CSA SPE-3000-15

Preface

This is the first edition of CSA Model Code SPE-3000, Model Code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES).

Field evaluation of MEE and MES in accordance with this Model Code should be undertaken only by fully qualified and competent persons. These persons should have at least five years of experience in conducting field evaluation and field testing of electrical/electronic equipment, or three years of experience in testing and certification of medical electrical equipment and systems to Canadian standards or other equivalent nationally or internationally recognized standards.

Because field evaluation of MEE and MES is conducted to the requirements of this Model Code, it is not equivalent to an evaluation in support of certification, which is conducted to the requirements of the applicable product standard. Consequently, equipment and products that are field evaluated and labelled cannot be claimed to be certified.

Field evaluation of electrical equipment in accordance with the requirements of this Model Code is intended to be conducted by an inspection body accredited by Standards Council of Canada (SCC). Inspection body accreditation is the process of assessing and publicly recognizing the integrity, reliability, and technical competence of an organization's inspection services. Accreditation of an organization's inspection services by the SCC is a means of demonstrating that those services (within the scope of their formal accreditation) conform to an accepted set of requirements.

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 either federal, provincial, or municipal.

This Model Code addresses the essential construction, marking, and test requirements that MEE and MES must meet before it 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 and IEC 62353.

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 those standards may not pass certain tests within this Model Code. The requirements of this Model Code have been accepted by the authorities having jurisdiction (AHJs). 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 was developed by the Canadian Advisory Council on Electrical Safety (CACES) Subcommittee on SPE-3000 and was approved by CACES. Although the intended primary application of 7this Model Code is stated in its Scope, it is important to note that it remains the responsibility of the users of the Model Code to judge its suitability for their particular purpose.

Introduction

0.1
The object of this Model Code is to facilitate a safety evaluation of medical electrical equipment (MEE) and medical electrical systems (MES) to safety considerations that does not include requirements pertaining to risk analysis, evaluation of efficacy, or performance of products.

Scope

1.1
This Model Code applies to the safety of medical electrical equipment (MEE) and medical electrical systems (MES) as it pertains to safety 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.

1.2
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 AHJ.

1.3
Notwithstanding the requirements of Clauses 1.1 and 1.2, field evaluation is not intended to serve as a substitute for certification.

1.4
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; and

f) complete systems that are all available for examination and testing during the evaluation process.

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.

1.5
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.

1.6
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.

1.7
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.

1.8
In accordance with Clause 1.7, this Model Code has been written in mandatory