ISO 11135:2014 and The QMS

A little more on my answer to the question posed after the EO sterilization webinar:

Ques:  I have a vendor ETO a load for me... what do i need to ensure that they let the load sit or air out between PQ runs?    ISO  11135 or FDA requirement?

Ans:  As mentioned early in the presentation, ISO 11135 presupposes the existence of a viable QMS / CGMP system, as well as adherence to the validation requirements of the standard to complete a successful validation.  Since ISO 11135 is an international standard, it specifically references ISO 13485 requirements under (page 11 of the standard) 4 Quality Management System, 4.1 Documentation, and 4.2 Management Responsibility, and 4.3 Product Realization, et al.   ISO 13485 requires, among others, that a company and its supply chain / vendors adhere to the requirements of 13485 for medical devices.  The US FDA recognizes ISO 11135 as a consensus standard, so for the US, the QSR 21 CFR 820, the CGMPs would be the device QMS in lieu of ISO 13485 (both requirements are very similar).  

So such adherence would assure that your question is addressed.  This can be reaffirmed by a Quality Agreement or Contractual Requirement, verified by Certification / Audit, and/or by other means. 

-- John E. Lincoln     jel@jelincoln.com

A vendor must follow your written requirements/specifications, in this case your validated EO cycle, which also should include a defined minimum aeration time under specified, controlled conditions, all documented, a verified copy of which should be supplied and checked by your QA as part of a sterile load release, all retained in your DHR (lot history).  Since EO gas is a carcinogen, aeration is also a safety requirement.  - JEL, 07/07/25 

The validated aeration time is confirmed by a product's EO residuals data, which have been reviewed and cleared by the FDA as part of a 510(k) clearance or PMA approval. Adherence to a validated sterilization cycle should be clearly stated in the PO, or Contract, or Quality Agreement between the company and the contract sterilizer, and cycle parameters for the lot supplied from the vendor, included with the shipment of sterilized product and checked by the receiving company's QA prior to acceptance at incoming, and prior to final release to the field, and recorded in the DHR for that sterile load, and the individual product lots' DHR's from that sterile load.  - JEL, 08/15/2025