YY/T 1574-2017 Tissue engineering medical device products—Standard guide for immobilization or encapsulation in alginate gels

GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials 中华人民共和国药典(2015年版) GB 16352-1996 Standards for γ-rays radiation sterilization of disposable medical appliances GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices 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 YY/T 0606.8-2008 Tissue engineered medical products—Part 8:Alginate 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