ISO 20857:2010

Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

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Referenced standards

IEC 61010-1:2010IEC 61010-2-040:2005ISO 10012:2003ISO 10993-1:2009ISO 11138-1:2006ISO 11138-4:2006ISO 11140-1:2005ISO 11607-1:2006ISO 11607-2:2006ISO 11737-1:2006ISO 11737-2:2009ISO 13485:2003
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ISO 20857:2010

Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.

Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

Edition2010
Published Date2010
Published ByInternational Standardization Organisation
Page Count58