Iec 606011 medical design standards for power supplies cui inc. Although this standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety. Iec 60601 body model to ensure a standardised method of simulating the impedance of the human body, measurement circuits have been designed to simulate the average, typical electrical characteristics of the human body. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
General requirements for basic safety and essential performance collateral standard. Within iec 606011, there are collateral standards that are denoted as iec 606011x. This document cancels and replaces the first edition of iec 60601 1 3, published in 1994 which replaced iec 407 issued in 1973. For 3rd edition amendment 1 iec606011am1 july, 2012 3rd edition interpretation 2 interpretation sheet 2 for 3rd edition jan. 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. This means that certification to iec 606011 is not possible without compliance with. 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. It may not be duplicated without prior written consent of bontek compliance laboratory ltd.
The evaluation package is a summary of the iec 60601 1. It consists of the third edition 2010 documents 62a682fdis and 62a689rvd and its amendment. Download pain 233 is tta e ptta nbr iec 60439 1 pdf from 4 mb, norma abnt nbr iec 60601 1 zip from 373 mb free from tradownload. In order to reduce the risk as much as possible, the standard for medical electrical equipment and systems stipulates means of protection mop. Changes from 2nd to 3rd edition 60601 second edition 60601 3rd edition deadline. The 606011 collateral standard for medical emc is 6060112, presently the 3rd edition of the standard is in force. General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems. These measurement circuits are referred to as a body model or measuring device md in iec 60601 1. While the application of risk management principles have been clarified, the amended standard. 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. The iec 60601 1 2 committee released a revised version of this standard in 2014 edition 4 to replace the previous version from 2007 edition 3. The iec 60601 1 and iec 60601 1 2 medical electrical equipment package specifically address the electromagnetic compatibility of medcial electrical equipment. The iec 6060112 committee released a revised version of this standard in 2014 edition 4 to replace the previous version from 2007 edition 3.
Replace, in the amendment section, the existing reference. A risk management process according to iso 14971 shall be performed. The medical approvals for safety and emc are required to exist in separate cb reports. Specific respective tests were performed in accordance with basic standard versions as follows. Common aspects of electrical equipment used in medical practice, of iec technical committee 62. Globtek applies for iec 606011 medical safety approvals and emc approvals on their standard power supply products. This consolida ted version of iec 60601 1 6 bears the edition number 3. We have produced our free guide to iec 60601 as a guideline for people involved in testing medical devices, an important part of keeping people safe. Third edition of iec 606011 3rd edition iec 60601 60601 third edition changes iec 60601 1 first edition 606011 edition 3. Iec 606011 is intended to serve as a tool in the risk management process. International standard iec 60601 1 2 has been prepared by subcommittee 62a.
Fill out the form on this page to download the guide and understand the commonly used definitions withing iec 60601, testing requirements, and the importance of regular device testing in order to. For the purposes of this document, the terms and definitions given in iec 6 0601 1. Globtek applies for iec 60601 1 medical safety approvals and emc approvals on their standard power supply products. The general standard iec 606011 medical electrical equipment part 1.
The evaluation package is a summary of the iec 606011. Iec 606011 medical design standards for power supplies. The 60601 1 collateral standard for medical emc is 60601 1 2, presently the 3rd edition of the standard is in force. Iec 60601 1 and iec 60601 1 2 medical electrical equipment package includes. What are the marking and labeling requirements for the device. The general standard iec 60601 1 medical electrical equipment part 1.
Iec 606011 and iec 6060112 medical electrical equipment. Replace, in the amendment section, the existing reference iec 60601 12, including its title, by the following new reference. A vertical line in the margin shows where the base publication has been modified by. This consolidated version of iec 60601 1 2 is based on the second edition 2001 documents. Other collateral standards include 60601, covering radiation protection for diagnostic xray systems. Our filtering technology ensures that only latest nbr iec 60601. Iec 606011 and iec 6060112 medical electrical equipment package includes. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding. General requirements for basic safety and essential performance gives general requirements of the series of standards. What you need to know to classify your products to the iec 606011 series. Aug 07, 2018 iec 606011 third edition amendment 1 ed. General requirements for basic safety and essential performance iec 60601 1.
This test report is limited to the above client company and the product model only. 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. This standard applies to the safety of medical electrical equipment as defined in subclause 2. These measurement circuits are referred to as a body model or measuring device md in iec 606011. General requirements forbasic safety and essential performance collateral standard. General requirements for basic safety and essential performance collateral s tandard. The iec 606011 and iec 6060112 medical electrical equipment package specifically address the electromagnetic compatibility of medcial electrical equipment. However in december 2018 newly certified or recertified medical devices will be required to meet the more rigorous requirements from the 4th edition. Presentation mode open print download current view.
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. 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. This document cancels and replaces the second edition of iec 6060116 which has been technically revised. This consolida ted version of iec 6060116 bears the edition number 3. 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. Therefore, no need to order amendment in addition to this publication. General requirements for basic safety and essential performance. Basic standard version subject en 55011 a1 cispr 11 a1 2009 2010 2009 2010 emissions en 632 iec 632 2014 2014 harmonic current en 633 iec 633. In this article, we detail the differences between these versions as well as provide information about the implementation dates in the us fda and eu european union.
957 691 1108 481 789 33 1482 1271 460 1106 886 104 268 1217 1499 746 456 790 1623 192 1558 714 83 1160 283 965 1358 688 749 1053