Material selection
The selection of materials is directly related to the sterilization method selected for the built-in medical device.
Common sterilization methods include:
EO (ethylene oxide) sterilization: applicable materials APET HIPS PP PETG, etc;
Irradiation sterilization (? Or e-beam): suitable for PETG (high dose);
In addition, in addition to the sterilization method, it also has a certain relationship with the material and risk assessment of the customer's built-in products. At present, the common material in the medical device industry is PETG, which is widely used in the three categories of medical devices and export products; APET will occupy a certain share in Class II medical devices; The first type of anesthesia bags mainly use HIPS materials.
PETG
Parameters of some materials
PETG parameters
|
Sterilization method：Eto（2）& Gamma （50KGY） |
Reference sample | Gamma | ETO | |
| density | D792 | 1.33 | 1.33 | 1.33 |
| Thermal deformation temperature at 1.82MPA（℃） | D648 | 62 | 61 | 58 |
| Thermal deformation temperature at 0.46MPA（℃） | D648 | 67 | 62 | 58 |
| MPA | D790 | 2163 | 2102 | 2147 |
| MPA | D790 | 73 | 73 | 80 |
| Notch impact strength (J/M, 23 ℃ complete fracture) | D790256 | 71 | 65 | 65 |
| 43 days Color L | CIE1976 | 92.8 | 92.6 | 92.9 |
| A | CIE1976 | -0.5 | -0.7 | -0.5 |
| B | CIE1976 | 1.7 | 3.4 | 1.6 |
| Haze | Haze | 3 | 2.7 | 2.9 |
| Parallel transmittance（%） | D1003 | 79 | 79 | 80 |
| Complete light transmittance（%） | D1003 | 84 | 83 | 84 |
APET
| Sterilization method：Eto（2）& Gamma （50KGY） | Reference sample | Gamma | ETO | |
| density | D792 | 1.28 | 1.28 | 1.28 |
| Thermal deformation temperature at 1.82MPA（℃） | D648 | 63 | 58 | 55 |
| Thermal deformation temperature at 0.46MPA（℃） | D648 | 67 | 58 | 55 |
| MPA | D790 | 2033 | 2004 | 2088 |
| MPA | D790 | 69 | 69 | 75 |
| Notch impact strength (J/M, 23 ℃ complete fracture) | D790256 | 104 | 100 | 96 |
| 43 days Color L | CIE1976 | 95 | 95.1 | 95 |
| A | CIE1976 | -0.6 | -0.7 | -0.5 |
| B | CIE1976 | 1.4 | 1.9 | 1.3 |
| Haze | D1003 | 0.2 | 0.2 | 0.9 |
| Parallel transmittance（%） | D1003 | 87 | 88 | 87 |
| Complete light transmittance（%） | D1003 | 90 | 90 | 90 |
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