YY/T 1438-2026 Pending Industry standards-Medicine

YY/T 1438-2026 Anaesthetic and respiratory equipment—Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

YY/T 1438-2026 Anaesthetic and respiratory equipment—Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

Publish Date: 2026-03-09 Implement Date: 2027-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 1438-2026

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Surgical room equipment

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2026-03-09

Implement Date: 2027-03-01

Pages: 28 pages

Scope

This document specifies the requirements for peak expiratory flow meters (PEFM) intended for evaluating the lung function of autonomous breathers.
This document applies to all medical devices used to measure the peak expiratory flow of autonomous breathers, whether they are part of a comprehensive lung function medical device or a standalone medical device.

Development Information

Word Count: 38 Thousand words Pages: 28 pages

Replace the following standards

YY/T 1438-2016 Anaesthetic and respiratory equipment—Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

Referenced Standards

GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance 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 YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements

Adopt standards

ISO 23747:2015

Related Standards

GB 11246-1989 Abolished

GB 11246-1989 Specifications for continuous flow inhalational anaesthetic machines for use with humans

Publish Date: 1989-03-31

YY 0339-2002 Replaced

YY 0339-2002 Suction catheter for use in the respiratory tract

Publish Date: 2002-09-24

YY/T 0337.1-2002 Active

YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors

Publish Date: 2002-09-24

YY/T 0337.2-2002 Active

YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube

Publish Date: 2002-09-24

YY/T 0338.1-2002 Replaced

YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults

Publish Date: 2002-09-24

YY/T 0338.2-2002 Replaced

YY/T 0338.2-2002 Tracheostomy tubes—Part 2:Paediatric tracheostomy tubes

Publish Date: 2002-09-24