scope:

This document provides guidance for health care product manufacturers in the selection and qualification of polymeric materials, ceramics, and metals for use in health care products sterilized by the following methods:

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

• Ethylene oxide (EO)

• Moist heat (steam)

• Dry heat

• Hydrogen peroxide

• Nitrogen dioxide

• Vaporized peracetic acid

• Liquid peracetic acid

• Hydrogen peroxide-ozone

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.)

Guidance in this TIR relates to the following:

a) Material selection: Choosing sterilization-compatible materials (see Section 3 and Annexes A-I)

b) Material processing: Optimizing the functional performance of materials selected to avoid processing errors that can contribute to negative effects from sterilization (see Section 4)

c) Material testing: Challenging critical aspects of the product for functionality and safety after sterilization and aging (see Section 5)

d) Accelerated aging: Applying programs that ensure correlation with real-time aging while reducing the cost and time required for material qualifications (see Section 6)

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