P
Due to a CE Mark application request, my company is performing a testing protocol to demonstrate compliance to EN 1618 (Catheters other than intravascular catheters - Test methods for common properties). There is confusion regarding the interpretation of a few Annexes of this standard. Any Annex dealing with a pressure test contains a Note: "The test pressure is specified in the relevant product standard." There is no relevant product standard that we are aware of for Epidural or Spinal Catheter systems. Can anybody help us figure out what the appropriate pressure is? Or is it somethign that we should just rationally assign a justifiable value to?
Thank you!
Thank you!
