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YY/T 1856-2023: General requirements for the safety of blood/intravenous fluid/irrigation fluid warmers
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| YY/T 1856-2023 | English | 329 |
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General requirements for the safety of blood/intravenous fluid/irrigation fluid warmers
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YY/T 1856-2023
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Basic data | Standard ID | YY/T 1856-2023 (YY/T1856-2023) | | Description (Translated English) | General requirements for the safety of blood/intravenous fluid/irrigation fluid warmers | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 17,110 | | Date of Issue | 2023-03-14 | | Date of Implementation | 2025-05-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the general requirements for the safety of fluid warmers for blood, intravenous medicine, and lavage fluid. This document applies to warmers for blood, IV fluids, and irrigation fluids. This document does not apply to: non-pipe fluid warmers, such as warming cabinets, fresh frozen plasma/fresh red blood cell thawing devices, electric cooker heaters; extracorporeal/cardiac bypass warming circulation systems; heaters integrated into dialysis devices thermostat. | YY/T 1856-2023: General requirements for the safety of blood/intravenous fluid/irrigation fluid warmers
---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.
ICS11:040:20
CCSC31
Pharmaceutical Industry Standard of the People's Republic of China
Warmers for blood, venous medicine, and lavage fluid
General Safety Requirements
fluid warmers
Released on 2023-03-14
2025-05-01 Implementation
Released by the State Drug Administration
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:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed by the State Drug Administration:
This document is under the jurisdiction of the National Standardization Technical Committee of Medical Infusion Sets (SAC/TC106):
This document was drafted by: Shandong Institute of Medical Devices and Drug Packaging Inspection, Beijing Jingjing Medical Equipment Co:, Ltd:, Baxter Medical
Supplies Trading (Shanghai) Co:, Ltd:, Smith Medical Devices (Beijing) Co:, Ltd:
The main drafters of this document: Yu Xiaohui, Zhao Zenglin, Zhang Ke, Liu Guichi, Zhu Qingliang, Liu Yinghui, Mou Pengtao, Liu Jun, Li Yan:
Introduction
Due to the frequent use of warmers for blood, IV fluids, and irrigation fluids on patients in the operating room, intensive care unit, and other settings, there is a need for
Special attention is given to fluid warmers:
The purpose of this document is to establish safety requirements for fluid warmers that minimize the risk to patients and operators, and to specify that compliance has been
Confirmed test:
K (Kelvin) is a recognized unit symbol for absolute temperature and temperature difference, but since all measurements are made with the Celsius scale
equipment, so ℃ is used throughout this document:
The "*" marked in front of the item number in this document indicates that there is further explanation of the item in Appendix A:
Warmers for blood, venous medicine, and lavage fluid
General Safety Requirements
1 Scope
This document specifies the general safety requirements for fluid warmers (collectively referred to as fluid warmers) (see 3:2) for blood, intravenous drug solutions, and lavage fluids:
This document applies to warmers for blood, IV fluids, and irrigation fluids:
This document does not apply to:
--- Fluid warmers for non-pipelines, such as warming cabinets, fresh frozen plasma/fresh red blood cell thawing devices, electric cooker heaters;
---Extracorporeal/cardiac bypass warming circulatory system;
---Warmer integrated into the dialysis unit:
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document:
GB/T 1002 Types, basic parameters and dimensions of single-phase plugs and sockets for household and similar purposes
GB 9706:1-2020 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
GB/T 17465 (all parts) Household and similar appliance couplers
3 Terms and Definitions
The following terms and definitions defined in GB 9706:1-2020 apply to this document:
3:1
Fluid path fluidpath
A channel intended to infuse or lavage a patient from its source (such as a blood bag, infusion bag, or irrigation fluid bag) to the patient:
NOTE: The fluid pathway is an applied part:
3:2
fluid warmer fluidwarmer
fluid expected to flow in a line (through a closed path) from a source (such as a blood bag, infusion bag, or irrigation fluid bag) to the patient
Heated equipment: include:
--- warmer for blood in the pipeline;
---Warmer for in-line intravenous infusion;
--- A warmer for the lavage fluid in the pipeline:
*3:3
set temperature setpointtemperature
The temperature set by the operator on the fluid warmer at the desired temperature of blood, IV solution, or irrigation fluid:
3:4
Temperature from the fluid warmer sensor and displayed by the fluid warmer:
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