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YY 1105-2024: Electirc apparatus for gastric lavage
Status: Valid YY 1105: Evolution and historical versions
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| YY 1105-2024 | English | 279 |
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Electirc apparatus for gastric lavage
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YY 1105-2024
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| YY 1105-2008 | English | 279 |
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Electric apparatus for gastric lavage
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YY 1105-2008
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PDF similar to YY 1105-2024
Standard similar to YY 1105-2024 YY/T 1543 YY/T 0799 YY 0671.1 YY/T 1106 Basic data | Standard ID | YY 1105-2024 (YY1105-2024) | | Description (Translated English) | Electirc apparatus for gastric lavage | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 14,126 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2027-10-15 | | Older Standard (superseded by this standard) | YY 1105-2008 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the safety and performance requirements of electric gastric lavage machines and the corresponding test methods. This standard applies to electric gastric lavage machines used for clinical gastric lavage of adult patients in medical institutions. | YY 1105-2024: Electirc apparatus for gastric lavage---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.01
CCSC46
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 1105-2008
Electric gastric lavage machine
Released on 2024-09-29
2027-10-15 implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Categories 2
4.1 Classification by pressure source (or power source) 2
4.2 Classification by control method 2
5 Cleaning, disinfection and sterilization 2
6 Design 2
6.1 Pipeline 2
6.2 Noise 3
6.3 Sealing 3
6.4 Network power outage 4
6.5 Pressure indicator 4
7 Pressure, flow and liquid volume 4
7.1 Working pressure 4
7.2 Limiting pressure 4
7.3 Traffic 5
7.4 Flushing and aspiration volume 5
7.5 Liquid balance 6
8 Information provided by the manufacturer 6
8.1 Use of symbols 6
8.2 Marking and indication 6
8.3 Attached Documents 6
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, 6.4 and 6.5);
--- 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, 5.4 of the.2008 edition);
--- Changed the requirements and test methods for "working pressure" and "limited pressure" (see 7.1, 7.2, 4.5, 4.7, 5.5, 5.7 of the.2008 edition);
--- Changed the requirements and test methods for "flow" (see 7.3, 4.6 and 5.6 of the.2008 edition);
--- Changed the requirements and test methods for "flushing and liquid absorption" (see 7.4, 4.8.2 and 5.8.2 of the.2008 edition);
--- Changed the requirements for “information provided by the manufacturer” (see Chapter 8, 4.2 and Chapter 7 of the.2008 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed and coordinated by the State Food and Drug Administration.
The previous versions of this document and the documents it replaces are as follows.
---First published in 1987 as ZBC46003-1987;
---First revised in.1999 as YY 91105-1999;
---Revised for the second time in.2008 to YY 1105-2008;
---This is the third revision.
Electric gastric lavage machine
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.
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