The new revision replaces the 3rd edition, which is now obsolete. It constitutes a collateral standard to iec 606011. 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. This edition has been restructured and aligned to 60601 12005 andiec focussed. It consists of the third edition 2010 documents 62a682fdis and 62a689rvd and its amendment 1 20 documents 62a890fdis and 62a898rvd. Electromagnetic compatibility requirements and tests this norm is withdrawn since 12092007. Missing page numbers correspond to the frenchlanguage pages. A new 4th edition has just been released for iec 6060112, medical electrical equipment part 12. Oct 01, 2011 en 606011 issues final draft for nbmed comments v1. 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. After that date, they will only recognize docs which show testing according to the iec 6060112 edition 4. This particular document is geared for medical equipment that will operate.
This consolida ted version of iec 6060116 bears the edition number 3. Understanding the major technical revisions to medical emc standard iecen 6060112. En 60601 or iec 60601 is the european harmonized standard to meet the medical device directive. The evaluation package is a summary of the iec 606011. While this standard is broadly considered all encompassing, it is important to note that in addition to. Introduction this document is intended to clarify some of the many questions that relate to the implementation of en 606011. This third edition cancels and replaces the second edition of iec 60601222, published in 1995. It is technically equivalent to the international standard iec 60601 and the family comprises over 70 separate standards. General requirements for safety, hereinafter referred to as the general standard. Iec6060116 medical electrical equipment part 1 6 general requirements for basic safety and essential performance collateral standard usability iec6060116 edition 3. The primary standard governing medical device design is formally known as iec 606011. Programmable electrical medical systems specifies requirements for the process by which a programmable electrical medical system is designed. Iec 606011 is a lengthy, complex electrical safety standard.
Requirements for the development of physiologic closedloop controllers. This edition of iec 60601 12 was revised to structurally align it with the 2005 edition of iec 60601 1 and to implement the decision of iec subcommittee 62a that the clause numbering structure of collateral standards written to iec 60601 1. Pdf please note that paper format is currently unavailable. En 60601 medical electrical equipment and systems india. En 60601 medical electrical equipment and systems bsi. The technical content is identical to the base edition and its amendment.
Frequently asked questions related to implementation of en. If you are unsure as to which version to use, contact your intertek account manager or project engineer. Iec 606011 medical electrical equipment part 1 tdklambda emea. Bs en 6060111 is the european standard that applies to the safety of medical electrical systems. En 606011 issues final draft for nbmed comments v1. A norma 606011 tem uma particularidade quanto a aplicacao da tensao. En 606011 applies to all medical electrical equipment and medical electrical systems. This collateral standard to iec 60601 1 specifies general requirements and tests for basic safety. A list of all parts of the iec 60601 series, published under the general title medical electrical this is a free 7 page sample. En 60601 is a family of standards whose scope covers the safety, essential performance and electromagnetic compatibility of medical electrical equipment and systems. 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.
European union cemark the 3rd edition has been published as an en standard. It does not establish standards for effectiveness, but individual markets mandate a certain level of effectiveness in addition to the requirements of iec 60601. The evaluation package is a summary of the iec 60601 1. Understanding the major technical revisions of iecen 606011. International standard iec 6060114 has been prepared by iec technical committee 62. It is a collateral standard its objective is to specify requirements that are in addition to those of the general standard.
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 606011 medical design standards for power supplies. Bs en 6060112 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems. This consolida ted version of iec 60601 16 bears the edition number 3. En 60601 equipos y sistemas electricos medicos bsi. Jul 19, 2016 iec 60601 1 is a lengthy, complex electrical safety standard. Iec6060116 medical electrical equipment part 1 6 general. International standard iec 60601222 has been prepared by iec subcommittee 76. Understanding the major technical revisions to medical emc standard iecen 60601 12. This collateral standard to iec 606011 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of me equipment and me systems. This edition constitutes a collateral standard to iec 606011. Whaleteq provides the test solutions which assist you to validate and verify your product design with ease. General requirements for basic safety and essential performance.
Given the size of the original standard and the complexity of the changes, implementing the changes can seem overwhelming. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. Changes from 2nd to 3rd edition 3 of our clients are continuing to use the 2nd edition. Iec 606011 medical design standards for power supplies cui inc. We have been focusing on ecgekg test solutions compliant with medical standards for years and lately extended to eeg testing and wearable device performance testing for vital signs of ecg, ppg heart rate, spo2 and pwtt.
Instituciones laami association for the advancement of medical instrumentation. This edition of iec 6060112 was revised to structurally align it with the 2005 edition of iec 606011 and to implement the decision of iec subcommittee 62a that the clause numbering structure of collateral standards written to iec 606011. Bs en 6060111 covers the safety requirements for medical electrical systems to provide protection for patients, operators and their surroundings. General requirements for safety collateral standard.
Understanding the major technical revisions of iecen. The date of cessation of presumption of conformity of the. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. General requirements for basic safety and essential performancehereafter referred to as the general standard. General requirements for basic safety and essential performance collateral standard. Electromagnetic disturbances requirements and tests.
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