Understanding requirements of SPE 3000 model code
September 21, 2016
VANCOUVER – The overall purpose of CSA establishing a model code around the field evaluation of Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES) is to address the safety of those devices from hazards such as electric shock, fire, and mechanical hazards, and the risks that they pose. It is for these reasons that SPE 3000 was instituted, to identify the potential for those types of hazards and take corrective measures to address them.
To assess each of these potential risks, the SPE 3000 model code puts in place requirements for the construction, marking, and testing of MEE and MES. Construction requirements range from basic conditions such as stating that MEE and MES do not have sharp edges and points, to more complex requirements specific to motors, transformers and batteries.
The marking requirements are aimed at providing the pertinent information related to a particular device such as the manufacturers name and trademark, the supply voltage and frequency for the equipment, as well as horsepower ratings for equipment that contains a motor. Marking requirements also include the required caution markings (in English and French for the Canadian Market).
SPE 3000’s testing requirements, as stated, are aimed at assessing the equipment’s safety against hazards that would pose a danger to patients. For instance, testing requirements like dielectric voltage withstand testing and leakage current testing analyze the effectiveness of the protection against electric shock, while input rating testing is conducted to confirm that the measured input of MEE or MES at rated voltage does not exceed the marked rating by more than 10%.
Going further, the code mandates that protocols such as flame testing are undertaken to test the overall flammability of the equipment’s polymeric enclosure, and a strain relief test is conducted to test the durability of the device’s strain relief mechanism, to ensure that power cord cannot be displaced within the device, which could result in a hazard.
These in-depth testing procedures provide a comprehensive analysis and assessment of the overall safety and performance of a device and its compliance with the model code, and demonstrate the commitment of SPE 3000 towards ensuring that the proper measures have been taken towards ensuring that MEE and MES provide the appropriate level of safety for patient use.
The implementation of SPE 3000 emphasizes the need for all equipment and systems to undergo rigorous testing procedures to provide assurance to those in the medical community and their patients, that all devices that they come in contact with will provide protection against electrical shock, fire and mechanical hazards.
Intertek’s experience and expertise in both the medical and electrical fields serve as an invaluable resource towards ensuring that the devices in your offices and hospitals are in compliance with the requirements of SPE 3000. The establishment of this model code has allowed Intertek to expand its capabilities to now include field approval for MEE and MES among its broad service offering for the medical industry.
This is the second in a series of articles on CSA SPE-3000 which will serve to inform the medical community on this new model code, its requirements and what it means for medical electrical equipment.
Simon Knight is Products Manager – Canada. He is responsible for Intertek’s Building & Construction and Electrical testing, inspection and field service businesses in Canada. Intertek has laboratories in Edmonton, Winnipeg, Montreal, Toronto and Vancouver. He has been with Intertek for six years and is based in Vancouver.