CSA Group Code modèle pour l'évaluation à pied d'oeuvre de l'appareillage et des systèmes électromédicaux SPE-3000-F15

Preface This document is the first edition of the CSA SPE-3000 model code, a model code for the on-site evaluation of equipment and electromedical systems. The on-site evaluation of medical electrical equipment (MEA) and electro-medical (EM) systems in accordance with this model code should only be carried out by qualified persons with all the necessary skills. These individuals should have at least five years of experience in the field assessment and field testing of electrical and electronic equipment, or three years of experience in testing and certification of electromedical devices and systems in accordance with Canadian standards or other equivalent standards recognized internationally or nationally. Because the on-site evaluation of MEAs and SEMs is done in accordance with this model code, it is not the equivalent of an assessment conducted for certification, which is performed according to the relevant standard . As a result, equipment and products that are subject to on-site evaluation and are allowed to bear the relevant label can not be considered certified. On-site evaluation of electrical equipment based on the requirements of this model code must be performed by an inspection organization accredited by the Standards Council of Canada (SCC). The accreditation of an inspection body is the process of evaluating and publicly recognizing the integrity, reliability and technical competence of an organization's inspection services. Accreditation of an organization's inspection services by SCC is a means of demonstrating that these services (within the limits of their official accreditation) comply with a set of accepted requirements. This model code addresses the minimum requirements for MEAs and SEMs with respect to safety. If other authorities are competent, they must be consulted by the equipment owner or his representative to know the applicable regulations. These regulations may be federal, provincial or municipal. This model code outlines the construction, marking and testing requirements that MEAs and SEMs must meet to be labeled. It aims to ensure, as far as possible, that the on-site evaluation methods of MEAs and SEMs will not adversely affect the safety of the equipment. The requirements in this model code are based on the relevant requirements of the SPE-1000 and certain requirements of CAN / CSA-C22.2 No. 60601-1 and IEC 62353. If the required tests are likely to adversely affect the safety of an apparatus, these tests may be performed on a sample provided exclusively for testing purposes. Alternatively, other means may be used to establish compliance, including the evaluation of relevant test data submitted in support of a field assessment application. Due to the use of different evaluation criteria in editions 3 and 3.1 of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, it is possible that the MEAs and SEM manufactured in accordance with IEC 60601-1 do not meet the requirements of certain tests of this model code. The requirements of this model code have been accepted by the competent authorities. The competent authority of the province or territory where the model code is applied may add technical or administrative requirements to the model code or permit derogations from it if it deems it necessary. Although the primary purpose of this model code is stated under its Scope of Application, it is important to remember that the onus is on the user to judge whether the model code is appropriate for their particular needs. Introduction 0.1 The purpose of this model code is to facilitate the safety assessment of medical electrical equipment (MEA) and electro-medical (EM) systems based on safety aspects other than the requirements for risk analysis. evaluation of the effectiveness or operation of the products. Field of application 1.1 This model code applies to the safety of medical electrical equipment (MEA) and electro-medical (EM) systems with respect to the hazards of electric shock, fire and mechanical hazards. It sets out construction, marking and testing requirements for the on-site evaluation of MEAs and SEMs by a SCC-accredited on-site assessment organization and / or ) recognized by the regulatory authority. Devices and systems may be evaluated at a customer's facility or other specified locations, including the location where the devices or systems are installed. If an article or a paragraph is specifically applicable only to MEAs or SEM only, that restricted application will be made explicit in the title and content of the article or paragraph, failing which the article or paragraph applies both the MEA and SEM, as the case may be. The hazards inherent in the expected physiological function of MEAs or SEMs within the scope of this model code are not covered by this model code. 1.2 Any equipment evaluated on site that meets the requirements of this model code and that bears the appropriate rating of the field assessment agency shall be considered acceptable to the appropriate authority. 1.3 Notwithstanding Articles 1.1 and 1.2, on-the-job evaluation does not replace certification. 1.4 This model code applies to the following types of apparatus: a) non-standard equipment for a particular purpose (b) equipment manufactured in small quantities (c) equipment, of which not more than 500 copies shall be offered for sale at the national level, by model, by year, by field assessment agency (d) equipment that can not be "certified" as part of a normal certification program (e) equipment already installed or ready for use on the site and awaiting acceptance by the competent authority f) complete systems ready for review and testing during the evaluation process Note: If it is not clear or certain that the equipment can be evaluated on-site under this article, the competent authority should be consulted. 1.5 This model code applies if its requirements are supplemented by those of a particular standard referenced by the Canadian Electrical Code Installation Requirements, Part 1 and the requirements of the relevant CAN series standards. /CSA-C22.2 No. 60601, as the case may be. 1.6 This model code does not apply to the re-evaluation of equipment that was rejected in a previous assessment by a certification body under another existing certification service. 1.7 In this model code, the word "must" indicates a requirement, ie a requirement that the user must comply with to ensure compliance with the model code; "Should" indicates a recommendation or what it is advised but not required to do; and "may" indicates a possibility or what is permitted. The notes accompanying the articles do not include prescriptions or recommendations. They serve to separate from the text explanations or information that is not properly part of the model code. The notes at the bottom of the figures and tables are part of these and may be written as prescriptions. The annexes are qualified as normative (mandatory) or informative (optional) to specify its application. 1.8 In accordance with Article 1.7, this model code is drafted in a normative style to facilitate adoption by users or regulators wishing to do so.