IEC 60601-1 Third Edition: Essential Performance and Risk Management

  • Added:
    Dec 05, 2012
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What is the IEC 60601-1?

The IEC 60601-1 standard, “Medical Electrical Equipment—Part 1: General Requirements for Safety,” is considered the foundational document for electrical medical equipment. It goes a long way in addressing many of the risks associated with electrical medical equipment. Nearly justifying the long time taken for its development; this standard is a commendable attempt at correcting many of the risks and imbalances associated with the electrical medical equipment industry.

In the process of implementation

The IEC 60601-1 Third Edition was published in December 2005. Its development and publication took ten years, an unusually long time for such work. This extended timeframe was attributed to added clerical work such as the internal numbering of the clauses. This work was basically to help finders locate which clause from the earlier version had changed and which had not. Many countries are still in the process of adapting it fully, even though it was released all those years back.This slow pace of implementation has demonstrated that ensuring that a device complies with IEC 60601 can be a complex andpolygonal task.

Risk Management at the core of the standard

Risk Management is a critical factor in IEC 60601-1 Third Edition. This is one of the important additions that have been made to this edition from the previous one. The new legislation requires that Risk Management be implemented in the product lifecycle throughout the standard.

ISO 14971, which deals with application of Risk Management to medical devices, is deeply embedded into IEC 60601-1 Third Edition. Full application of ISO 14971 is mandated for all medical equipment complying with IEC 60601-1. Also, as many as 85 additional references are made to Risk Management throughout this document. These are a culmination of discussions the IEC’s Subcommittee initiated as far back as 1996.  The scope of this committee was to revise the IEC 60601-1 Standard’s general requirements for safety.

Safety as an “Essential Performance”

Another outstanding feature of this standard is that it takes a new look at safety. It makes safety an “Essential Performance”, a change from its predecessor’s scope that required only “Basic Safety”. By “Essential Performance” is meant that aspect of the electromedical device’s performance that can affect safety directly. EP is the measurable, repeatable and predictable ability of an electromedical device necessary to help achieve freedom from unacceptable risk. In other words, EP has to be considered by the standpoint of whether its absence or lowering would lead to an unacceptable risk. IEC 60601-1 Third Editionrequires this aspect to be evaluated according to ISO 14971.Placing heightened emphasis on this aspect is the defining difference between the second and third editions.

Risk Management at all stages

Risk Management requirements ofIEC 60601-1 Third Edition fall under these four categories:

-        Apart from general requirements set out in 14971; Risk Management must be used to determine whether additional hazards beyond those addressed in IEC 60601-1 Third Edition exist

-        Risk Management is used to determine equivalent safety for alternative compliance

-        Risk Management is used to determine compliance criteria

-        Risk Management is also used to determine or refine test methods.

Thus, Risk Management is incorporated into this standard, while it was vague and subjective in the 2nd edition of this standard.

Author's Profile

The IEC 60601-1 Third Edition was published in December 2005. Its development and publication took ten years, an unusually long time for such work. This extended timeframe was attributed to added clerical work such as the internal numbering of the clauses. http://www.mddionline.com/article/regulatory-strategies-third-edition-iec-60601-1 http://journals.jevon.org/users/globalpanel/tag/devices/ http://www.globalcompliancepanel.com/


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