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ISO 11135 - Sterilization of Health Care Products Package

ISO 11135-1 and ISO/TS 11135-2 - HISTORICAL PACKAGE

ISO 11135 - Sterilization of Health Care Products Package specifies the requirements for the development, validation and routine control of ethylene oxide sterilization process for medical devices and other healthcare products. ISO 11135 - Sterilization of Health Care Products Package includes ISO 11135-1:2007, ISO/TS 11135-2:2008 and ISO/TS 11135-2/Cor1:2009.

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International Organization for Standardization [ISO]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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