Transport validation to different climate zones

Ronen E

Problem Solver
Staff member
Moderator
#11
that should work, right?
It wouldn't be serious of me to devote 10 minutes and deliver a yes/no answer. I thought that my previous posts explained why.
This is a specialised engineering work packet. If you're interested in working through it, please PM me. Otherwise, you seem capable, and already have directions pointed out in this thread.
 
Elsmar Forum Sponsor
#12
Hello, I have a question that if disposable gown and drape (made only from fabric) need ISTA testing? Our CE auditor request this to us. Our product is class 1s (made only from sms fabric), ETO sterile.
 

planB

Trusted Information Resource
#13
kyqunagtien,

you may want to demonstrate compliance to ISO 11607-1:2019, since you have a terminally sterilised product. According, this standard, section 8.2 "The packaging system shall provide adequate protection to all sterile barrier systems and the sterile contents through the hazards of handling, distribution and storage."

In case you have adequate existing data at hand (e.g. from comparable packaged predicate devices) you may fulfill this requirement without generating new test data. Otherwise, ISO 11607-1, Annex B, table B.1, section "Performance testing" provides you with a list of recommended standardised test methods, ISTA methods being one optional approach for performance testing.

HTH,
 

indubioush

Quite Involved in Discussions
#14
I have always followed ASTM D4332 − 14 (Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing) and
D4169 − 16 (Standard Practice for Performance Testing of Shipping Containers and Systems).
 
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