YY/T 0286.6-2020Special infusion sets - Part 6: Infusion sets for single use with graduated flow regulator (English PDF)

Foreword

YY/T 0286 "Special infusion set" includes the following parts.

---Part 1: Disposable microporous filter infusion set;

---Part 2: Gravity infusion of disposable burette infusion set;

---Part 3: Disposable light-proof infusion set;

---Part 4: Infusion sets for disposable pressure infusion equipment;

---Part 5: Disposable bottle type and bag type infusion set;

---Part 6: One-time use scale flow regulating infusion set. This part is part 6 of YY/T 0286.

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

This part replaces YY 0286.6-2009 "Special infusion set Part 6: One-time use flow setting fine-tuning infusion set", and Compared with YY 0286.6-2009, the main technical changes except for editorial changes are as follows.

---Added terms and definitions (see Chapter 3);

---Added the schematic diagram of the scale flow regulator (see Figure 2);

---Reliability requirements are modified (see 6.2.1);

---Modified the performance requirements for infusion flow rate (see 6.3);

---Modified the performance requirements of the stop clamp or switch (see 6.4);

---Added the leakage test of the infusion set (see 6.5);

---Modified the single package mark (see 9.2);

---Modified the flow control characteristic test method (see Appendix A);

---Added the leakage test method of the infusion set (see Appendix B);

---Added references.

This part uses the redrafting method to refer to ISO 8536-13:2016 ``Liquid contact single-use scaled flow regulators''.

The degree of consistency with ISO 8536-13:2016 "Liquid contact single-use scaled flow regulator" is not equivalent.

Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.

Introduction

With the continuous development of infusion technology and the increasing clinical requirements, some infusions that can be adapted to special clinical requirements have been produced.

Device. Since the development of products is endless, it is impossible to expect all infusion sets with special requirements to be included in a standard of. Therefore, each part of "Special Infusion Sets" only regulates these special infusion sets for a certain clinical special requirement. Some dedicated input The infusion set may also belong to a variety of special infusion sets, and at the same time implement the applicable part of the "special infusion set".

In some special applications, it is required to control the infusion flow rate stably. The scale flow regulating infusion set is to meet this Specially designed for the requirements of clinical applications. Compared with ordinary flow regulators, the scale flow regulator of this infusion set has the advantage of being able to Keep the flow stable and realize the flow setting according to the scale. Appendix D in GB 8368 is applicable to this part.

1 Scope

This part of YY/T 0286 specifies the single-use infusion set used for gravity infusion and can achieve scale flow adjustment (hereinafter abbreviated Called the infusion set) to ensure compatibility with other intravenous infusion devices.

This section applies to single-use infusion sets that mark the scale numbers on the scale flow adjustment device and are used for gravity infusion.

This section does not apply to infusion sets that are not marked with scale numbers on the scale flow adjustment device.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.

GB 8368 single-use infusion set gravity infusion type (GB 8368-2018, ISO 8536-4:2010/AMD1.2013, MOD)

3 Terms and definitions

The following terms and definitions apply to this document.

4 General requirements

4.1 The infusion set and scale flow regulator are shown in Figure 1 and Figure 2.

Note: Figure 1 shows an air intake infusion set, it can also be a non air intake infusion set, see GB 8368. Figure 1 and Figure 2 are not unique, as long as the same effect can be achieved As a result, other configurations can also be used.

4.2 The infusion set should have a protective cover to keep the inner cavity of the infusion set sterile before use. The cork piercer or needle of the air intake device should have a protective cover.

5 Materials

The materials for manufacturing the infusion set and its components given in Chapter 4 should meet the requirements of Chapter 6: The components of the infusion set in contact with the liquid The materials should also meet the requirements specified in Chapter 7 and Chapter 8.

6 Physical requirements

7 Chemical requirements

GB 8368 applies.

8 Biological requirements

GB 8368 applies.

9 Signs

10 Packaging

GB 8368 applies.

11 Disposal

Information on the safe and environmentally sound disposal of single-use infusion sets should be provided in the accompanying documents, such as "must be used in accordance with the established "No biohazard disposal procedures for the disposal of blood-contaminated products" or equivalent text.

Appendix A (Normative appendix) Flow control characteristic test method

Appendix B (Normative appendix) Infusion set leak test

B.1 Before the start of the test, adjust the state of the infusion set at the test temperature. B.2 Follow the instructions provided by the manufacturer.

B.3 Set the scale flow regulator to the "on" position and connect one end of the infusion set to a compressed air source. Close the other end of the infusion set, Immerse in (40±1)°C water, apply pressure 50kPa higher than atmospheric pressure to the inside of the infusion set for 15s, and check whether the infusion set is free No leakage, and repeat the test on the scale with the maximum scale value of 25%, 50% and 75% of the scale flow regulator closest to the number marked.

B.4 Set the scale flow regulator to the "off" position, connect one end of the infusion set to the compressed air source and open the other end. Dip the infusion set Into the water at (40±1)°C, apply a pressure of 50kPa higher than the atmospheric pressure to the inside of the infusion set for 15s. Check the open end of the infusion set Are there any leaks. Finally, close the open end of the pipeline, keep the test sample at a pressure of 50kPa higher than the atmospheric pressure for 15s, and check Check the scale flow regulator for any air leakage.

B.5 Set the scale flow regulator to the "on" position, and fill the infusion set with debubbled distilled water; one end of the infusion set is sealed, and the other end is connected Connect to the vacuum device, apply a pressure of -20kPa to the inside at (40±1)°C for 15s to check whether air enters the infusion set. On the scale The flow regulator is set in the "off" position, and the maximum scale values of 25%, 50% and 75% are closest to the scale marked with numbers and repeat the test. references