A new safety standard for medical devices
August 17, 2016
MISSISSAUGA, Ont. – This past July, a new model code was put into effect that will bring sweeping changes to the Canadian medical device industry, and it will have an impact on a wide cross-section of industry professionals.
SPE-3000 is the model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES), specifically for devices and systems sold in limited quantities in Canada.
The code specifies construction, marking, and testing requirements for such products with the aim of mitigating any risks for electric shock, fire and mechanical hazards.
Under SPE 3000, field evaluation must be conducted by a field evaluation body which is accredited by the SCC and/or recognized by the regulatory authority.
The origins of SPE 3000 can be found in SPE 1000, which first established a model code for the field evaluation of electrical equipment. Situations in which SPE 3000 code would apply include custom-built equipment used for special applications, equipment which is manufactured on a non-repetitive basis, or equipment not obtainable as “certified” under a regular certification program.
Equipment sold in quantities of not more than 500 on a national basis, per model, per year, and per evaluation body would also be classified under SPE 3000. There are provincial deviations that may apply to the quantities and it is recommended that users check this prior to selling into each province.
Where SPE 3000 is not intended to apply is in the re-evaluation of equipment that has been rejected based on the results of a previous evaluation which was conducted by a certification organization through any other existing certification service.
It also currently cannot be used to evaluate cosmetic and hygiene equipment, X-ray equipment and systems, MRIs, CT scans or laser equipment. Additionally, any hazards inherent in the intended physiological function of MEE and MES within the scope of the code are not covered under SPE 3000.
The code will have far-reaching implications for many in the medical device industry including doctors, dentists, hospitals, medical clinics, medical distributors and others. It is important for all involved to understand the requirements within SPE 3000, and what is necessary to comply.
As of July 1, 2016, qualified inspection bodies accredited by the SCC are able to conduct field evaluations under the model code. Proactively working towards compliance with SPE 3000 will save time in commissioning of equipment both upon installation or arrival at the end use destination.
The adoption of this new model code has allowed Intertek to expand its capabilities to now offer field approval for manufacturers of MEE and MES sold in Canada for limited quantities. Prior to the establishment of this model code, full certification was the only option Intertek could provide in this area.
As a qualified inspection body, Intertek has the capability to address all SPE 3000 field approval needs, improving speed to market. With its expertise in both electrical and medical devices, working with Intertek keeps you at the forefront of the industry, ensuring that each and every one of your products is always tested to the latest applicable standards.
This is the first 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.