YY 0585.2-2019Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2: Accessories (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 2 of YY 0585.

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

This part replaces YY 0585.2-2005. Compared with YY 0585.2-2005, appendix D is added after appendix A, appendix B, and appendix C, and the main technical changes except editorial changes are as follows.

--- The degree of standard adoption is changed from "IDT" (identical) to "MOD" (modified);

--- Chapter 3 "Marking" is deleted;

--- The requirements for Unit with Injection Site in 4.8 are modified;

--- The requirements for Unit with Check Valve in 4.9 are modified, and A.8 is deleted;

--- Chapter 6 "Biological requirements" is modified to "GB 8368 is applicable" for ease of implementation;

--- The requirements for labelling in Chapter 8 are amended, and the requirement that the symbol 2725 of ISO 7000 can be used to indicate the presence of a substance of concern is added;

--- Chapter 9 "Disposal" is added;

--- The leakage test method in A.4 is modified, among which the negative pressure test is deleted;

--- The leakage test for adapters with female and/or male conical fittings in A.5 is deleted.

This part is modified in relation to ISO 8536-10:2015 "Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment".

There are technical differences between this part and ISO 8536-10:2015.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, which gives a list of the corresponding technical differences compared with ISO 8536-10:2015 and their reasons.

1 Scope

This part of YY 0585 specifies the physical, chemical, and biological requirements for accessories used with pressure infusion equipment.

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 Materials

The materials from which accessories are manufactured shall meet the requirements specified in Chapter 4, Chapter 5, and Chapter 6.

4 Physical requirements

The accessories shall be impermeable to air, microorganisms and fluid. No matter where the plug is located, it shall be sealed. When the test is carried out according to A.4, there shall be no air or water leakage.

5 Chemical requirements

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

6 Biological requirements

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

7 Packaging

GB 8368 is applicable.

8 Labelling

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

9 Disposal

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

Appendix A (Normative) Physical test

Fill the accessory to be tested with distilled water according to the usual operation method, and visually check whether there are air bubbles in the fluid pathway of the transparent components.

Appendix B (Normative) Chemical test

Take components with a total area of 100 cm².Disassemble the components that are in contact with the fluid line in the sterilized and ready-to-use accessory, and arrange them according to the same material.

Appendix C (Normative) Biological test

GB 8368 is applicable.

Appendix D (Informative)

Technical differences between this part and ISO 8536-10:2015 and their reasons