ISO 11607-1 for surgical instruments sterilized by end user

#1
Hi all,

Is ISO 11607-1 standard applicable for a (single use) surgical instrument that is provided non-sterile to the customer? Prior to use during surgery, the instrument is to be cleaned and sterilized at the hospital according to the instructions provided in the instructions for use (IFU).

I am under the impression that this ISO 11607-1 standard is not applicable since we provide the surgical instrument in non-sterile packaging to the hospital, the instrument is taken out of its packaging at the hospital, processed and repackaged for steam sterilization.
Feedback from our NB indicates that they believe ISO 11607-1 is applicable.

The only thing I can imagine is to add to the IFU that pouches or wraps compliant with ISO 11607-1 should be used at the hospital.

Is this sufficient in your opinion? How do other manufactures of similar medical devices that are provided non-sterile this?

Thx
 
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#2
BioCPS,

in case you label "terminal" steam sterilisation, i.e. sterilisation in some kind of sterile barrier system, then , yes, your NB is right: ISO 11607-1:2019 applies - quote from ISO 11607-1:2019, section 1, Scope:

[ISO11607-1] is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
Your suggestion, to add to the IFU that pouches or wraps compliant with ISO 11607-1 should be used at the hospital, seems reasonable and sufficient to me.

HTH,

Gerhard
 
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