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Requirements for formulation, validation and routine control of medical device sterilization process

Requirements for formulation, validation and routine control of medical device sterilization process, Total:7 items.

The international standard classification for "Requirements for formulation, validation and routine control of medical device sterilization process" includes: .

The Chinese standard classification for "Requirements for formulation, validation and routine control of medical device sterilization process" includes: .


Japanese Industrial Standards Committee (JISC)

  • JIS T 0806-1:2010 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • JIS T 0806-1:2015 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

RU-GOST R

  • GOST ISO 11137-1-2011 Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices

International Organization for Standardization (ISO)

  • ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Canadian Standards Association (CSA)

  • CSA Z11137-1-07-CAN/CSA-2007 Sterilization of health care products ?Radiation ?Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices First Edition [Superseded: CSA ISO 11137-98-CAN/CSA, CSA ISO 11137-98-CAN/CSA]

German Institute for Standardization

  • DIN EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); English version of DIN EN ISO 17665-1:2006-11

European Committee for Standardization (CEN)

  • EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)