EN ISO 11135-1:2007 – Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

4.4 Measurement, analysis and improvement — Control of nonconforming product Procedures for control of product designated as nonconforming and for correction, corrective action and preventive action shall be specified. These procedures shall comply with the applicable clauses of ISO 13485.
5 Sterilizing agent characterization
5.1 Sterilizing agent The composition, storage conditions and shelf life for the sterilizing agent shall be specified. NOTE With respect to this part of ISO 11135, the sterilizing agent is ethylene oxide or a mixture of ethylene oxide and a diluent.
5.2 Microbicidal effectiveness Microbicidal effectiveness data shall be developed if it is proposed to use the ethylene oxide outside of the range of compositions that are widely recognized or if a novel diluent is to be used.
NOTE The inactivation of microorganisms by ethylene oxide has been comprehensively documented in the literature.
This literature provides a knowledge of the manner in which the process variables affect microbial inactivation. Reference to these general studies on microbial inactivation is not required by this part of ISO 11135.
5.3 Material effects The effects of ethylene oxide on a wide variety of materials used to manufacture medical devices have been comprehensively documented and such documentation is of value to those designing and developing medical devices that are to be sterilized by ethylene oxide.
This part of ISO 11135 does not require the performance of specific studies on material effects, but does require performance of studies of the effects of ethylene oxide on product (see Clause 7). The materials and outcomes of all tests shall be recorded, together with the criteria against which the properties of materials were assessed.
5.4 Environmental considerations
5.4.1 The potential effect on the environment of the operation of the sterilization process shall be assessed and measures to protect the environment shall be identified. This assessment, including potential impact and measures for control, shall be documented.
5.4.2 Users of ethylene oxide shall comply with applicable local, national and international requirements regarding the emission and disposal of ethylene oxide and its diluents.
6 Process and equipment characterization
6.1 Process characterization
6.1.1 The range of process variables and the equipment necessary to deliver the sterilization process safely and reproducibly shall be defined and documented.
6.1.2 Process characterization shall include:
a) preconditioning (if used);
b) the sterilization cycle;
c) aeration (if used).
6.1.3 The characterization of the sterilization cycle shall include:
a) air removal;
b) conditioning (if used);
c) ethylene oxide injection;
d) maintenance of specified conditions for the exposure time;
e) ethylene oxide removal;
f) flushing (if used);
g) air/inert gas admission.
EN ISO 11135-1:2007 – Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices