YY/T 1856-2023General requirements for the safety of blood, intravenous fluid and irrigation fluid warmers (English PDF)

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: