IECEE MEE Task Force Issues Revised Risk Management Requirements Guidance for IEC 60601
November 10, 2008 // Published as a news service by IHS
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The International Electrotechnical Commission (IEC) System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE) Certification Management Committee (CMC) approved a report and guidance document on risk management requirements for the 3rd edition of IEC 60601-1 - medical electrical equipment.
The IECEE Medical Electrical Equipment (MEE) Task Force, which was formed in September 2007, created the report and guidance document.
The IECEE CMC requested that the task force develop a training workshop in April 2009 for certification bodies and testing laboratories operating under the IECEE system.
The purpose of the workshop is to provide an introduction to the implementation of International Organization for Standardization (ISO) 14971 within IEC 60601-1 medical electrical equipment.
The workshop will include introductory training, but subsequent ongoing training will be needed for testing and certification engineers and technical assessors as part of the IECEE Peer Assessment program, said the IECEE.
A program was developed by the task force and four working teams were formed to further develop the technical and the logistical administrative aspects for the program.
The task force put emphasis on using practical examples drawn from the various clauses of IEC 60601, which call up ISO 14971 risk management requirements. The intent is to use those examples to illustrate clauses that apply and how ISO 14971 requirements are to be put in place by manufacturers, said the IECEE.
The task force also discussed how to handle IEC 60601 collaterals, which become normative on the date of publication.
The IECEE Task Force will begin development of guidance documents to collaterals and the accompanying annexes to the test report form, but it recognizes the necessity for prioritization of the work on the collaterals and that transition time is defined.
Source: IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE).