Legislation/Applicable standard

ReferenceTitle
LVS EN ISO 11137-1:2006Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
LVS EN ISO 11137-2:2007Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
LVS EN ISO 11137-2:2007 /AC:2009Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006/Cor 1:2009)
LVS EN ISO 11138-2:2009Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
LVS EN ISO 11138-3:2009Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
LVS EN ISO 11140-1:2009Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
LVS EN ISO 11140-3:2009Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
LVS EN ISO 11197:2009Medical supply units (ISO 11197:2004)
LVS EN ISO 11607-1:2009Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
LVS EN ISO 11607-2:2006Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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