The standards delineated in IEC 60601 have established a broadly accepted benchmark for medical electrical equipment. IEC 60601-1 outlines the general standards expected to be met by all medical electrical equipment, while IEC 60601-2 provides particular standards which apply to specific types of medical electrical equipment.
IEC 60601-1 is continually reviewed, and standards may be added or changed through amendments. It is considered mandatory for most markets, including the EU, the US, and Canada to show evidence of safety and performance. It does not establish standards for effectiveness, but individual markets mandate a certain level of effectiveness in addition to the requirements of IEC 60601.
The IEC 60601 standards perform important functions for assuring safety and performance of medical electrical devices:
IEC 60601 describes two types of standards – general in IEC 60601-1 and particular in IEC 60601-2.
IEC 60601-1 outlines the general safety and performance requirements of all medical electrical devices. Additional collateral standards in IEC 60601-1 are described in 12 parts and include topics such as environmentally conscious design and radiation protection. Each of the parts of IEC 60601-1 outlines a minimum standard for all medical electrical equipment.
The particular standards in IEC 60601-2, however, address minimum requirements for specific medical electrical equipment. For example, IEC 60601-2-4 applies to cardiac defibrillators and IEC 60601-2-19 applies to infant incubators.
IEC 60601 is mandatory in the US, Canada, and the EU. In the US, it applies only to new devices, where in the EU all medical devices must adhere to collateral standard IEC 60601-1-11, regarding electrical devices used in the home healthcare environment.
In addition to IEC 60601, each market has other regulations for approval of medical electrical devices. For example, in the US, FDA requires proof of effectiveness in addition to the safety and performance standards found in IEC 60601.
Compliance with IEC 60601 is not an optional task for medical device manufacturers who hope to bring a medical device to market, whether in the US, Canada, or the EU.
Greenlight Guru's medical device QMS software is the right choice for medical device manufacturers that want to easily manage the approval process for IEC 60601. The process can be drawn out due to numerous steps and documents, and Greenlight Guru provides one place for the organization so they are secure and accessible by the appropriate team members. This level of organization simplifies compliance with requirements for medical electrical devices, including IEC 60601, expediting approval and overall time to market.
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