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What is your Sterile Medical Device Pouch Peel Strength Spec?

D

d.conroy

#1
I've started in a new company and they use a pouch peel strengths test spec of spec of 50N/15mm (50gf) or 70N/25mm (70gf). (Tested to ASTM F88).
Sterile medical devices, that use all kinds of sheet materials: Tyvek, coated paper, clear film and heavy PE.

All my experience is with the spec of 1.2N/15mm as stated in EN 868-5

I'm wondering is this acceptable of what do other companies use?
 
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shimonv

Trusted Information Resource
#2
I've seen other companies use 1.2N/15mm. It is the minimum seal strength according to EN 868-5.

ASTM F88/F88M-15 is FDA recognized standard. If you are selling in the US you should consider its content.

-Shimon
 
F

frank

#4
Any idea what went into developing the EN 868-5 spec? Is it human factors-based or was some research done on the seal strength necessary for pressure fluctuations in different sterilization cycles?
 
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