International standard iec 60601 12 has been prepared by subcommittee 62a. What are the new iec 6060112 4 th edition requirements. Guidance for industry and fda staff laser products. Standard references iec 6060112, 3rdedition undated iec 6060112, 4th edition dated undated reference the current version in publication, no grandfathering. Collateral standards within iec 606011, there are collateral standards that are denoted as iec 606011x. 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. In the iec 60601 series, particular standards may modify, replace or delete requirements contained in this standard as appropriate for the. This second edition of 6060111 cancels and replaces the first edition published in. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of iec 60601225 and iec 60601251 into one standard. General requirements for basic safety and essential performance. A particular standard takes priority over this general standard.
Collateral standards within iec 60601 1, there are collateral standards that are denoted as iec 60601 1x. Electromedical equipment, of iec technical committee 62. The standards are used in conjunction with the basic standard iec 606011, and follow the same clause numbering system. Over time the iec 606011 standard has reflected the changing situations within which medical equipment is used. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. General requirements for basic safety and essential performance, has just had interpretation sheet 3 released. The original premise of the standard is mirrored by its full title iec 606011 medical electrical equipment part 1. This third edition constitutes a collateral standard to iec 606011. The primary standard governing medical device design is formally known as iec 606011. Test report iec 606011 en 60601 1 medical electrical. This second edition of iec 60601225 constitutes a technical revision of both those standards. They are in addition to the requirements of the general standard iec 606011 and serve as the basis for particular standards. The iec 606011 standard, medical electrical equipmentpart 1.
Common aspects of electrical equipment used in medical practice, of iec technical committee 62. In the iec 601 series, collateral standards specify general requirements for safety applicable to. However in december 2018 newly certified or recertified medical devices will be required to meet the. There are also deviations from the standard that relate to countryspecific requirements. Iec 6060112 testing iec 6060112 4th edition standard. General requirements for safety, is the cornerstone document addressing many of the risks associated with electrical medical equipment. This particular standard amends and supplements iec 60601 1. International standards for all electrical, electronic and related technologies. This collateral standard to iec 606011 specifies general requirements and tests for basic safety. The iec shall not be held responsible for identifying any or all such patent rights. Missing page numbers correspond to the frenchlanguage pages. 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. The text of this standard is based on the following documents. Be prepared for the 4th edition of the iec 606011 medical.
International standard iec 6060111 has been prepared by subcommittee 62a. Iec 606011 pdf archives document centers standards forum. Iec 606011 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. 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. General requirements for basic safety and essential performance collateral standard. The medical device developers guide to iec 606011 601help. Your new and existing medical devices must demonstrate compliance with the. This standard is identical with, and has been reproduced from iec 606011 ed. Iec 606011 medical design standards for power supplies cui inc. International standard iec 60601241 has been prepared by subcommittee 62d. Iec 6060112 testing product certification services. All other published collateral standards in the iec 60601 1 series apply as published.
Cdrh plans to amend federal regulations for laser products to reflect those sections of the iec standards. Iec 6060112 4th edition medical electrical equipment part 12. The fourth edition iecen 6060112 4th edition will become a mandatory standard covering safety for medical devices on december 31, 2018. The most significant changes with respect to the previous edition include the following modifications. It is technically equivalent to the international standard iec 60601 and the family comprises over 70 separate standards. This fourth edition cancels and replaces the third edition of iec 6060112, and constitutes a technical revision. The 4th edition expands on the risk analysis approach developed previously by delving more deeply into what we might simply call emc concerns. The table below lists all of the iec 606012x standards for particular types of medical equipment. Emergency medical services are automatically classified as the home healthcare environment per clause 8. The evaluation package is a summary of the iec 606011. Iec 60601 is a series of technical standards for the safety and essential performance of. Iec 6060112 is a collateral standard that applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems.
Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. 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. En 60601 medical electrical equipment and systems bsi. 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. 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. These standards amend the clauses of the basic standard. En 60601 is a family of standards whose scope covers the safety, essential performance and electromagnetic compatibility of medical electrical equipment and systems. Although emission and immunity tests for medical products are very similar to those applied to. Ensuring that a device complies with iec 60601 can be a complex, multifaceted task. International standard iec 6060112 has been prepared by subcommittee 62a. Iecen 606011 basic safety and essential performance of. In the 6iec0601 series, particular standards may modify, replace or delete requirements.
The iec 60601 series does not apply to most types of in vitro diagnostic equipment addressed in the iec 61010 series of standards, or to implantable parts. Mopp and moop in iec 606011 3rd mouser electronics. The iec 606011 is the general overview document for the iec 60601 series. This document cancels and replaces the first edition of iec 60601, published in 1994 which replaced iec 407 issued in 1973. This consolidated version of iec 60601 12 is based on the second edition 2001 documents. The standard also indicates that increased test levels above and beyond the home healthcare test levels may be appropriate in some. Iec 606011 medical design standards for power supplies. Electromagnetic disturbances requirements and tests.
Or download the pdf of the directive or of the official journal for free. This standard can be used in part to show compliance under the usfda, canadahealth canada, and eu medical device directive 200747ec regulations. The interpretation sheet is available from document center inc. The evaluation package is a summary of the iec 60601 1. Is emergency medical iec 60601112 always a special environment. This collateral standard to iec 606011 specifies general requirements and tests for basic safety and essential. Iec 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the international electrotechnical commission. Iec 60601 is a widely accepted series of international standards for the basic safety and essential performance of medical electrical equipment.
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