YY/T 0286.4-2020Special infusion sets - Part 4: Infusion sets for single use with pressure infusion apparatus (English PDF)

Foreword

The "Special infusion sets" standard series is composed of the following parts.

- YY 0286.1 Special infusion sets - Part 1: Infusion sets with precision filters for single use - YY 0286.2 Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1: Fluid lines - YY 0286.3 Special infusion sets - Part 3: Light-resistant infusion sets for single use - YY/T 0286.4 Special infusion sets - Part 4: Infusion sets for single use with pressure infusion apparatus - YY/T 0286.5 Special infusion sets - Part 5: Bottle-type and bag-type infusion sets for single use - YY/T 0286.6 Special infusion sets - Part 6: Infusion sets for single use with graduated flow regulator This Part is Part 4 of YY/T 0286.

This Part was drafted in accordance with the rules given in GB/T 1.1-2009.

This Part replaces YY/T 0286.4-2006. Compared with YY/T 0286.4-2006, the main changes in this Part are as follows.

- CHANGE the nature of the standard, from mandatory to recommended;

- MODIFY the degree of standard adoption, "IDT" (identical adoption) to "MOD" (modified adoption);

- UPDATE the normative references (see Chapter 2; Chapter 2 of the 2006 edition);

- ADD Chapter 3 Terms and definitions (see Chapter 3);

- DELETE the original Chapter 4 Marking (Chapter 4 of the 2006 edition);

- MODIFY the pipeline requirements, which identically adopt the pipeline length requirements of ISO 8536-8 (see 6.11; 6.11 of the 2006 edition);

- MODIFY the storage volume requirements; ADD the Appendix B. Test method for storage volume (see 6.14; 6.14 of the 2006 edition);

- MODIFY the Chapter 10 Requirements for labeling (see Chapter 10; Chapter 10 of the 2006 edition);

- ADD the Chapter 11 Disposal requirements (see Chapter 11);

- DELETE the test method A.4 of the original Appendix A (see A.4 of the 2006 edition);

- MODIFY A.3 Leakage test method (see A.3; A.3 of the 2006 edition).

- UPDATE references.

This Part uses the redrafting method, to modifies and adopts ISO 8536-8:2015 "Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus".

There are technical differences between this Part and ISO 8536-8:2015. Appendix C is added after Appendix A and Appendix B, giving a list of corresponding technical differences and their causes. This Part has also made the following editorial changes.

- ADD the informative Appendix C, giving a list of the corresponding technical differences and their reasons compared with ISO 8536-8:2015.

1 Scope

This Part of the "Specialized infusion sets" series of standards specifies the requirements for sterile supplied disposable infusion sets (hereinafter referred to as "infusion sets"), for infusion equipment which has a pressure of 200 kPa and below.

This Part applies to disposable infusion sets of infusion equipment, which has a pressure of 200 kPa and below.

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.

3 Terms and definitions

The following terms and definitions apply to this document.

The volume of the pipeline under pressure, which is the sum of the filling volume (VF) and the bolus volume (VB).

4 General requirements

The infusion set shall have a protective sheath, to keep the inside of the infusion set sterile before use. The cork piercer or needle of the gas inlet device shall have a protective sheath.

5 Materials

The materials, which are used in manufacturing the infusion set and its components given in Chapter 4, shall meet the requirements of Chapter 6: The materials of the components of the infusion set, that are in contact with the solution, shall also comply with the requirements specified in Chapters 7 and 8.

6 Physical requirements

When testing according to A.3.2 and A.3.4, there shall be no air or water leakage. When testing according to A.3.3, no air shall enter.

The injection piece shall be able to inject into the pipeline. When testing according to A.4, water leakage shall not exceed one drop. The injection piece shall be located at the accessory of male conical joint.

7 Chemical requirements

GB 8368 is applicable.

8 Biological requirements

GB 8368 is applicable.

9 Packaging

GB 8368 is applicable.

10 Labels

Single packaging shall have at least the following information.