the. It is a collateral standard its objective is to specify requirements that are in addition to those of the general standard. Jul 19, 2016 iec 60601 1 is a lengthy, complex electrical safety standard. Given the size of the original standard and the complexity of the changes, implementing the changes can seem overwhelming. Iec 60601 is a series of technical standards that ensure the safety of medical electrical equipment. The 3rd edition is in the process of being adopted by global regulatory authorities. In this article, we detail the differences between these versions as well as provide information about the implementation dates in the us fda and eu european union. Amends the standard iec 60601219 to reflect iec 606011 2nd edition with its amendments 1 1991 and 2 1995.
Missing page numbers correspond to the frenchlanguage pages. For brevity, iec 606011 is referred to in this particular standard either as the general. We are accredited to iso 17025, are a certified body testing laboratory cbtl under the iecee cb scheme and participate in the ul data. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. 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. Collateral and particular title status iec 60601 1 1 medical systems incorporated cl. For example, references include iec 623 secondary cells and batteries, iec 62304 medical device software software lifecycle process, and others that are not addressed in depth in iec 606011. By the way, committee sc62a the author of iec 606011 ed. Iec 606011 includes many references to other standards that must be considered at an early stage.
Consolidated editions the iec is now publishing consolidated versions of its publications. However in december 2018 newly certified or recertified medical devices will be required to meet the more rigorous requirements from the 4th edition. This collateral standard to iec 606011 specifies general requirements and tests for basic safety. United states fda as of 17 october 2014, the fda included iec 6060112 edition 4. 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 iec 60601 1 2 committee released a revised version of this standard in 2014 edition 4 to replace the previous version from 2007 edition 3. As from 1 january 1997 all iec publications are issued with a designation in the 60000 series.
Changes from 2nd to 3rd edition 8 while the 3rd edition of iec 60601 1 now includes ep requirements, the manufacturers ep requirements may vary from the standards, depending on the proposed use of the device. Mecamedical equipment compliance iec 606011 franklin. It also includes information and interpretations for the clause requirements, as applicable. This fourth edition cancels and replaces the third edition of iec 60601 1 2, and constitutes a technical revision. Amends the standard iec 60601 219 to reflect iec 60601 1 2nd edition with its amendments 1 1991 and 2 1995. This means all other applicable collaterals and all other applicable clauses have to be included in the cb testing. The 3rd edition of iec 606011 has not yet been adopted in china and no clear timetable exists. After that date, they will only recognize docs which show testing according to the iec 6060112 edition 4. Aug 10, 2017 1 if a medical device is registered in japan and complies with iec. Each countrys testing agencies and regulatory bodies are.
Common aspects of electrical equipment used in medical practice, of iec technical committee 62. The evaluation package is a summary of the iec 60601 1. Lode is proud to announce that our products not only fulfill the requirements of the ul 60101 2nd edition but also the 3rd edition. Designing for compliance to iec 606011, 2nd edition and. General requirements for basic safety and essential performance collateral standard. The 606011 collateral standard for medical emc is 6060112, presently the 3rd edition of the standard is in force. Iec 6060112 is a collateral standard to iec 606011, which applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by medical electrical equipment and medical electrical systems. Iec 606011 is the basis for the whole series of collateral and particular iec standards. 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. The changes included a revision and renumbering of clauses to align it with the 2005 edition of iec 60601 1 and other iso iec editing requirements. Countries still mandating iec 606011 2nd edition include japan, australia, new zealand, and china. The 4 th edition is strictly one of these collateral standards known as, iec 6060112 electromagnetic disturbances. Third edition of iec 606011 3rd edition iec 60601 60601 third edition changes iec 60601 1 first edition 606011 edition 3.
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. This white paper provides a detailed overview of the fourth edition of iec 60601 1 2. The date of cessation of presumption of conformity of the. Within iec 606011, there are collateral standards that are denoted as iec 606011x. The new iec 60601 1 2 collateral standard describes this as, the basic safety and essential performance of medical equipment and systems in the presence of electromagnetic disturbances and.
International standard iec 60601 1 2 has been prepared by subcommittee 62a. But on a national level, regulatory affectivity dates are. Changes from 2nd to 3rd edition 60601 second edition 60601 3rd edition deadline. The test levels required by both the 2nd and 3rd editions of iec 6060112 are the same. Iec 606011 medical design standards for power supplies. European union eu the latest edition is now listed in the eu official journal as en 6060112.
Iso 606011 3rd edition in japan the quality forum online. A vertical line in the margin shows where the base publication has been modified by. For example, iec 34 1 is now referred to as iec 60034 1. Despite the more complex table structure in 3rd edition, it does provide for a more liberal view for operator protection. Does using either 2nd or 3rd edition make any device less safe. General requirements for basic safety and essential performance gives general requirements of the series of standards. This consolidated version of iec 6060112 is based on the second edition 2001 documents. Download free iec 60601 3rd edition implementation date. This consolidated version of iec 60601 1 2 is based on the second edition 2001 documents 62a336fdis and 62a341rvd and its amendment 1 2004 documents 62a462fdis and 62a469rvd. Aug 07, 2018 iec 606011 third edition amendment 1 ed.
The general standard iec 60601 1 medical electrical equipment part 1. An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the iec 60601 1 2 standard approaches. Iec 606011 for medical electrical equipment tuv sud. Countries still mandating iec 60601 1 2nd edition include japan, australia, new zealand, and china. The main iec 606011 standard referred to in europe as en 606011 and in canada as csa 606011 is an umbrella for numerous subsidiary standards, variously known as collateral or particular standards. Changes from 2nd to 3rd edition 8 while the 3rd edition of iec 606011 now includes ep requirements, the manufacturers ep requirements may vary from the standards, depending on the proposed use of the device. This collateral standard to iec 60601 1 specifies general requirements and tests for basic safety. In this paper we will look at the iec 606011 medical standard and its impact on. Iec 60601 1 2 4th edition expands on the risk analysis approach developed previously by delving more deeply into what we might simply call emc concerns. At the time of publication, there were 94 national committee comments on the 2nd cdv and the fdis that were deferred to a future amendmentrevision. While the application of risk management principles have been clarified, the amended standard. This bundled threeday course will help you gain a thorough understanding of how to use iec 60601 1 and ul 60601 1 effectively along with the changes that will be brought about by the issuance of iec 60601 1, 3rd edition.