CAN CSA Z17665-1-09 Sterilization of Health Care Products - Moist Heat - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

This Standard replaces CAN/CSA-ISO 11134-98, requirements for sterilization, validation and routine control of healthcare products, industrial moist heat sterilization ISO 11134.

This section of CAN CSA 17665 specifies requirements for the development, validation, and routine control of a moist heat sterilization process for medical devices.

Moist heat sterilization processes covered in this section of CAN CSA 17665 include, but are not limited to:

• Saturated steam ventilation systems;
• Saturated steam active air evacuation systems;
• air vapor mixtures;
• water spray;
• Immersion in water.

This part of CAN CSA 17665 does not apply to sterilization processes that rely on a combination of moist heat with other biocidal agents (eg formaldehyde) as the sterilizing agent.

This standard does not detail a specific requirement to designate a medical device as "sterile". It does not specify a quality management system for the control of all stages of the production of medical devices.

Having a complete quality management system during manufacture is not a requirement of this part of 17665, but elements of the quality management system that are the minimum necessary to control the sterilization process are normatively referred to in the text where appropriate.

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