Iso 11737 2-2009- Sterilization Of Medical Devices ....pdf Better -

Consider a manufacturer of single-use laparoscopic instruments sterilized with ethylene oxide (EO). During (per ISO 11135), they must:

It is important to distinguish Part 2 from its sibling document, Part 1 (ISO 11737-1). While Part 1 deals with the enumeration of microbial populations (bioburden) on products prior to sterilization,

This standard provides the methodology for: