EN 1618 Clarification Re: Catheter Pressure Testing

P

phfrasier

#1
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!
 
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S

SteveK

#2
It may be referring to another catheter standard e.g.

In ISO 8836 "Suction catheters for use in the respiratory tract" there is a reference to pressure for test purposes i.e.:

7.2 Shaft

When the machine end of the suction catheter is connected to a vacuum source at 40 kPa (408 cmH2O) below ambient pressure for 15 s at a temperature of (23?2) ?C with the patent end occluded and, if present, the vacuum control device occluded, the shaft shall not collapse.

Don't know if this helps

Steve
 
P

phfrasier

#3
Thank you Steve. We've looked and cannot find any specific standards relating to Epidural/Spinal Catheters and associated pressures.

Are you, or is anybody else aware of any such standards?

And if no standards exist, it seems that it would be reasonable to rationalize a pressure based on those experienced during actual product use, doesn't it?

:thanks:
 
S

SteveK

#4
Found this current British Standard at:

http://shop.bsigroup.com/en/ProductDetail/?pid=000000000000197243

BS 6196:1989 "Specification for sterile epidural catheters and introducer needles for single use "

Do not know what is in it wrt testing, though the descritors indicate:

Catheters, Medical equipment, Medical instruments, Injection instruments, Tubing (medical), Sterile equipment, Disposable, Packaging, Marking, Size, Numerical designations, Strength of materials, Graduations, Marks, Design, Testing conditions, Corrosion tests, Tensile testing, Mechanical testing, Symbols, Cannulas, Anaesthetic equipment

Steve
 
P

phfrasier

#5
Thank you Steve. Yes, we have that on file and there are a number of tests (none which do not already appear in EN 1618 actually), but there are no tests for pressure.

Looks like we'll justify a pressure of our own, while noting that there are no associated standards which specify a pressure.

Thank you for your help!
 
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