Sterilization of health care products. Moist heat - Guidance on the designation of a medical device to a product family and processing category for steam sterilization

Sterilization of health care products. Moist heat - Guidance on the designation of a medical device to a product family and processing category for steam sterilization

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1   Scope

This part of ISO 17665 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process.

NOTE While this part of ISO 17665 is applicable to health care facilities, it may be used by a manufacturer of a sterile medical device and/or whenever information on reprocessing is required (see ISO 17664).