CSA - SPE-3000-19
Model Code for the field evaluation of medical electrical equipment and systems
|Publication Date:||1 April 2019|
This Model Code applies to the safety of medical electrical equipment (MEE) and medical electrical systems (MES) as it pertains to protection from electrical shock, and fire and mechanical hazards. It provides construction, marking, and test requirements for the field evaluation of MEE and MES by a field evaluation body accredited by the SCC and/or recognized by the regulatory authority.
Equipment and systems may be evaluated at a client's facilities or at other specified locations, including the location of equipment installation.
If a clause or subclause is specifically intended to be applicable to MEE only, or to MES only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEE and MES, as relevant.
Hazards inherent in the intended physiological function of MEE and MES within the scope of this Model Code are not covered in this Model Code.
Field-evaluated equipment found to be in conformity with the requirements of this Model Code and bearing the appropriate label of the field evaluation body is considered to be acceptable to the authority having jurisdiction (AHJ).
Notwithstanding of Clauses 1.1 and 1.2, field evaluation is not intended to serve as a substitute for certification.
The following are scenarios in which this Model Code applies:
a) custom-built equipment for special applications;
b) equipment manufactured on a non-repetitive basis;
c) equipment sold in quantities of not more than 500 on a national basis, per model, per year, per field evaluation body;
d) equipment not obtainable as "certified" under a regular certification program;
e) equipment already installed or ready for use on site and awaiting acceptance by the AHJ;
f) complete systems that are all available for examination and testing during the evaluation process; and
g) other equipment as determined by the AHJ.
Note: Where it is unclear or there is uncertainty as to whether the equipment is to be field evaluated under the classifications of this Clause, the AHJ should be consulted for clarification.
This Model Code applies where the requirements are supplemented by requirements of particular equipment Standards, where referenced, and the installation requirements of the Canadian Electrical Code, Part I, and the CAN/CSA-C22.2 No. 60601 series of Standards as applicable.
This Model Code is not intended to apply to the re-evaluation of equipment that has been rejected due to the results of a previous evaluation conducted by a certification organization through any other existing certification service.
In this Model Code, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with this Model Code; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of this Model Code.
Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.
Notes to tables and figures are considered part of the table or figure and may be written as requirements.
Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.
In accordance with Clause 1.7, this Model Code has been written in mandatory language to facilitate its adoption where users of the Model Code or regulatory authority wish to do so.