Sterilisation Validation

Required for devices supplied in sterile condition or intended to be sterilised before use.

Applicable standards: ISO 11135 (EtO), ISO 11137 series (radiation), ISO 17665 (steam), ISO 14937 (other methods), ISO 11607 (packaging).

All sterile devices must have a validated sterile barrier system (ISO 11607) including packaging integrity testing, accelerated and real-time aging studies, and distribution simulation. For radiation-sterilised devices, regular dose audits and bioburden testing are required.

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.