In both the us and the eu by the end of 2018 application of the 4th edition of iec 6060112. 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. For these reasons, compliance deadlines to the 4th edition of iec 60601. Teguar blog why medical certification iec 606011 4th. This presentation touches on the challenges dealing with emc compliance on medical electrical equipment. Iec 606011 medical design standards for power supplies. The fda graciously extended the deadline for iec 6060112. An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the iec.
This is a summary of some of the changes in emc requirements of iec 60601 12, 4 th ed. General requirements for basic safety and essential performance collateral standard. The fourth edition iecen 6060112 4th edition will become a mandatory standard covering safety for medical devices on december 31. With the publication of the fourth edition of iec 60601 12 1 and its european equivalent, en 60601. Your medical device must comply with the 4th edition of iec 60601 12 by december 31, 2018, for europe, united states fda and canada. For those of you who managed to get your products cleared and on the market prior to the december 31, 2018.
Medical devices are you ready for the 4th edition of en. Iec 60601 12 4th edition emc nicholas abbondante chief engineer, emc. The global timeline for compliance with the various editions of iec 606011, including the 4th edition emc standards is fully detailed here. The 4 th edition is strictly one of these collateral standards known as, iec 6060112 electromagnetic disturbances requirements and tests, that has been extensively revised. The fourth edition iec en 6060112 4th edition will become a mandatory standard covering safety for medical devices on december 31, 2018. The fourth edition of this standard was published in 2014 and the transition date is fast approaching. New medical emc standard iec 60601 12 4th edition the 60601 1 collateral standard for medical emc is 60601 12, presently the 3rd edition of the standard is in force.
Instead, iec 6060112 4th edition considers immunity in terms of intended use environments and no longer includes the lifesupporting equipment category, a definition which led to. Intertek can guide you and help you understand standard iec 6060112 4th edition for medical devices with these frequently asked questions. The fourth edition of iec 6060112 to address emi threats of today use in areas outside the hospital wireless low frequency magnetic eas rfid other me patient cables hf surgical. The most significant changes with respect to the previous edition. Ray digs into the new edition and summarizes the differences you need to. Be prepared for the 4th edition of the iec 606011 medical. The purpose of this additional risk analysis is to determine appropriate levels of electromagnetic immunity, taking account of the equipments intended operating environment and. Changes for medical equipment iec 60601 1 march 27, 2017 ul 60601 1 and cancsa c22. For example, for a particular standard part 2 particular standards iec 60601 2xx or iec iso 806012xx for a given device will most likely at this time reference iec 60601 12, 4th edition if the country is using the most current iec 60601 2xx or iec iso 806012xx standard but otherwise may be referring to an older version of the iec 60601. Electromagnetic disturbances requirements and tests. To learn more, we asked lorenzo cividino, director, global applications and support at sl power electronics, a company that designs, makes, and markets power conversion solutions for a number of applications, including the medical industry, to tell us more about the latest edition. After that date, they will only recognize docs which show testing according to the iec 60601 12 edition 4. This fourth edition cancels and replaces the third edition of iec 6060112, and constitutes a technical revision.
In addition, the fourth edition of iec 60601 12 has just been published, and this. Medical devices are you ready for the 4th edition of en 60601 12. Emc has the potential to create problems that range anywhere from mild nuisance an alarm going off unnecessarily to potentially drastic device malfunction or stoppage. It now includes class 1c laser equipment, as defined in iec 608251. Understanding the central differences between the 3rd and 4th edition of iec 60601 12 medical device emc standard published on october 5, 2017 october 5, 2017 21. They are in addition to the requirements of the general standard iec 60601 1 and serve as the basis for particular standards. However, the united states fda prefers products to be evaluated to the 4th edition. Manufacturers developing and marketing medical devices have a staggering number of regulations, guidances, and industry standards to master. The 606011 collateral standard for medical emc is 6060112, presently the 3rd edition of the standard is in force.
The iec 606011 technical standards for medical electrical equipment are about to change and cui has power supplies available now to meet. One of the fundamental standards for medical device emc was written with significant input from the fda. General requirements for basic safety and essential. For this reason, while the test levels are the same, the objective of the testing and what is being monitored may be different in a 2nd and 3rd edition test report. Iec 6060112 4th edition for medical emc has immunity. Why medical certification iec 60601 1 4th edition matters. Healthcare environment home healthcare environment magnetic immunity 5060 hz 3 am. Testing emissions and immunity, 3rd to 4th comparison. In 2014, the international electro technical commission iec published a revision of the electromagnetic compatibility emc requirements for medical devices under a 4th edition of iec 6060112. The general standard iec 60601 is the accepted standard. Iec 60601 12 4 th edition is significantly different from its predecessor.
What is the impact of switching to iec 60601 12, 4 th edition. Iec 6060112 testing product certification services. Changes for medical equipment iec 606011 nts news center. Iec 6010112 4th edition was released in 2014 and will be required after. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. New medical emc standard iec 6060112 4th edition globtek. Get informed on the what, when, and where of the coming iec 4th edition medical standard, including its impact on power supplies and medical. They are in addition to the requirements of the general standard iec 606011 and serve as the basis for particular standards. Compliance with the 4th edition has been harmonized between the us, canada and europe and will apply from january 2019 with other countries undoubtedly to follow suit. Notice additional guidance on transition from the second.
The main iec 606011 standard referred to in europe as en 606011 and in canada as csa 606011 is an umbrella for. A new 4th edition has just been released for iec 60601 12, medical electrical equipment part 12. It was issued by the international electrotechnical commission iec. In other words, iec 6060112 4th edition addresses a reciprocal concern about emc affecting both the medical device in question and other devices in the vicinity. Why medical certification iec 60601 1 4th edition matters 12272017 2. Electromagnetic compatibility emc requirements for medical devices and systems is defined by iec 60601 12. New emc requirements per 4th edition of iec 6060112 in. From 2018, the amendment 1 to iec 60601 1 3rd edition applies for the production of electrical medical devices that are supposed to be marketed in the eu. One of the first things to understand is what this standard is and why is it a requirement for medically certified computers. Understanding the central differences between the 3rd and. There are a number of changes in the 4th edition, including new immunity and risk analysis. An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the iec 60601 12 standard approaches.
Currently, health canada recognizes both the second edition of iec 60601 1, published in 1988, and the third edition, published in 2005. In october, 2008, health canada published a notice indicating that until june 1, 2012, conformity to the second edition of iec 60601. European union eu the latest edition is now listed in the eu official journal as en 60601 12. New medical emc standard iec 6060112 4th edition the 606011 collateral standard for medical emc is 6060112, presently the 3rd edition of the standard is in force.
The main change was in clause 4, where 3rd edition recognizes that iec 606011. Iec 6060112 4th edition emc power sources manufacturers. The international electrotechnical commission introduced the fourth edition of iec 60601 12. The 606011 collateral standard for medical emc is 6060112, presently the 3rd. The fourth edition implementation of this emc standard is on the horizon and is a collateral standard to the iec 60601 1 medical safety standard. Products that are placed on the market after 31122018 must comply to en 6060112. The global timeline for compliance with the various editions of iec 60601 1, including the 4th edition. At the 2015 tc 62 meeting in kobe, japan, an ad hoc group was approved for the development of the architecture of the 4th edition of the iec 60601 series.
Eliminate shortcomings of the third edition outlines a comprehensive method for assuring emc of medical devices for alternative environments. As from the 30 th december 2018, the 3rd edition of the collateral standard for medical electrical me equipment, iec en 60601 12, will be repealed and compliance to 4 th edition of iec en 60601. This fourth edition cancels and replaces the third edition of iec 60601 12, and constitutes a technical revision. In both the us and the eu by the end of 2018 application of the 4th edition of iec 60601 12. This white paper provides a detailed overview of the fourth edition of iec 60601 12. Iec 60601 12 applies to the electromagnetic compatibility emc of electrical medical equipment. For this reason, while the test levels are the same, the objective of the testing and what is being monitored may be different in a 2nd and 3rd edition.
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