YY 1105-2024Electric apparatus for gastric lavage (English PDF)
电动洗胃机
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
September 29, 2024
Implementation date
October 15, 2027
Scope
YY 1105-2024 is the English-translated version of 电动洗胃机.
YY 1105-2024 is the Chinese standard "Electric apparatus for gastric lavage". Its scope clause reads: This document specifies the safety and performance requirements for electric gastric lavage machines and describes the corresponding test methods.
This document applies to electric gastric lavage machines used for clinical gastric lavage of adult patients in medical institutions. Its clauses include terms and definitions.
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Document preview — YY 1105-2024
National Standard of the People's Republic of China
- ICS
- 11.040.01
- Classification
- C46
- Replacing
- YY 1105-2008
Issued by: National Medical Products Administration
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Categories
- 4.1 Classification by pressure source (or power source)
- 4.2 Classification by control method
- 5 Cleaning, disinfection and sterilization
- 6 Design
- 6.1 Pipeline
- 6.2 Noise
- 6.3 Sealing
- 6.4 Network power outage
- 6.5 Pressure indicator
- 7 Pressure, flow and liquid volume
- 7.1 Working pressure
- 7.2 Limiting pressure
- 7.3 Traffic
- 7.4 Flushing and aspiration volume
- 7.5 Liquid balance
- 8 Information provided by the manufacturer
- 8.1 Use of symbols
- 8.2 Marking and indication
- 8.3 Attached Documents
1 Scope
This document specifies the safety and performance requirements for electric gastric lavage machines and describes the corresponding test methods.
This document applies to electric gastric lavage machines used for clinical gastric lavage of adult patients in medical institutions.
2 Normative references
The contents of the following documents constitute the 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/T 3767-2016 Acoustics - Determination of sound power level and sound energy level of noise source by sound pressure method - Approximate free field above reflecting surface
Cheng Fa
GB/T 3785.1 Electroacoustic sound level meter Part 1.Specification
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance
GB/T 16273.1 Graphical symbols for equipment Part 1.General symbols
YY/T 0466.1 Symbols for medical devices used to provide information for manufacturers Part 1.General requirements
3 Terms and definitions
The terms and definitions defined in GB 9706.1 and the following apply to this document.
3.1 Infusion volume
The amount of fluid sucked out by the electric gastric lavage machine after completing a flushing process.
Note. Sometimes also called gastric fluid intake.
3.2 Working pressure
The maximum pressure in the gastric lavage circuit of the electric gastric lavage machine under normal use.
3.3 Air pump type
A method of using an air pump as a power source to complete the process of entering and exiting the stomach.
Note. The structure of the air pump is not limited, including piston pump, plunger pump, vane pump, diaphragm pump, peristaltic pump, etc.
3.4 Manual-control type
The gastric lavage process is completed by manual control.
3.5 Water pump type
A method of using a water pump as a power source to complete the process of entering and exiting the stomach.
Note. The structural form of the water pump is not limited, including piston pump, plunger pump, vane pump, diaphragm pump, peristaltic pump, etc.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 10 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 3767-2016Acoustics -- Determination of sound power levels and sound energy levels of noise sources using sound pressure -- Engineering methods for an essentially free field over a reflecting plane
- GB/T 3785.1Electroacoustics - Sound level meters - Part 1: Specifications
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 16273.1Graphical symbols for use on equipment -- Part 1: Common symbols
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Editions of YY 1105
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 1105-2024 | Electric apparatus for gastric lavage | current edition | Current |
| YY 1105-2008 | Electric apparatus for gastric lavage | previous edition | In force until 2027-10-15 |
This page sells the current edition, YY 1105-2024. 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 1105-2024
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