YY/T 1438-2016 Anaesthetic and respiratory equipment.Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (English Version)
This standard specifies the requirements for peak expiratory flow meters (PEFMs) intended for use in the evaluation of lung function in spontaneously breathing persons. This standard applies to all devices used to measure peak expiratory flow in spontaneously breathing persons, whether part of a comprehensive pulmonary function device or a separate device.
YY/T 1438-2016 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 19974 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*， 2018-05-14 Update
YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
YY/T 1438-2016 history
2016YY/T 1438-2016 Anaesthetic and respiratory equipment.Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans