Test
Services
Sterilization
Gamma
Radiation - ISO 11137, EN 560, AAMI,
TIR 27:2001
Is the most rapid sterilization method and has
well established processes for sterilizing polymer-based
medical devices. High-energy radiation produces
ionization and excitation in polymer molecules.
It can discolor plastics and modify their structure.
Gamma radiation has greater penetration than E-beam.
For smaller batches E-beam may be more economical,
gamma radiation leaves no residuals. Gamma radiation
is used in many single-use medical supplies.
E-beam
- ISO 11137, EN 560, AAMI, TIR 27:2001
About 70% of products are compatible with electron-beam
(E-beam) sterilization. E-beam sterilization can
be harmful to products containing batteries or
electronic components. Electron beams aren't as
certain to reach every crack and crevice in a
device. Therefore sterilizers put dosimeters in
hard-to-reach areas to determine if the products
have received a sufficient dose. Devices can also
be rotated for a second dose to ensure the beam
reaches all sides. E-beam is great for consumables
and high-value devices such as cardiothoracic
devices.
Ethylene
Oxide (EtO) - ANSI, AAMI, ISO 11135,
EN550
Gas Sterilization is popular for devices made
from metals and some plastics. It is limited to
the thickness of the device. Vacuums are sometimes
used to ensure penetration within the device.
Temperature and relative humidity are constantly
monitored and recorded. It can sterilize plastics
with physical properties that may degrade with
irradiation. It will not degrade packaging materials.
|
