Helloo everyone.
I have received an attestation form from Health Canada for signoff and return. along with some information about the DEHP not exceeding 0.1% in the plastic parts (PVC) and similarly not being a derivative from BPA in the medical devices we make.
We make patient monitors and sensor cables which have plastic parts in them. These are supplied from various vendors.
Can anyone here with Health Canada experience about this aspect throw more light about what tests were conducted and how this 0.1% was confirmed before attesting and returning this form to Medical devices bureau. Not being an expert in chemicals and plastics, I am stuck ....
I have received an attestation form from Health Canada for signoff and return. along with some information about the DEHP not exceeding 0.1% in the plastic parts (PVC) and similarly not being a derivative from BPA in the medical devices we make.
We make patient monitors and sensor cables which have plastic parts in them. These are supplied from various vendors.
Can anyone here with Health Canada experience about this aspect throw more light about what tests were conducted and how this 0.1% was confirmed before attesting and returning this form to Medical devices bureau. Not being an expert in chemicals and plastics, I am stuck ....


