YY/T 0567.5-2011 Aseptic processing of health care products—Part 5:Sterilization in place

YY/T 0567.3-2011 Aseptic processing of health care products—Part 3:Lyophilization YY/T 0567.4-2011 Aseptic processing of health care products—Part 4:Clean-in-place technologies YY/T 0567.6-2011 Aseptic processing of health care products—Part 6:Isolator systems

ISO 17665-1 GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1:General requirements GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization GB 18281.2-2015 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization GB 18281.3-2015 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes GB 18281.4-2015 Sterilization of health care products—Biological indicators—Part 4:Biological indicators for dry heat sterilization processes GB 18281.5-2015 Sterilization of health care products—Biological indicator—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes GB/T 18281.7-2024 Sterilization of health care products—Biological indicators—Part 7:Guidance for the selection,use and interpretation of results GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements GB 18282.1-2015 Sterilization of health care products—Chemical indicator—Part 1:General requirements GB 18282.3-2009 Sterilization of health care products—Chemical indicators—Part 3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test GB 18282.4-2009 Sterilization of health care products—Chemical indicators—Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration GB 18282.5-2015 Sterilization of health care products—Chemical indicators—Part 5:Class 2 indicators for Bowie and Dick-type air removal tests GB/T 19003-2008 Software engineering—Guidelines for the application of GB/T 19001—2000 to computer software GB/T 19972-2005 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results GB/T 19972-2018 Sterilization of health care products—Biological indicators—Guidance for the selection,use and interpretation of results GB/T 19974-2005 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices YY/T 0567.1-2005 Aseptic processing of health care products—Part 1:General requirements YY/T 0567.1-2013 Aseptic processing of health care products—Part 1:General requirements YY/T 0567.4-2011 Aseptic processing of health care products—Part 4:Clean-in-place technologies GB/T 18281.2-2024 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes GB/T 18281.3-2024 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes GB/T 18281.4-2024 Sterilization of health care products—Biological indicators—Part 4:Biological indicators for dry heat sterilization processes GB/T 18281.5-2024 Sterilization of health care products—Biological indicators—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements GB/T 18281.8-2024 Sterilization of health care products—Biological indicators—Part 8:Method for validation of a reduced incubation time for a biological indicator GB/T 18282.1-2025 Sterilization of health care products—Chemical indicators—Part 1:General requirements GB/T 18282.6-2026 Sterilization of health care products—Chemical indicators—Part 6:Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

ISO 13408-5:2006