C
All,
I have been doing a little research and I would like to get some input from other sources. I am looking for some cleanliness specifications or standards that apply to non-sterile medical devices.
We manufacture medical devices and distribute them sterile and non-sterile. I certainly understand that there are several specs and standards regarding sterility levels (SAL, Dose Audits, VDmax, etc) but I am more concerned with non-sterile. We also provide Instructions for Use that clearly state how to sterilize products at the hospital (steam sterilization) when provided non-sterile.
However, we are trying to justify / specify non-sterile cleanliness standards (Particulate Counts, Cytotoxity levels, Total Organic Carbon, etc) and there appears to be no available standards. Basically I am finding that we as a company should pick our own specifications and have some justifcation as to why. Then we need to validate our cleaning process achieves those defined standards.
Is this accurate? Are there available (non-sterile) cleanliness standards for implants (class 2 devices) or instruments? If not, are their industry standard levels that are generally accepted? Or any levels you are willing to share (or have seen in the past)? I am assuming some of this information would be confidential to your company, so I certainly don't want you to give any information you shouldn't.
Sorry for the length of this post, but I am looking for something specific that my searching has not come up with.
Thanks,
Casey
I have been doing a little research and I would like to get some input from other sources. I am looking for some cleanliness specifications or standards that apply to non-sterile medical devices.
We manufacture medical devices and distribute them sterile and non-sterile. I certainly understand that there are several specs and standards regarding sterility levels (SAL, Dose Audits, VDmax, etc) but I am more concerned with non-sterile. We also provide Instructions for Use that clearly state how to sterilize products at the hospital (steam sterilization) when provided non-sterile.
However, we are trying to justify / specify non-sterile cleanliness standards (Particulate Counts, Cytotoxity levels, Total Organic Carbon, etc) and there appears to be no available standards. Basically I am finding that we as a company should pick our own specifications and have some justifcation as to why. Then we need to validate our cleaning process achieves those defined standards.
Is this accurate? Are there available (non-sterile) cleanliness standards for implants (class 2 devices) or instruments? If not, are their industry standard levels that are generally accepted? Or any levels you are willing to share (or have seen in the past)? I am assuming some of this information would be confidential to your company, so I certainly don't want you to give any information you shouldn't.
Sorry for the length of this post, but I am looking for something specific that my searching has not come up with.
Thanks,
Casey