GB 11246-1989
Abolished
YY/T 1804-2021
Active
Industry standards-Medicine
YY/T 1804-2021 Anaesthetic and respiratory equipment—Spirometers intended for the measurement of time forced expired volumes in humans
YY/T 1804-2021 Anaesthetic and respiratory equipment—Spirometers intended for the measurement of time forced expired volumes in humans
Basic Information
Standard Code:
YY/T 1804-2021
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:
2021-09-06
Implement Date:
2023-05-01
Pages:
28 pages
Scope
This standard specifies the requirements for spirometers used to evaluate the lung function of people weighing more than 10 kg.
This standard applies to all spirometers used to measure forced expiratory volume, regardless of the measurement method used. Spirometers can be part of an integrated lung function device or a standalone device.
This standard does not apply to devices intended for continuous monitoring of patients.
Development Information
Referenced Standards
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
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
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 26782:2009
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