YY/T 0109-2024Medical ultrasonic nebulizer (English PDF)
医用超声雾化器
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 29, 2024
Implementation date
October 15, 2025
Scope
YY/T 0109-2024 is the English-translated version of 医用超声雾化器.
YY/T 0109-2024 is the Chinese standard "Medical ultrasonic nebulizer". Its scope clause reads: This document specifies the requirements for medical ultrasonic nebulizers (hereinafter referred to as "nebulizers") and describes the corresponding test methods.
This document applies to medical ultrasonic nebulizers that use ultrasound to atomize liquid drugs. Its clauses include terms and definitions.
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Document preview — YY/T 0109-2024
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C41
- Replacing
- YY/T 0109-2013
Issued by: National Medical Products Administration
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 3.2 Nebulization quantity
- 3.3 Nebulization rate
1 Scope
This document specifies the requirements for medical ultrasonic nebulizers (hereinafter referred to as "nebulizers") and describes the corresponding test methods.
This document applies to medical ultrasonic nebulizers that use ultrasound to atomize liquid drugs.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
YY/T 1420 Environmental requirements and test methods for medical ultrasonic equipment
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility
Requirements and tests
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
The electrical frequency that excites the ultrasonic oscillation of the nebulizer.
Note. The unit of ultrasonic oscillation frequency is megahertz (MHz).
3.2 Nebulization quantity
For a given filling volume, the total volume or total mass of liquid that the nebulizer can atomize.
Note. The unit of total atomization volume is milliliters (mL) or grams (g).
3.3 Nebulization rate
The volume or mass of liquid atomized by the atomizer per unit time.
Note. The unit of atomization rate is milliliters per minute (mL/min) or grams per minute (g/min).
3.4
When the particles are sorted by size, the volume of particles larger than it and smaller than it each accounts for 50% of the total volume of the particles.
Particle size.
Note. The unit of volume median particle size is micrometer (µm).
3.5
When the particles are sorted by aerodynamic size, the mass of particles larger and smaller than it each accounts for a portion of the total mass of the particles.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- YY/T 1420Environmental requirement and test methods for medical ultrasonic equipment
- YY 9706.102Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Editions of YY/T 0109
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0109-2024 | Medical ultrasonic nebulizer | current edition | Current |
| YY/T 0109-2013 | Medical ultrasonic nebulizer | previous edition | In force until 2025-10-15 |
This page sells the current edition, YY/T 0109-2024. Earlier editions are listed for reference only.
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
GB 9706.12-1997 — Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
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YY/T 0109-2024
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