scope:

The focus of this document is to provide guidance for health care manufacturers in the selection and qualification of polymeric materials, ceramics, and metals in health care products that are sterilized by the following modalities:

• radiation (gamma, electron beam, or x-ray),

• ethylene oxide (EO),

• moist heat (steam),

• dry heat,

• hydrogen peroxide, and

NOTE-All references to hydrogen peroxide sterilization in this TIR refer to sterilization in the gas phase. Hydrogen peroxide is also used for liquid chemical sterilization, but that application is outside the scope of this TIR.

• ozone.

Guidance in this TIR relates to

• material selection-choosing sterilization-compatible materials (see clause 3 and Annexes A-F);

• material processing-optimizing the functional performance of materials selected, to avoid processing errors that can contribute to negative effects from sterilization (see clause 4);

• material testing-challenging critical aspects of the product for functionality and safety after sterilization and aging (see clause 5); and

• accelerated aging-applying programs that ensure correlation with real-time aging while reducing the cost and amount of time required for material qualifications (see clause 6).

NOTE-Information in this TIR is not intended to provide a rationale for the use of materials without proper qualification of the materials. The information is general in nature and is intended only as a guide to successfully initiating material qualification programs.