New requirements for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES) as spelled out in CSA SPE-3000-19, issued on April 2019.

Bulletin date:
Bulletin number:
2020-01

Action required

All SPE-3000 accredited Inspection Bodies (IBs) are formally required to transition to the new April 2019 version of SPE-3000 by July 31st, 2020.

 

IBs will submit updated documentation, undergo knowledge interviews and provide witness audits as part of SCC’s assessment of successful transition.

 

SPE-3000-19 may be used immediately for inspections if an IB has transitioned to the new edition of the code and maintains recorded evidence, however no IB shall inspect equipment on the exclusion list until an updated scope has been posted by SCC. 

 

Affected customers

Inspection bodies accredited to IBAP, auditors, and assessors in the area of field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES) (SPE-3000). 

 

Background

CSA Group has issued the second edition of CSA SPE-3000 Model Code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES), which supersedes the previous edition published in 2015.

 

When the first edition of SPE-3000 was published in 2015, 4 specific types of medical equipment were excluded from SPE-3000 code. This second edition now includes the medical equipment previously excluded:

  • Cosmetic and hygiene equipment;
  • X-ray equipment and systems;
  • Magnetic resonance imaging and computerized tomography scanning equipment; and
  • Laser and devices incorporating lasers.

 

New requirements

In order to transition to the new code, all Inspection Bodies accredited for SPE-3000 need to be assessed remotely or on-site and obtain the new scope by the transition deadline.  Following the deadline, no IBs will be permitted SPE-3000 exceptions on their scope.

 

As a part of the assessment, the following will be required:

  • Evidence of updates to the management system covering the required modifications
  • Updated inspection form and/or report
  • Up-to-date qualification/authorization matrix
  • Training of appropriate personnel in the new equipment included in the new edition of SPE-3000.

  • Knowledge interviews with inspectors will be performed by SCC technical experts during the assessment.

     

Note: Witness audit requirements as listed in the Program Overview Guide must still be met.

 

Deadline

To successfully fully transition to SPE-3000-19, IBs shall:

  • Submit requested documentation to SCC by March 31st, 2020.
  • Participate in interviews with SCC’s assessment personnel, including knowledge interviews with the IB’s inspectors.
  • Ensure all the nonconformities (if applicable) are closed. 

 

IBs that successfully complete the required steps for this transition – a) to c) -  will have their new scope of accreditation published on July 31st, 2020 at the earliest.

 

IBs not meeting this transition will have SPE-3000 removed from their scope as of July 31st, 2020.

 

Questions?

Please contact Abdel Kassou, Manager, Compliance and Assessment Services, Accreditation Services, at abdel.kassou@scc-ccn.ca or +1 613 238 3222 for more information.