EU adopts IEC 60601-1:2005 - 3rd Edition - November 30, 2006
March 7, 2007--Although IEC 60601-1:2005 standard was officially adopted by CEN as a European Norm on 30 November 2006, the standard has not yet been published in the official journal of the European Union as a harmonized standard for the Medical Devices Directive 93/42/EEC.
At the present moment only the 2nd edition of the standard (with all amendments) provides the presumption of conformity to specific essential requirements. When the 3rd edition is harmonized a transition period will be established. During this transition period both the 2nd and 3rd editions of the standard will provide a presumption of conformity. At the end of the transition period the 2nd edition will be withdrawn as a harmonized standard and so will no longer provide a presumption of conformity. The transition period is designed specifically to allow manufacturers time to assess the changes in the standard and make any design changes and verification to the new standard to ensure that every time they place the CE mark on their products, the products continue to provide a level of safety commensurate with the generally acknowledged state of the art (Essential Requirements).
Fundamental changes have accompanied the transition from the second edition (1988) to the third edition (2005) of this standard. In addition to making structural changes to the standard, the third edition takes on a broader range of products and has been modernized to take account of the past ten years of technological evolution and a different approach to standards development.
One of the most significant changes accompanying the third edition is the requirement for risk management. Clause 4.2 of the third edition states: “A risk management process complying with ISO 14971 shall be performed.” Thus, to meet the requirements of the third edition, one must also comply with ISO 14971.
This single statement integrates process-based requirements into a test standard, which will have a significant impact on both manufacturers and Certification Organizations (COs). The manufacturer's risk management process is used throughout the third edition to determine whether a particular requirement is applicable or not applicable; whether an alternative requirement can be substituted; and whether it can be satisfied with alternative test criteria or testing procedures.
Clause 4.5 of the third edition allows the manufacturer to use an alternative means of managing any risk addressed by the standard, so long as the residual risk (estimated as part of the risk management process) can be demonstrated to be smaller. So, instead of designing a product to meet the third edition, risk management is used to design a standard the device must meet.
What does the establishment of this risk management process mean for COs such as Underwriters Laboratories? Test parameters and even the application of specific tests can vary from device to device, depending on the intended use and resultant acceptable risk(s). This, in turn, raises the question of how this impacts a CO's ability to conduct testing cheaply and efficiently.
Furthermore, COs will want to seek many parts (if not all) of the manufacturer’s risk management file, since the third edition has over 100 compliance statements where evidence of compliance is to be found in the risk management file. Thus, the documentation needed for certification will probably increase significantly. Since one must have an ISO 14971 risk management process in place to conform to the third edition, it is logical that COs will want to assess the manufacturer's risk management process as part of the certification process, as they now do for certification to the collateral standard for programmable electro-medical systems. Thus, certification to the third edition of IEC 60601-1 will probably include some sort of onsite audit to assess the manufacturer’s compliance to ISO 14971.
Contributed by Harvey Rudolph, PhD, Underwriters Laboratories Medical Business Unit.