The interpretation sheet is available from document center inc. This consolidated version of iec 60601 244 is based on the second edition 2001. The 4th edition expands on the risk analysis approach developed previously by delving more deeply into what we might simply call emc concerns. These standards amend the clauses of the basic standard. Standards subscriptions from ansi provides a moneysaving, multiuser solution for accessing standards. This fourth edition cancels and replaces the third edition of iec 60601 12, and constitutes a technical revision. Iec 60601 is a widely accepted series of international standards for the basic safety and essential performance of medical electrical equipment. Iec 60601 1 zec 60601 12 iec 60601 14 iec 60601 210 leg 60601 1. They are in addition to the requirements of the general standard iec 60601 1 and serve as the basis for particular standards. Jul 19, 2016 iec 60601 1 is a lengthy, complex electrical safety standard. Iec 606011 medical electrical equipment part 1 tdklambda emea. The primary standard governing medical device design is formally known as iec 606011. Given the size of the original standard and the complexity of the changes, implementing the changes can seem overwhelming.
Common aspects of electrical equipment used in medical practice, of iec technical committee 62. This second edition of 6060111 cancels and replaces the first edition published in 1992 and its amendment 11995 and constitutes a technical revision. The major thrust of the 60601 1 standard is to require two levels of protection to shield operators and patients from getting hurt. In the united states, for example, the local version of iec 60601 1 is the ansiul 26011 standard. Iec 606011 medical design standards for power supplies cui inc. Be prepared for the 4th edition of the iec 606011 medical. Globtek applies for iec 606011 medical safety approvals and emc approvals on their standard power supply products. General requirements for basic safety and essential performance. This standard is identical with, and has been reproduced from, iec 60601 225, ed. Iec6060116 medical electrical equipment part 1 6 general. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. 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 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the international electrotechnical commission. The evaluation package is a summary of the iec 60601 1.
Be prepared for the 4th edition of the iec 60601 1 medical standard date 10162017 pdf. This standard can be used in part to show compliance under the usfda, canadahealth canada, and eu medical device directive 200747ec regulations. Other collateral standards include 60601, covering radiation protection for diagnostic xray systems, 60601 19 relating to environmental design, and 60601 111 recently introduced for home healthcare equipment. Standard references iec 60601 12, 3rdedition undated iec 60601 12, 4th edition dated undated reference the current version in publication, no grandfathering. Iec 6010112 4th edition was released in 2014 and will be required after december 31st, 2018. Particular requirements for the safety of xray equipment for. Mar 03, 2014 the standard is a complementary document to the iec 606011, medical electrical equipment part 1. The new iec 60601 12 collateral standard describes. Are the documents at the ansi webstore in electronic adobe acrobat pdf format only.
Such equipment is subject to federal radiation standards 21cfr part 1020 promulgated under the radiation control for health and safety act of 1968. This collateral standard to iec 60601 1 specifies general requirements and tests for basic safety. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment eie co. 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. The national differences and group differences, national deviations, special national conditions snc and regulatory requirements, are based solely on information provided to the secretariat by the iecee member bodies andor ncbs and other sources. International standard iec 60601 12 has been prepared by subcommittee 62a. 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 medical approvals for safety and emc are required to exist in separate cb reports. This document does not apply to the implantable parts of active implantable medical devices covered by iso 14708. It is a collateral standard its objective is to specify requirements that are in addition to those of the general standard. General requirements for basic safety and essential performance, has just had interpretation sheet 3 released. In engineering and design, part of being prepared means keeping abreast of changing. General requirements for basic safety and essential performance collateral standard. The most significant changes with respect to the previous edition include the following modifications.
The 60601 1 collateral standard for medical emc is 60601 12, presently the 3rd edition of the standard is in force. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. What are the new iec 60601 12 4 th edition requirements. The numbering of sections, clauses and subclauses of this particular standard corresponds with that of the general standard. This standard is intended to be read in conjunction with asnzs iec 60601. Globtek applies for iec 60601 1 medical safety approvals and emc approvals on their standard power supply products. Mopp and moop in iec 606011 3rd mouser electronics. General requirements for basic safety and essential performance gives general requirements of the series of standards. En 60601 3rd edition version has a cessation date of december 2017, but devices for which annex zz of the standard is applicable face a compliance date of 1 january 2016.
The purpose of this standard is to ensure that stray radiation is kept to a minimum for the safety of patient and operator. Important changes need to know iec 60601 12 applies to the electromagnetic compatibility emc of electrical medical equipment. Although complementary with iec 60601, the new standard is less complex and incorporates tests beyond those of type testing. The following is tool for evaluating medical equipment labeling and user manuals to the requirements of the 60601 1 standards.
The general standard iec 60601 1 medical equip mentmedicali electrical equipment part 1. Each countrys testing agencies and regulatory bodies are. Test report en 60601 1 medical electrical equipment part 1. This first edition cancels and replaces the first edition of iec 60601 238, published in 1996, and its amendment 1 1999. The standards are used in conjunction with the basic standard iec 60601 1, and follow the same clause numbering system. To put it bluntly, many things just dont make sense. This standard is identical with, and has been reproduced from iec 6060122, ed. The set of iec 606011 collateral standards each address a particular situation or equipment that is not addressed in the main document. Iec 60601 1 is an international standard and applies to the basic safety and essential performance of electrical medical equipment and electrical medical systems, referenced as me equipment and me systems. Iec 606011 medical design standards for power supplies.
It is already acceptable to use the standard in some markets, and many. This does not replace the standards, and a purchased copy of the iec and national standards should also be used. 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. This second edition is a collateral standard to iec 606011. Note, however, that complying with the 60601 1 standard isnt the same as fda approval. In the following post we will take a look at what the iec 60601 12 4 th edition emc collateral standard calls for, how it relates to medical power supplies, and most importantly when it goes into effect in each region, so that you can be ready. The motto of the worldwide scout movement, be prepared, is a good mantra for all aspects of life and, in business, is undeniably the key to success. Ad related to iec 60601 1 checklist iec 60601 standard. The warning should include a use distance such as be used no closer than 30 cm 12 inches to any part of the me equipment or me system, including cables specified by the manufacturer 5. New medical emc standard iec 6060112 4th edition globtek. 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. International standard iec 60601 244 has been prepared by subcommittee 62b.
Medical device approval and standards prepared by ph. This second edition of 60601 11 cancels and replaces the first edition published in 1992 and its amendment 11995 and constitutes a technical revision. The table below lists all of the iec 60601 2x standards for particular types of medical equipment. 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. Also, our implementation of the amendment is late and has not been published yet it will probably go to public consultation this month. The standard has of course been updated to fit with iec 60601 1. Medical standards iec 60601 1 medical equipment part 1 general requirements for safety.
However in december 2018 newly certified or recertified medical devices will be required to meet the. Iec 606011 amendment 1 3rd edition and brazil abnt nbr. Diagnostic imaging equipment, of iec technical committee 62. Iec6060116 medical electrical equipment part 1 6 general requirements for basic safety and essential performance collateral standard. Also, similar to iec 60601 227, the opportunity has been taken to. However in december 2018 newly certified or recertified medical devices will be required to meet the more rigorous requirements from the 4th edition. This consolidated version of iec 60601 12 is based on the second edition 2001 documents.
For brevity, iec 60601 1 is referred to in this particular standard either as the general standard or as the general requirements, and iec 60601 12 and iec 60601 14 as the collateral standards. Required if mitigating fire, shock, or mechanical hazards in n. Missing page numbers correspond to the frenchlanguage pages. Iecen 606011 basic safety and essential performance of. The object of this standard is to specify general requirements for the safety of medical electrical equipment and to serve as the basis for the safety requirements of particular. The standard contains tables with allowable values relating to different editions of iec 60601 1 and includes general requirements and further clauses for special types of medical electrical equipment and systems. The general standard iec 606011 medical electrical equipment part 1. 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. This second edition is a collateral standard to iec 60601 1. General requirements for safety, hereinafter referred to as the general standard, and. Detailed information about joint australiannew zealand standards can be found by visiting the standards webshop in australia at au or standards new zealands website at. The iec 606011 is the general overview document for the iec 60601. There is often confusion regarding the differences between iec 60601 1 ed 3, and iec 60601 1 ed 3.