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IEC/EN 60601-1 basic safety and essential performance of electrical medical equipment and electrical medical systems

Medical Device compliance regulations include includes basic safety and essential performance testing found under IEC 60601-1 for electrical medical equipment and electrical medical systems, referenced as ME equipment and ME systems. This standard can be used in part to show compliance under the US-FDA, Canada-Health Canada, and EU Medical Device Directive 2007/47/EC regulations.

IEC/EN 60601-1 requires the manufacturer to identify the essential performance and identify which functions of the ME equipment and ME systems are specific to the essential and intended performance. Where this standard specifies that ESSENTIAL PERFORMANCE is to be maintained following a particular test, these functions shall be used and compliance shall be checked by inspection, and if necessary, by functional test.
The object of this IEC/EN 60601-1 standard is to specify general requirements and to serve as the basis for particular or collateral standards.

Collateral standards in the IEC/EN 60601 series specify general requirements for basic safety and essential performance of a subgroup of ME equipment (e.g., radiological equipment), a specific characteristic of all ME equipment not fully addressed in this standard. Applicable collateral standards become normative at the date of their publication and shall apply together with this standard.

IEC 60601-1 identifies and defines the conditions and requirements related to RISK.
RISK is generally defined as the combination of the probability of occurrence of harm and the severity of that harm.

ISO 14971 is the most used standard for risk analysis and assessment.

Risk analysis is referenced as the systematic use of available information to identify and to estimate the risk.
Risk assessment is the overall process taken by the manufacturer when comprising the risk analysis and the risk evaluation.
Risk control process is the analysis through which decisions are reached and protective measures are implemented for reducing risks, or maintaining risks within, specified levels, and must be prepared and maintained by the manufacturer.
Risk evaluation shows the judgement, based onrisk analysis, of whether a risk which is acceptable has been achieved in a given context based on the current values of the intended use.
Risk management is the systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, and controlling risk.
Risk management file is the formal set of records and other documents, not necessarily contiguous, that are produced by a risk management process by the manufacturer.

The IEC/EN standard identifies three classes of ME equipment and ME systems:

Class I Devices
Class I devices are considered to be at the lowest level of risk of all medical devices and are therefore required to comply with the lowest level of regulatory control.

Class II Devices
Class II devices are simple devices, though they are more complicated than Class I devices. They are also considered to be at slightly higher risk than Class I devices and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety.

Class III Devices
Class III devices are generally considered to be the most complex devices. They are also considered to be at the highest risk and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety.

Please contact FDA 510(k) Consultants at IngenesTM to determine how best to classify your equipment or system, and how best to address the risks involved with it for FDA’s regulatory compliance.