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EtO Steriliser Software (PACS) Update Validation Requirements

X

X.Liu

#1
#1
Hi, everyone,
I am new here and would like to get some help. If this is not the right section, please let me know.

I am asking a question of EtO sterilisation validation
When update a control software (PACS) of EtO sterilizer, what kind of stanrdard we would expect supplier to follow and ceritify against?

In the past, I worked on ME equipment, so the software validation was following 60601-1-4. But I am not sure about EtO steriliser.

Thanks!
 
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C

c.mitch

Quite Involved in Discussions
#4
#4
Hello,
The FDA edited a guidance about software: general principles of sftware validation (GPSV). Get it free on FDa website.

I would also suggest IEC 62304 standard. It's the main one about medical software and it is recognized both by FDA and CE mark. This standard is quoted in iec 60601-1 3rd edition about software validation.

Regards.
Mitch.
 
X

X.Liu

#6
#6
We received a validation certificate from software supplier stating their software is evaluated and validated in according to EN 62304......
 
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