GB 11246-1989
Abolished
YY/T 1438-2016
Active
Industry standards-Medicine
YY/T 1438-2016 Anaesthetic and respiratory equipment—Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
YY/T 1438-2016 Anaesthetic and respiratory equipment—Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
Basic Information
Standard Code:
YY/T 1438-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Surgical room equipment
ICS Name:
Anesthesia, respiration, and resuscitation equipment
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
25 pages
Scope
This standard specifies the requirements for peak expiratory flow meters (PEFMs), which are intended for evaluating the lung function of spontaneously breathing individuals.
This standard applies to all devices used to measure the peak expiratory flow of spontaneously breathing individuals, whether they are part of a comprehensive lung function device or a standalone device.
Development Information
Referenced Standards
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
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
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 19974-2005 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 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
Adopt standards
ISO 23747:2007
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