YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

ISO 15198 ISO 18113-1 ISO 18113-4 ISO 18113-5 IEC 60068-2-64:1993 IEC 61010-2-101:2002 EN 13532:2002 EN 13612 EN 13640 WHO技术报告丛书(No.889 1999)　附录3　用于控制口服抗凝药治疗的凝血活酶和血浆的指导术语和定义 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 17626.2-1998 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test GB/T 17626.2-2006 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test GB/T 17626.2-2018 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test GB/T 17626.3-1998 Electromagnetic compatibility—Testing and measurement techniques-Radiated, radio-frequency, electromagnetic field immunity test GB/T 17626.3-2006 Electromagnetic compatibility—Testing and measurement techniques—Radiated, radio-frequency, electromagnetic field immunity test GB/T 17626.3-2016 Electromagnetic compatibility—Testing and measurement techniques—Radiated,radio-frequency,electromagnetic field immunity test GB/T 17626.3-2023 Electromagnetic compatibility—Testing and measurement techniques—Part 3:Radiated,radio-frequency,electromagnetic field immunity test 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/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis 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 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples

ISO 17593:2007