For the attention of Standards Council of Canada (SCC) accredited inspection bodies (IB) performing inspections under our Inspection Body Accreditation Program for CSA SPE-3000 Model Code for the field evaluation of medical electrical equipment and systems.

On 2016-06-30, SCC accredited several inspection bodies for field evaluation of products that fall within the scope of SPE-3000, but excluded the product categories listed in clause 4.2.33 of SPE-3000. The excluded product categories are:

a) cosmetic and hygiene equipment;

For the attention of Standards Council of Canada (SCC) accredited inspection bodies (IB) who applied for accreditation under our Inspection Body Accreditation Program for CSA SPE-3000 Model Code for the field evaluation of medical electrical equipment and systems.

On 2016-06-16 Canadian Standards Association (CSA) published an erratum to this model code. This erratum affects the label content as outlined in Annex B.1 of this document. This modified version of the Code is further referred to in this bulletin as SPE-3000-15/Cor 1-16.

For Inspection Body Accreditation Program customers,

SCC has now published the revised Requirements and Guidance - Inspection Body Accreditation Program. This document revision was done to account for the addition of a new sub-program, the accreditation of inspections against CSA Model Code SPE-3000, for Medical Electrical Equipment. However, SCC has used this opportunity to introduce other important changes, all resulting from consultation with its stakeholders:

For customers and stakeholders in SCC’s Inspection Body Accreditation Program (IBAP),

SCC is happy to announce that it is now ready to begin accepting applications for the accreditation of inspections of medical electrical equipment against the CSA Model Code SPE-3000, which was published earlier this year.