YY/T 1658-2019Test method for cyclohexanone released from infusion and transfusion equipments for medical use (English PDF)

Foreword

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

Introduction

At present, most of the domestic disposable infusion and blood transfusion device components use cyclohexanone-based adhesives, and cyclohexanone is used in the formulation. the Lord. Some enterprises directly draw cyclohexanone when they are bonded, and there will be an excess of cyclohexanone in the operation, so that a large number of rings remain in the tube wall and the inner cavity. Hexanone.

The data indicate that cyclohexanone has a central nervous system inhibitory effect and a high concentration of cyclohexanone has an anesthetic effect. Cyclohexanone vapor on mucous membrane It has a strong stimulating effect, and long-term skin contact with cyclohexanone liquid can cause skin irritation and severe conjunctival irritation.

At present, the national standards and industry standards for infusion and blood transfusion devices in China do not specify the limit requirements for cyclohexanone adhesives.

A variety of analytical methods can be used to determine the amount of cyclohexanone dissolved, typical methods include gas chromatography (GC), gas chromatography/mass spectrometry Usage (GC/MS), etc. This standard uses top air phase chromatography as the basic method and gives the test procedure.

Although the type of adhesive used in infusion and blood transfusion apparatus is not limited to cyclohexanone, this standard only gives a method for measuring the amount of cyclohexanone dissolved. another In addition, the clinical application of the device varies greatly. In some cases, the published literature methods include the methods given in this standard.

Not necessarily for all instruments. Therefore, any method that demonstrates reliable analysis can be used. "Reliable analysis" means that the device is specific When the extraction liquid obtained under the leaching medium and the conditions is analyzed for the amount of cyclohexanone eluted, the selected method has sufficient precision, accuracy, and Linearity, sensitivity and selectivity.

1 Scope

This standard specifies the method for determining the amount of cyclohexanone dissolved in infusion and blood transfusion equipment.

This standard applies to infusion and blood transfusion devices using cyclohexanone as a binder.

2 Normative references

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

GB/T 6682 Analytical laboratory water specifications and test methods

3 General

3.1 The room temperature in this standard, if not specified, should be 10 ° C ~ 30 ° C.

3.2 The test water in this standard shall meet the requirements of GB/T 6682.

3.3 Containers used in this standard shall be borosilicate glass containers unless otherwise specified.

3.4 The precision measurement referred to in this standard shall be taken by pipettes that meet the accuracy requirements of the corresponding national standards.

4 Preparation of extract