YY 0585.1-2005Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1: Fluid lines (English PDF)

1 Scope

This part of YY 0585 specifies the physical, chemical, and biological requirements for single-use sterile fluid lines for pressure infusion equipment.

This part applies to single-use sterile fluid lines for pressure infusion equipment with a maximum pressure of 200 kPa, including.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document;

for the undated documents, only the latest version (including all the amendments) is applicable to this standard.

GB/T 1962.21) Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2.Lock fittings (GB/T 1962.2-2001, ISO 594-

2.1998, IDT)

3 Terms and definitions

The following terms and definitions apply to this document.

The increased volume of the tube when it is pressurized (VS) in comparison to the non- pressurized tube volume (VF).

4 Materials

The materials from which the fluid lines are manufactured shall meet the requirements specified in Chapter 5, Chapter 6, and Chapter 7.

5 Physical requirements

The fluid lines shall be manufactured with minimal particulate contamination. Fluid pathway surfaces shall be smooth and clean. When the test is carried out according to

A.2, the pollution index shall not be exceeded.

6 Chemical requirements

GB 8368 is applicable, and the test method is shown in Appendix B.

7 Biological requirements

GB 8368 is applicable.

8 Packaging

GB 8368 is applicable.

9 Labelling

A single package shall be labeled with at least the following information.

The shelf or multi-unit package shall be labeled with at least the following information.

10 Disposal

Information on the safety and environmentally biosafety disposal of single-use infusion sets shall be given in accompanying documents.

Example. “Be sure to dispose of blood-contaminated products in a manner consistent with established biosafety disposal procedures”, or other equivalent text.

Appendix A (Normative)

Physical test

Fill the fluid line with distilled water, and check visually whether the interface between water and air is visible.

Appendix B (Normative)

Chemical test

Take 450 cm of tubing and all other components (like adapters) that have a total surface area of 100 cm2.Disassemble the components that are in contact with the liquid medicine in the sterilized and ready-to-use fluid line, and arrange them according to the same material.

Appendix C (Normative)

Storage volume

This appendix describes the different measurable tube volumes and the test methods for measuring each volume through clear definitions.

Appendix D (Informative)

Technical differences between this part and ISO 8536-9.2015 and their reasons

YY 0585.4-2024 | YY 0585.2-2019 | YY 0585.3-2018 | YY/T 0573.3-2025 | […]