Iec 60601 1 3rd edition compliance management one of the biggest challenges facing our clients today is compliance with the third edition of iec 60601 1 because it represents such a radical change from its predecessor. 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. Understanding essential performance for iec 606011 third edition. Iec 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the international electrotechnical commission. They are in addition to the requirements of the general standard iec 606011 and serve as the basis for particular standards. Gap analysis between the second and third editions of iec 60601 1 iec 60601 1. This fourth edition cancels and replaces the third edition of iec 60601 1 2, and constitutes a technical revision. It consists of the third edition 2010 documents 62a682fdis and 62a689rvd and its amendment 1 20 documents 62a890fdis and 62a898rvd. Therefore, no need to order amendment in addition to this publication.
Missing page numbers correspond to the frenchlanguage pages. This consolidated version of iec 6060118 consists of the second edition 2006. Includes all amendments and changes through changeamendment, april 2000. Seven additional recommendations have been developed by iecsc 62awg 14 and are included in this edition of iectr 62296. This is a preiew edition of an aami uidance document and is. 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. General requirements for basic safety and essential performance collateral standard. The 3rd edition of iec 606011 represents a shift in philosophy from the 2nd. This edition has been restructured and aligned to iec 60601 1 2005 and focussed on general requirements for radiation protection that apply to all diagnostic xray equipment. For the purposes of this subclause, the width of a finger is considered to be 1. In anticipation of a third edition of iec 606011, iec subcommittee 62a prepared a second edition of iectr 605 121 in 1994. Essential performance is not new to the third edition, it is more defined the performance necessary to achieve freedom from unacceptable risk. The 2nd edition, published in 1988, focused on safety within the vicinity of a patient. This consolidated version of iec 60601 1 2 is based on the second edition 2001 documents.
General requirements for basic safety and essential performance. This bundled threeday course will help you gain a thorough understanding of how to use iec 606011 and ul 606011 effectively along with the changes that will be brought about by the issuance of iec 606011, 3rd edition. The current version of the standard is thus called iec 606011. Notice additional guidance on transition from the second. This document cancels and replaces the second edition of iec 6060116 which has been technically revised. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding.
For medical devices, the report covers the iec 606011 base standard, applicable collateral and particular standards, as well as national differences. A vertical line in the margin shows where the base publication has been modified by amendment 1. International standard iec 60601 1 2 has been prepared by subcommittee 62a. International iec standard 6060112 pdf book manual free.
For example, a laser device used for the removal of. Iec shall not be held responsible for identifying any or all such patent rights. In some jurisdictions, such as south korea, regulators have only recently adopted the requirements of iec 60601 1 edition 3. It is, therefore, generally not possible to obtain successful registration in china with products developed and documented according to the 3rd edition. This document cancels and replaces the first edition of iec 60601, published in 1994 which replaced iec 407 issued in 1973.
International standard iec 6060112 has been prepared by subcommittee 62a. Note 1 this interpretation sheet is intended to be used with both edition 3. As the third edition of iec 606011 has been published, some of the recommendations in the second edition of iectr 62296 have been changed to align with requirements in iec 606011. Some major import countries for such equipment have started to enforce the implementation of the third edition as early as january 2014. Iec 60601 1 is currently at the second edition, published in 1988, and has undergone two amendments.
Iec 606011 medical design standards cui inc medtech engine. This fourth edition cancels and replaces the third edition of iec 6060112, and constitutes a technical revision. For medical devices, the report covers the iec 60601 1 base standard, applicable collateral and particular standards, as well as national differences. This second edition cancels and replaces the first edition of iec 60601 1 11, published in 2010, and constitutes a technical revision. Seven additional recommendations have been developed by iec sc 62awg 14 and are included in this edition of iec tr 62296. The most significant changes with respect to the previous edition include the following modifications. To avoid being denied entry into these and other markets, manufacturers should ensure. Common aspects of electrical equipment used in medical practice, of iec technical committee 62.
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. Working document for nbrg frequently asked questions. We are now approaching the end of the project to develop the third edition, with the final draft international standard fdis due for circulation in may. Gap analysis between the second and third editions of iec. Designing for compliance to iec 606011, 2nd edition and transition to the 3rd edition bundled workshop description. Amendment 2 to the second edition added subclause 1. Sep 01, 2003 the scope of tc 62 is electrical equipment in medical practice. It is the 3rd edition of the basic standard, replacing the previous version iec 606011. Iec 6060112, second edition, introduces the concept of essential performance which is being incorporated into the draft third edition of iec 606011.
Iec 60601 1 first edition 3rd edition 606011 60601 third edition changes 606011 second edition 606011 edition 3. Manufacturers developing and marketing medical devices have a staggering number of regulations, guidances, and industry standards to master. This document cancels and replaces the second edition of iec 60601 1 6 which has been technically revised. Gap analysis between the second and third editions of iec 606011 iec 606011. The facilitator in the united states for iec 60601 1 is the american national standards institute ansi. As with any other standard change, a failure to implement these new requirements in. In october, 2008, health canada published a notice indicating that until june 1, 2012, conformity to the second edition of iec 606011 and its related collateral and particular standards would be accepted. How long do i have to comply with iec 60601 1 2 4 th edition. For emc, refer to the collateral standard, iec 6060112. The mainstay of safety standards in all the rapidly evolving technology of electromedical equipment, the second 1988 edition of iec 601 1 called for updating through this first amendment. This document cancels and replaces the first edition of iec 60601 1 3, published in 1994 which replaced iec 407 issued in 1973.
See iec 606011 national differences list of standards. This consolida ted version of iec 60601 1 6 bears the edition number 3. How long do i have to comply with iec 6060112 4 th edition. The general standard iec 60601 1 medical electrical equipment part 1. Changes from 2nd to 3rd edition 1800worldlab 1 introduction the 3rd edition of iec 606011 represents a shift in philosophy from the 2nd edition, including a greater emphasis on risk management and essential performance. It was revised to align with the usability engineering process in iec 62366. Electromagnetic compatibility requirements and tests.
Because the global shift to iec 606011 3rd edition is still underway, 2nd and 3rd edition standards must still coexist in equipment intended to ship internationally. General requirements for safety collateral standard. Aug 07, 2018 iec 606011 third edition amendment 1 ed. Note 2 an example of an analysis that demonstrates an adequately low probability of occurrence of harm is. This consolidated version of iec 6060112 is based on the second edition 2001 documents. General requirements for basic safety and essential performance gives general requirements of the series of standards. Unlike the second edition which addresses risk management in a relatively limited fashion, the third. For laboratory equipment, the report covers the iec 61010 1 base standard and applicable particular standards.
This article, originally published in 20 summarises the changes. 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. The mainstay of safety standards in all the rapidly evolving technology of electromedical equipment, the second 1988 edition of iec 6011 called for updating through this first amendment. 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. Electromagnetic disturbances requirements and tests. 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. While the application of risk management principles have been clarified, the amended standard. Equipment intended for professional, industrialprocess, industrialmanufacturing and.
Iec 606011 3rd edition compliance management one of the biggest challenges facing our clients today is compliance with the third edition of iec 606011 because it represents such a radical change from its predecessor. They are in addition to the requirements of the general standard iec 60601 1 and serve as the basis for particular standards. Iec 606011 medical design standards for power supplies cui inc. This consolidated version of iec 6060112 is based on the second edition 2001 documents 62a336fdis and 62a341rvd and its amendment 1 2004 documents 62a462fdis and 62a469rvd.
In some jurisdictions, such as south korea, regulators have only recently adopted the requirements of iec 606011 edition 3. En 606011 issues first nbmed released version page 5 v1. In 2005, the iec released the 3rd edition, which reflected a further change of. The national electrotechnical committees around the world have submitted several thousand comments on successive drafts, which have resulted in a lot of changes to the details, but the. This second edition cancels and replaces the first edition of iec 60601111, published in 2010, and constitutes a technical revision. See iec 60601 1 national differences list of standards. Gap analysis between the second and third editions of iec 606011. International iec standard 6060112 pdf book manual. It is the 3rd edition of the basic standard, replacing the previous version iec 60601 1.
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. In the second edition, the essential performance was covered in clause 3. Each countrys testing agencies and regulatory bodies are. For example, the iec 60601 1 2 becomes yy 0505 and the second edition of iec 60601 1 is identical to chinese standard gb 9706. Working document for nbrg frequently asked questions related. Iec 606011 for medical electrical equipment tuv sud. Edition, including a greater emphasis on risk management and essential. The current version of the standard is thus called iec 60601 1.
Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Designing for compliance to iec 606011, 2nd edition and. The 3rd edition of iec 606011 has not yet been adopted in china and no clear timetable exists. Understanding essential performance for iec 606011 third. For laboratory equipment, the report covers the iec 610101 base standard and applicable particular standards. As the third edition of iec 60601 1 has been published, some of the recommendations in the second edition of iec tr 62296 have been changed to align with requirements in iec 60601 1. The 3rd edition of iec 60601 1 has not yet been adopted in china and no clear timetable exists. The global timeline for compliance with the various editions of iec 60601 1, including the 4 th edition emc standards is fully detailed here. This consolida ted version of iec 6060116 bears the edition number 3. Currently, health canada recognizes both the second edition of iec 606011, published in 1988, and the third edition, published in 2005. The global timeline for compliance with the various editions of iec 606011, including the 4 th edition emc standards is fully detailed here. This consolidated version consists of the third edition 2010 and its amendment 1 20. The decision to title a standard with the prefix gb or yy depends on a wide variety of factors, including the submitted date for approval, the importance of the standard mandatory or recommended, and other.
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