Objective To develop a gas chromatography-mass spectrometric(GC-MS) method for the determination and evaluation of ethylene chlorohydrin (ECH)  residue in PTA balloon dilatation catheter. Methods The ECH residue were extracted in acetone by ultrasonic bathing. Chromatographic column: ZB-624, inlet temperature 180℃, split ratio 1:1, high purity He as carrier gas, column flow rate 1.5mL/min. Temperature programmed condition: 50℃ (1min), 5℃/min to 100℃; Mass spectrometric conditions were as follow: ion source temperature 230℃，the interface temperature between GC and MS was 250℃, electrical energy 70 eV. Qualitative analysis was carried out by retention time and mass spectrometric scan , m/z between 35～500, and quantified by select ion monitoring method (SIM), m/z=43. The ECH was determined by external standard method under the SIM mode by GC-MS. Results The number of theoretical plates were more than 56753. A good linearity was obtained at the concentrations of 1.44~22.96 μg/mL with a correlation of 0.999 and the average recovery was 99.1% (n=5, RSD<5%). The minimum limit of ECH was 0.41μg/mL. No ECH was found in the sample. Conclusions The method of GC-MS is sensitive, rapid and accurate for determination of ECH residue in PTA balloon dilatation catheter products. It can be used for quality control of PTA balloon dilatation catheter and for peers reference.