YY/T 0893-2023Gas mixers for medical use - Standalone gas mixers (English PDF)

1 Scope

This document specifies the performance and safety requirements for self-contained gas mixers intended to mix oxygen with another medical gas:

This document does not apply to:

a) Flow meter group with independent control of each gas flow;

b) a separate gas mixer for mixing oxygen and ambient air;

c) an independent gas mixer with more than two different gas inlets;

d) A separate gas mixer connected to the oxygen concentrator:

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references

For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document:

GB/T 3767-2016 Acoustic sound pressure method Determination of sound power level of noise source and sound energy level Approximate free field above the reflecting surface

Process method (ISO 3744:2010, IDT)

GB 9706:1-2020 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:

2012, MOD)

Note: There is no technical difference between the referenced content of GB 9706:1-2020 and the referenced content of IEC 60601-1:2012

GB 9706:255 Medical Electrical Equipment Part 2-55: Particular Requirements for Basic Safety and Essential Performance of Respiratory Gas Monitors (GB 9706:255-2022, ISO 80601-2-55:2018, MOD)

GB 50751 Technical Specifications for Medical Gas Engineering

YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971:2007,

IDT)

YY/T 0799 Medical gas low-pressure hose assembly (YY/T 0799-2010, ISO 5359:2008, MOD)

YY 0801:1 Terminals of medical gas piping system Part 1: Terminals for compressed medical gas and vacuum (YY 0801:1-

2010, ISO 9170-1:2008, MOD)

YY/T 0882 Compatibility of anesthesia and respiratory equipment with oxygen (YY/T 0882-2013, ISO 15001:2003, IDT)

YY 9706:108 Medical Electrical Equipment Part 1-8: General Requirements for Basic Safety and Essential Performance Collateral Standard: General Requirements

Requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems (YY 9706:108-2021, IEC 60601-1-8:

2006/Amd1:2012, MOD)

ISO 7396-1 Medical gas pipeline system Part 1: Medical compressed gas and vacuum pipeline system (Medicalgas pipeline

ISO 10524-1 Pressure regulators for medical gases Part 1: Pressure regulators and pressure regulators with flow meter devices (Pres- flow-meteringdevices)

ISO 11114-3 Gas cylinders - Compatibility of cylinder and valve materials with the gas they contain - Part 3: Non-metallic materials in an oxygen atmosphere […]