YY/T 1768.1-2021 Needle-based injection systems for medical use—Requirements and test methods—Part 1:Needle-based injection systems

YY/T 1768.2-2021 Needle-based injection systems for medical use—Requirements and test methods—Part 2:Needles

GB/T 2423.4-2008 Environmental testing for electric and electronic products—Part 2:Test method—Test Db:Damp heat,cyclic(12 h+12 h cycle) GB/T 2423.10-2019 Environmental testing—Part 2:Tests methods—Test Fc:Vibration(sinusoidal) GB/T 3359-2009 Statistical interpretation of data—Determination of statistical tolerance intervals YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0664-2008 Medical device software—Software life cycle processes YY/T 1474-2016 Medical devices—Application of usability engineering to medical devices YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests ISO 11608-3 ISO 11608-4 ISO 11608-5 GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 18779.1-2002 Geometrical Product Specifications (GPS)—Inspection by measurement of workpieces and measuring equipment—Part 1:Decision rules for proving conformance or non-conformance with specifications GB/T 18779.1-2022 Geometrical product specifications (GPS)—Inspection by measurement of workpieces and measuring equipment—Part 1:Decision rules for verifying conformity or nonconformity with specifications GB/T 27418-2017 Guide to the evaluation and expression of uncertainty in measurement YY/T 1768.2-2021 Needle-based injection systems for medical use—Requirements and test methods—Part 2:Needles

ISO 11608-1:2014