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Model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES)
This is the second edition of CSA SPE-3000, Model Code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES). It supersedes the previous edition, published in 2015 as Model code for the field evaluation of medical electrical equipment and systems, that was referenced by the Standards Council of Canada in its terms of accreditation for field evaluation bodies. However, at the time of publication, 4 specific types of medical equipment were excluded from SPE-3000. The second edition will include the following medical equipment that was previously excluded
This Model Code addresses the minimum requirements for MEE and MES as they pertain to safety. Where other authorities have jurisdiction, they must be consulted by the equipment owner or the owner's agent as to conformance to specific legislation. This legislation may be federal, provincial, or municipal. This Model Code addresses the essential construction, marking, and test requirements that MEE and MES must meet before they can be labelled. It allows for the evaluation of MEE and MES, with the objective of minimizing the risk of degrading the safety of the equipment or system through the procedures used in the field evaluation. The requirements contained in this Model Code are based on the applicable requirements of SPE-1000 and selected requirements of CAN/CSA-C22.2 No. 60601-1. Where the required tests involve procedures deemed to present a hazard to the safety of the particular equipment, such tests may be carried out on a separate representative sample supplied for the sole purpose of testing. Alternatively, other means may be taken to determine conformance, such as the evaluation of relevant test data presented in support of an application for field evaluation. Due to alternative evaluation criteria contained in IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, Edition 3 and Edition 3.1, MEE and MES constructed to that standard may not pass certain tests within this Model Code. The requirements of this Model Code have been accepted by the authorities having jurisdiction (AHJ). It is within the purview of the AHJ in whose jurisdiction the Model Code is applied to add technical or administrative stipulations to or deviations from the Model Code as deemed necessary
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
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.
| SDO | CSA: Canadian Standards Association |
| Document Number | |
| Publication Date | Jan. 1, 2019 |
| Language | en - English |
| Page Count | 96 |
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