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.
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.
Please contact us for further information about our Electrical Safety testing services. We may be able to assist you to get this done for you at a significantly lower cost.
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