DD CEN ISO/TS 11135-2:2008

Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1 | Status: Superseded, Withdrawn

1 Scope This Technical Specification provides guidance for the requirements in ISO 11135‑1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135‑1:2007 apply also to this Technical Specification. For ease of reference, the clause numbering in this Technical Specification corresponds to that in ISO 11135‑1:2007. Further guidance for the requirements given in ISO 11135‑1 is also included in Annex C of ISO 11135‑1:2007 and should be used in conjunction with this Technical Specification. This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135‑1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.