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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

Similar standards

Editions of YY 1105

EditionTitleRevisionStatus
YY 1105-2024Electric apparatus for gastric lavagecurrent editionCurrent
YY 1105-2008Electric apparatus for gastric lavageprevious editionIn 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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