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 is the mandatory standard for the electric gastric lavage machine, the pump used in emergency departments to wash the stomach after poisoning or overdose. It specifies the safety and performance requirements for electric gastric lavage machines and the corresponding test methods. The device alternately instils and withdraws fluid through a tube in a patient who is often unconscious, so the pressures it can generate in both directions, the volume control and the behaviour of the system when the tube blocks are safety characteristics rather than performance niceties. The YY prefix without /T makes compliance compulsory in China, and the 2024 edition takes effect on 15 October 2027. For a manufacturer or an importer of gastric lavage equipment, this is the governing standard.
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
- 1 Scope1
- 2 Normative references1
- 3 Terms and Definitions1
- 4 Categories2
- 4.1 Classification by pressure source (or power source)2
- 4.2 Classification by control method2
- 5 Cleaning, disinfection and sterilization2
- 6 Design2
- 6.1 Pipeline2
- 6.2 Noise3
- 6.3 Sealing3
- 6.4 Network power outage4
- 6.5 Pressure indicator4
- 7 Pressure, flow and liquid volume4
- 7.1 Working pressure4
- 7.2 Limiting pressure4
- 7.3 Traffic5
- 7.4 Flushing and aspiration volume5
- 7.5 Liquid balance6
- 8 Information provided by the manufacturer6
- 8.1 Use of symbols6
- 8.2 Marking and indication6
- 8.3 Attached Documents6
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part
1.Structure and drafting rules for standardization documents" Drafting. This document replaces YY 1105-2008 "Electric Gastric Lavage Machine". Compared with YY 1105-2008, except for structural adjustments and editorial changes, In addition, the main technical changes are as follows:
--- Changed the "Normative References" (see Chapter 2, Chapter 2 of the.2008 edition);
--- Added terms and definitions (see Chapter 3);
--- Deleted the non-technical contents of "Instrument Working Conditions" and "Test Rules" (see
4.1 and Chapter 6 of the.2008 edition);
--- Deleted some requirements and methods (see 4.3, 4.11, 4.12, 4.13, 5.3, 5.11, 5.12,
5.13 of the.2008 edition);
--- Changed the requirements and test methods for "Cleaning, disinfection and sterilization" (see Chapter 5, 4.10.3,
5.10.3 of the.2008 edition);
--- Added the requirements and test methods for "inner diameter", "network power interruption" and "pressure indicator" of external pipes (see 6.1.1,
--- Changed the requirements and test methods for pipeline "anti-flattening" and "pressure resistance" (see 6.1.2,
4.10.2 of the.2008 edition, 5.10.2);
--- Changed the test method for "noise" (see 6.2,
1 Scope
YY 1105 is the mandatory standard for the electric gastric lavage machine, the pump used in emergency departments to wash the stomach after poisoning or overdose. It specifies the safety and performance requirements for electric gastric lavage machines and the corresponding test methods. The device alternately instils and withdraws fluid through a tube in a patient who is often unconscious, so the pressures it can generate in both directions, the volume control and the behaviour of the system when the tube blocks are safety characteristics rather than performance niceties. The YY prefix without /T makes compliance compulsory in China, and the 2024 edition takes effect on 15 October 2027. For a manufacturer or an importer of gastric lavage equipment, this is the governing standard.
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
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 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
GB/T 3767-2016 · GB/T 3785.1 · GB/T 16273.1
Similar standards
YY/T 1543|YY/T 0799|YY 0671.1|YY/T 1106
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
YY/T 0466.1-2023 — Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
YY 0017-2026 — Implants for osteosynthesis - Metallic bone plates
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