Medical device residual ethylene oxide detector

Medical device residual ethylene oxide detector——Applicable for the detection of residual ethylene oxide in all disposable medical supplies disinfected and sterilized with ethylene oxide sterilization devices.

[Scope of Product Use]

Applicable for the detection of residual ethylene oxide in all disposable medical supplies disinfected and sterilized with ethylene oxide sterilization devices.

Some products are listed as follows:

Disposable sterile syringes, disposable blood products, disposable plasma separation cups, disposable leukocyte filters

Disposable plasma bag, disposable blood collection device, disposable sterile catheter, disposable blood container

Disposable protective mask, disposable protective suit, soft tissue expander, medical surgical mask

Medical degreased cotton implantable drug delivery device, medical infusion set, medical blood transfusion set

Execution standard for residual detection of ethylene oxide

GB/T 14233.1-2008 Methods for inspection of medical infusion, transfusion, and injection equipment - Part 1: Chemical analysis methods

GB/T 16886.7-2001 Biological Evaluation of Medical Devices Part 7: Residual Ethylene Oxide Sterilization

Detection of residual ethylene oxide by gas chromatography

1. Experimental equipment: gas chromatograph——Medical device residual ethylene oxide detector

2. Testing principle: At a certain temperature, extract the ethylene oxide (EO) contained in the sample with an extractant water, and determine the content of EO using headspace gas chromatography.

3. Standard storage solution preparation method (weighing method):

Take an externally dried 50ml volumetric flask, add about 30ml of water, add a stopper, weigh to the nearest 0.1mg. Inject about 0.6ml of ethylene oxide into the flask without a stopper, gently shake well, cover the flask with a stopper, weigh, and the difference between the two weighings is the weight of ethylene oxide contained in the solution. Add water to the mark and dilute the solution to 1 × 10-2g/L as the standard stock solution.

4. Testing method:

4.1 Take an appropriate amount of ethylene oxide standard solution and prepare six concentration standard solutions. Take 10ml each and prepare six concentration standard samples.

When the standard sample reaches gas-liquid equilibrium, different concentrations of liquid correspond to different concentrations of gas. Take the equilibrium gas, inject it into the sampler, and record the peak height (or area) of ethylene oxide.

4.3 Based on the peak height (or area) corresponding to different concentrations of standard solutions, plot the peak height (or area) - concentration of 1.5 and calculate the residual amount of ethylene oxide according to the formula.