YY 0679-2008 Sterilizers for medical purposes-Low temperature steam and formaldhyde sterilizers

YY/T 0679-2016 Low temperature steam and formaldehyde sterilizers for medical purposes

ISO 11138-5 IEC 61010-2-042 EN 867-5 EN 60584-2:1993 EN 60751:1995 医疗器械说明书、标签和包装标识管理规定　国家食品药品监督管理局 消毒产品标签说明书管理规范　中华人民共和国卫生部 GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 18268-2000 Electrical equipment for measurement, control and laboratory use—EMC requirements GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.21-2010 Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 21:Particular requirements—Test configurations,operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications GB/T 18268.22-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 22:Particular requirements—Test configurations,operational conditions and performance criteria for portable test,measuring and monitoring equipment used in low-voltage distribution systems GB/T 18268.23-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 23:Particular requirements—Test configurations,operational conditions and performance criteria for transducers with integrated or remote signal conditioning GB/T 18268.24-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 24:Particular requirements—Test configurations,operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9 GB/T 18268.25-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 25:Particular requirements—Test configurations,operational conditions and performance criteria for field devices with interfaces according to IEC 61784-1,CP 3/2 GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment GB/T 18268.31-2022 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 31:Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety)—General industrial applications GB/T 18268.32-2022 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 32:Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety)—Industrial applications with specified electromagnetic environment 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/T 19633-2005 Packaging for terminally sterilized medical devices GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.22-2025 Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 22:Particular requirements—Test configurations, operational conditions and performance criteria for portable testing, measuring and monitoring equipment used in low-voltage distribution systems GB/T 18268.21-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 21:Particular requirements—Test configurations,operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications GB/T 191-2025 Graphical symbols marking for handling and storage of packages

EN 14180:2003