Iec 60601 1 6, usability, in determining what information must be presented. The third edition of iec 6060116 was published in 2010. General requirements for basic safety and essential performance collateral standard. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i. Although if focuses primarily on electromechanical devices, it also applies to aspects of the software components. Iec 606011 is the basis for the whole series of collateral and particular iec standards.
En 60601 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. The fourth edition iec en 60601 1 2 4th edition will become a mandatory standard covering safety for medical devices on december 31, 2018. Aug 07, 2018 iec 606011 third edition amendment 1 ed. Iso and iec standards for software in medical devices in a. Iec 6060116 iec 62366 usability engineering medteq. The fourth edition iecen 6060112 4th edition will become a mandatory standard covering safety for medical devices on december 31, 2018. Then iec 62304 shouldnt be mandatory and it should be possible to apply iec 606011 standard alone. The third edition created a bridge that enables a manufacturer to conform to the requirements in iec 60601 1 that make normative reference to iec 60601 1 6 by employing a usability engineering process complying with iec 62366.
This table maps the clauses and subclause of iec 6060116. Nov 01, 2011 in the past, when iec 62304 didnt exist, only iec 606011 dealt with software. At the brussels meeting, iecsc 62a accepted a proposal, based on isotc 121sc 3 resolution orebro 6, to develop the 1 st amendment to iec 6060118. For example, iec 341 is now referred to as iec 600341. A free webinar on the 15 steps devicemakers needs to complete to get approval to the iec 606011 series of standards. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding. The part 1 standard, en 606011 covers basic safety and essential performance for all medical electrical equipment and the part 2 or particular standards cover requirements for specific product groups e. En 60601 medical electrical equipment and systems bsi. This particular standard amends and supplements iec 606011 third edition, 2005 and amendment 1, 2012. Iec 606011 medical design standards for power supplies cui inc.
General requirements for safety collateral standard. Other collateral standards include 60601, covering radiation protection for diagnostic xray systems. If the iec 606011 standard is applicable, determine the set of collateral standards of iec 606011x are applicable. Iec 60601 1 is the basis for the whole series of collateral and particular iec standards. The third edition of iec 60601 1 6 was published in 2010. May 15, 2012 hi marcelo, my company manufactures a medical device software used in radiology. While the application of risk management principles have been clarified, the amended standard includes new. Regulatory implementation timetable for iec 606011 edition 3.
The evaluation package is a summary of the iec 606011. Nov 20, 2012 iec 60601 1 6 current latest edition 2010 iec 62366 current latest edition 2007 software iec 60601 1 4 current latest edition 2000 iec 62304 current latest edition 2006 i will cover details of each of these 3 areas in subsequent device tips. The third edition created a bridge that enables a manufacturer to conform to the requirements in iec 606011 that make normative reference to iec 6060116 by employing a usability engineering process complying with iec 62366. Iec 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment.
Speed your time to market by following the stepbystep instructions, leo the iec 606011 expert, will discuss in this free, 90 minute webinar so you can obtain your product certification to iec 606011 series of standards quicker. We leverage our product qualification and emc expertise to help ensure that your medical devices and products are in compliance with iec 60601 standards, and ready for. 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. May, 2019 iec 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment. Iec6060116 medical electrical equipment part 1 6 general.
Cei en 6060116a1 medical electrical equipment part 1. For now it is important to understand that these 3 are not separate areas in and of themselves. Consolidated editions the iec is now publishing consolidated versions of its publications. Iec 60601 essential performance, safety and risk management. In the past, when iec 62304 didnt exist, only iec 60601 1 dealt with software. Isotc 121sc 3 joint working group 2, alarms, was reactivated as a maintenance team to develop this amendment. It is technically equivalent to the international standard iec 60601 and the family comprises over 70 separate standards. Amendment 1 medical device software software life cycle processes. Cei en 6060116a1 medical electrical equipment part. Regulatory implementation timetable for iec 60601 1 edition 3. Bs en 6060116 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems. Din en 6060116 201602 medizinische elektrische gerate teil 16. Iec 6060116 iec 62366 usability engineering general comments no fishing allowed the most common mistake in applying usability standards is to assume that they are a kind of fishing expedition to find the weak points with the device, through extensive trialling with real users.
