YY/T 1610-2025 Anaesthetic and respiratory equipment—Passive humidifiers

YY/T 1610-2018 Anaesthetic and respiratory equipment—Oxygen humidifiers for medical use

GB/T 3767-2016 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Engineering methods for an essentially free field over a reflecting plane GB/T 3785.1-2023 Electroacoustics—Sound level meters—Part 1:Specifications GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.212-2020 Medical electrical equipment—Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process 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 GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes GB/T 42062-2022 Medical devices—Application of risk management to medical devices GB/T 44059.1-2024 Medical gas pipeline systems—Part 1:Pipeline systems for compressed medical gases and vacuum YY/T 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0753.2-2009 Breathing system filters for anaesthetic and respiratory use—Part 2:Non-filtration aspects YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer YY/T 0916.1-2021 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements YY/T 1040.1-2015 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets YY/T 1474-2016 Medical devices—Application of usability engineering to medical devices YY/T 1778.1-2021 Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 1:Evaluation and testing within a risk management process YY 9706.111-2021 Medical electrical equipment—Part 1-11:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment YY 9706.274-2022 Medical electrical equipment—Part 2-74:Particular requirements for basic safety and essential performance of respiratory humidifying equipment EN 13544-2:2002 ISO 80369(所有部分)

ISO 20789:2018