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;
b) X-ray equipment and systems;
c) MRIs and CT scans; and,
d) laser equipment.
CACES regulators were consulted at their Annual General Meeting in June 2016 and requested SCC to allow for scope extensions to include these product categories.
SCC has since determined the additional requirements that are applicable for these product categories and plans to move forward.
Those IBs currently accredited to SPE-3000 wishing to add any of the above product categories to their scopes of accreditation shall advise their designated SCC Account Manager and provide the following:
- List of which categories of product from SPE-3000 clause 4.2.33 that it is requesting to add.
- List of the certification standards it will consider to address the safety requirements for each category of product requested.
- List of technical personnel that it will use to cover these product categories.
- Training records for these personnel.
- Competence records for these personnel.
- Procedures related to SPE-3000 if they have changed to accommodate the equipment being added.
- The list of inspections performed within the previous 12 months of the equipment being added (if applicable).
For those SPE-3000 accredited IBs that were recently assessed onsite by SCC, all efforts will be made to process this scope extension without another on-site assessment (e.g. remote assessment). Scope extension application fees will be waived, but any applicable professional fees will still apply.
For all others, such as a new IB applying for accreditation or an existing IB requesting a scope extension for SPE-3000, including these additional categories of equipment, the regular application, professional and assessment fees apply.
If you have any questions, please contact Rassoulou Diallo +1-613-238-3222 ext. 437.