CSA SPE-3000:19 pdf download – Model Code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES).
Accompanying document — a document accompanying equipment or an accessory and containing important information for the responsible organization, operator, or service personnel, particularly regarding safety.
Appliance coupler — means enabling the connection of a flexible cord to electrical equipment without the use of a tool, consisting of two parts: a mains connector and an appliance inlet.
Appliance inlet — part of an appliance coupler, either integrated into or fixed to equipment.
Applicable standard — standard of design, construction, testing, and marking that is
a) applied to electrical equipment by persons or associations who inspect, test, and report upon electrical equipment; and
b) intended to prevent exposure of persons and property to undue hazards.
Applied part — part of MEE that in normal use necessarily comes into physical contact with the patient for MEE or an MES to perform its function.
Applied part leakage current — current flowing from mains parts and the accessible conductive parts of the enclosure to the applied parts.
Approved (as applied to equipment and components) —
a) equipment that has been certified by a certification organization accredited by the Standards Council of Canada in accordance with the requirements of
i) CSA Group standards; or
ii) other standards that have been developed by a standards development organization
accredited by the Standards Council of Canada, or other recognized documents, where CSA
Group standards do not exist or are not applicable, provided that such other standards or
other recognized documents
1) are correlated with provisions of the Canadian Electrical Code, Part I; and
2) do not create duplication with standards listed in Appendix A; or
b) equipment that conforms to the requirements of the regulatory authority (see Appendix B).
Notes:
1) This Is the Canadian Electrical Code, Part I definition.
2) Item b) covers field-evaluated equipment.
3) Items a) and b) apply only to electrical equipment.
Authority having Jurisdiction (AHJ) — the organization, office, or person authorized to determine which electrical equipment, appliance, or device may be installed, used, or sold within their area of jurisdiction.
Basic insulation — insulation providing basic protection against electric shock.
Certification body — an organization accredited by the Standards Council of Canada to certify equipment, components, or installations in accordance with its scope of accreditation, and that is recognized by the AHJ.
Class I — a term referring to electrical equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in that means are provided for accessible parts of metal or internal parts of metal to be protectively earthed (see Figure 2).
Continuous operation – operation under normal load for an unlimited period of time without the specified limits of temperature being exceeded. Defibillation-proof applied part – an applied part that is protected against the effects of a discharge of a cardiac defibrillator to the patient. Detachable power supply cord – a flexible cord intended to be connected to electrical equipment by means of a suitable appliance coupler for mains supply purposes. Direct cardiac application – use of applied part that can come in direct contact with the patient’s heart. Double insulation – – insulation comprising both basic insulation and supplementary insulation. Duty cycle – the maximum activation (on) time followed by minimum deactivation (off) time necessary for the safe operation of the MEE. Earth leakage current – the current flowing from the mains part through or across the insulation into the protective earth conductor. Enclosure – exterior surface of electrical equipment or parts thereof. Enclosure leakage current – the current flowing from an enclosure or from parts thereof, excluding an applied part, accessible to the operator or patient in normal use, through an external conductive connection other than the grounding conductor to earth or to another part of the enclosure. Equipment leakage current – the current flowing from mains parts to earth via the protective earth conductor and accessible conductive parts of the enclosure and applied parts. F-type isolated (floating) applied part (F-type applied part) – an applied part in which the patient connections are isolated from other parts of the equipment to such a degree that no current higher than the allowable patient leakage current flows if an unintended voltage originating from an external source is connected to the patient, and thereby applied between the patient connection and earth. Note: F-type applied parts are either Type BF applied parts or Type CF applied parts.CSA SPE-3000:19 pdf download.
