What is the IEC 60601-1?
The IEC 60601-1 standard, “Medical Electrical Equipment-Part 1: General Requirements for Safety”, is considered the fundamental 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.
Risk Management at the core of the standard
ISO 14971 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 through this document. These are a culmination of discussions the IEC's Subcommittee initiated as far back as 1996.
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 Edition requires this aspect to be evaluated according to ISO 14971.
Risk Management at all stages
Requirements of IEC 60601-1 Third Edition fall under these four categories:
1.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
2.It is used to determine equivalent safety for alternative compliance
3.It is used to determine compliance criteria
4.It 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.