Iec 6060116, the usability collateral standard for medical electrical equipment, was the base for iec 62366. It is a collateral standard its objective is to specify requirements that are in addition to those of the general standard. Iec 60601 medical device safety testing used in countries around the world, iec 60601 helps ensure the safety and effectiveness of electrical and electronic medical devices. In the past, when iec 62304 didnt exist, only iec 606011 dealt with software. 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 606011 3rd edition, part 1 differences bob duffy. Iec 6060116, usability, in determining what information must be presented. Collateral standards such as 60601 1 6, provide more information than contained in the general standard. It is a widely recognized standard that most, if not all, medical device companies have to comply with. Iec 60601 1 6 iec 62366 usability engineering general comments no fishing allowed the most common mistake in applying usability standards is to assume that they are a kind of fishing expedition to find the weak points with the device, through extensive trialling with real users. Iec 606011 medical design standards for power supplies. The evaluation package is a summary of the iec 60601 1.
Din en 6060116 201010 medizinische elektrische gerate teil 16. In the future, iec 62366 will completely replace iec 60601 1 6. So, the big difference between iec 606011 and iec 62304 is the work of software not system architectural design and software not system integration. Iec 6060116 current latest edition 2010 iec 62366 current latest edition 2007 software iec 6060114 current latest edition 2000 iec 62304 current latest edition 2006 i will cover details of each of these 3 areas in subsequent device tips. Manufacturers of medical electrical equipment who comply with iec 6060116 need to also comply by extension to iec 62366 as part of iec 606011 edition 3. Note some systems which incorporate software and are used for medical purposes fall outside the scope of this collateral standard, e. Our list of applicable standard included iec 606011. For ce marking determine the harmonized standard sets in the en 606011x and are below.
It also includes information and interpretations for the clause requirements, as applicable. Although emission and immunity tests for medical products are very similar to those applied to. Lets start with some history with where the project started. To further assist the user of this collateral standard, table c. While 60601 1 is the basic general standard, particular standards branch off into specific devices, such as high frequency surgical, endoscopic equipment, and infant incubators. Sections one through six of 60601 1 6 environmental considerations, protection against electrical shock hazards and mechanical hazards are very close to the general standard. Speed your time to market by following the stepbystep instructions, leo the iec 606011 expert, will discuss in this free. Consequently, the second edition of iec 6060116 was developed specifically to align with iec. En 60601 or iec 60601 is the european harmonized standard to meet the medical device directive. Iec 60601 is a series of technical standards that ensure the safety of medical electrical equipment. So, the big difference between iec 60601 1 and iec 62304 is the work of software not system architectural design and software not system integration. We previously discussed the first two sections in part 1. Xx wont be aligned and published to the amendments project until about early 2022, and tc 62 wont start work on the 4 th edition of iec 60601. Iec6060116 medical electrical equipment part 1 6 general requirements for basic safety and essential performance collateral standard usability iec6060116 edition 3.
As from 1 january 1997 all iec publications are issued with a designation in the 60000 series. Is iec 606011 applicable to softwareonly medical devices. Iec 606011 for medical electrical equipment tuv sud. Hi marcelo, my company manufactures a medical device software used in radiology. General requirements for basic safety and essential performance gives general requirements of the series of standards. But as software became more prominent in pems, it was decided to add a standard only about software. Within iec 606011, there are collateral standards that are denoted as iec 606011x. The distinguishing factorcriterion is whether or not the system satisfies the definition of medical electrical equipment in 2. Apr 05, 20 then iec 62304 shouldnt be mandatory and it should be possible to apply iec 60601 1 standard alone.
Consequently, the second edition of iec 6060116 was developed specifically to align with iec 606011. Usability standard iec 6060116 in the medical device. Iec 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the international electrotechnical commission. To assist the user of this collateral standard in migrating from 6060116. The general standard iec 60601 1 medical electrical equipment part 1. Iec 60601 1 6, the usability collateral standard for medical electrical equipment, was the base for iec 62366. Our list of applicable standard included iec 60601 1 1, iec 60601 1 4, and iec 60601 1 6. In the future, iec 62366 will completely replace iec 6060116. Or download the pdf of the directive or of the official journal for free this website uses cookies to ensure you get the best experience on our website.