Risk Management in IEC 60601-1 Third Edition
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.
Risk Management at the core of 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”
The 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, and requires this aspect to be evaluated according to ISO 14971.
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.
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