Contract Sterilization Service Providers

chris1price

Trusted Information Resource
#1
Hi,

Is there a regulatory requirement or industry standard for contract sterilisers (EtO, Gamma, etc) to be certified to ISO13485 or is it just common practice?
 
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shimonv

Trusted Information Resource
#2
Contract sterilisers must comply will the applicable standard for the service they provide, e.g. ISO 11135 for EyO sterilisation, and the general standard for QMS - ISO 13485. You can have a look at websites for contract sterilisers for benchmarking.
 

chris1price

Trusted Information Resource
#4
Thanks guys, yes, the contract steriliser should comply with ISO1135 or ISO11137, but you don't get certified directly to those standards. Its usually within the scope of the QMS. So could a sterilisation contractor be certified to ISO9001 or does it have to be ISO13485?
 

shimonv

Trusted Information Resource
#5
I see... since compliance to ISO standard is voluntary I don't think you have to comply with ISO 13485 but it does look better with potential clients.
 

Philip B

Involved In Discussions
#6
I think it is common practice for any that sterilise medical devices to have 13485 but I don't think it is mandatory (same as for manufacturers).
 
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