What does sterilization validation require under ISO 11135, 11137 and 17665?
What is this resource?
An overview of sterilization validation documentation and support spanning the major sterilization modalities and the sterile barrier system standard.
Who should use it?
Manufacturers of sterile devices and their quality and regulatory teams responsible for sterilization validation and its regulatory acceptance.
When should it be used?
When validating or revalidating a sterilization process, when preparing sterilization evidence for a Notified Body or MDSAP audit, or when aligning sterile barrier documentation to ISO 11607.
What does it include?
- EO, radiation, and moist heat validation coverage
- Sterile barrier system alignment to ISO 11607
- Regulatory alignment across FDA, EU MDR, MDSAP, ISO 13485
Need more than a template?
SA Quality Solutions provides implementation support, gap assessments, internal audits, and remediation services for FDA QMSR, ISO 13485, MDSAP, and EU MDR. If you would rather have this done with you than do it yourself, a 30-minute discovery call is available at no cost.
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