If this EN ISO 11137 certificate acceptable for Contract Sterilization?


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We have a "Contract Sterilizer" to gamma irradiate our medical devices. When I asked him for his ISO 13485 certificate, I saw that their BSI certificate mentions the scope to comply per EN ISO 11137-1:2006.

The EN ISO 11137-1 is just one of the 3 parts of the EN ISO 11137 standard and has 3 parts -

Part 1 - Requirements for development, validation and routine control of a sterilization process for medical devices

Part 2 - Establishing the sterilization dose

Part 3 - Guidance on dosimetric aspects

So if the ISO 13485 certificate has the scope of just ISO 11137-1, would that be construed that Parts 2 and 3 are also covered ?

Or would the scope should have been just EN ISO 11137 and not mention the Parts ?

Thank you !


Re: If this ISO 13485 certificate acceptable?

It's their job to establish and maintain a capable system...QMS and radiation hardware.

It's your job to design, validate and document your sterilization requirement for your particular product(s). You then will give them your spec, and they'll sterilize to that spec.

They might help you, as subject matter experts, but it's your responsibility.

So, they comply with -1, you comply with -1, -2 and -3.
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Great point. That makes sense when they just have certification to ISO 11137-1.

Appreciate your input.
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