YY 0585.1-2019Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1: Fluid lines (English PDF)

Foreword

YY 0585 "Fluid lines for use with pressure infusion equipment and accessories for single use" includes the following parts.

--- Part 1: Fluid lines;

--- Part 2: Accessories;

--- Part 3: Filters;

--- Part 4: Check valves. This part is Part 1 of YY 0585.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This part replaces YY 0585.1-2005 "Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1: Fluid lines". Compared with YY 0585.1-2005, the main technical changes except editorial changes are as follows.

--- The "Normative references" is updated;

--- The original Chapter 3 "Marking" is deleted, and Chapter 3 "Terms and definitions" is added;

--- The requirements of 5.5 are modified;

--- The requirements of 5.8 are modified, and the test method for storage volume in

--- Appendix C (Normative) is added.

--- The requirements of 5.9 and the test method of A.5 are modified;

--- The requirements of labels in Chapter 9 are modified;

--- The requirements for disposal in Chapter 10 are added;

--- The test method in A.4 is modified;

--- The original test method in A.5 is deleted;

--- The "References" is updated.

This part is modified in relation to ISO 8536-9:2015 "Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment".

There are technical differences between this part and ISO 8536-9:2015. The clauses involved in these differences have been marked by a vertical single line (|) in the margin beside them. A list of the corresponding technical differences and their reasons is given in Appendix D. The following editorial change is made in this part.

--- Appendix D (informative) is added after Appendix A, Appendix B, and Appendix C, which gives a list of the corresponding technical differences compared with ISO 8536-9:2015 and their reasons. […]

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

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