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.
SCC wants to outline the transition requirements for the labels that will be applied by those accredited IBs beginning July 1st, 2016 The requirements are:
- If an IB has printed labels in hand that conform to SPE-3000-15, it is permissible to use these labels from July 1st, 2016 until July 1st, 2017 or until the labels are consumed, whichever comes first.
- At such time, the IB shall update the label as defined in the SPE-3000-15/Cor 1-16. The IB shall inform SCC of this transition to the new label sufficiently in advance to permit SCC to change the scope of accreditation and to indicate the terms of both the old and new labels.
- Alternatively, an IB may choose to discard the labels in hand conforming to SPE-3000-15 and use labels that conform to SPE-3000-15/Cor 1-16.
- If an IB does not yet have any labels in hand, it is required by SCC that the IB shall use labels that conform to SPE-3000-15/Cor 1-16.
- All labels used by SCC accredited IBs for the SPE-3000 program shall conform directly to either SPE-3000-15 or SPE-3000-15/Cor 1-16.
- After July 1st, 2017 all applied labels shall conform to SPE-3000-15/Cor 1-16.
Please inform the appropriate SCC Account Manager of the action that will be taken by 2016-07-04. If a change to the artwork is occurring, this updated artwork shall be provided to SCC immediately to ensure the SCC scope of accreditation is updated in a timely manner.
If you have any questions, please contact Rassoulou Diallo, Manager, Technical Services at email@example.com or +1 613 238 3222 ext. 437.