Biomedical Engineering Reference
In-Depth Information
plastics, of which Class VI requires the most stringent testing of all
the six classes. These tests measure and determine the biological
response of animals to the plastic by either direct or indirect contact,
or by injection of the specific extracts prepared from the material
under test. The tests are described as
a. Systemic toxicity test
to determine the irritant effect of toxic
leachables present in extracts of test materials
b. Intracutaneous test to assess the localized reaction of tissue to
leachable substances
c. Implantation test to evaluate the reaction of living tissue to the
plastic
The extracts for the test are prepared at one of three standard tem-
peratures/times: 50°C (122°F) for 72 h, 70°C (158°F) for 24 h, 121°C
(250°F) for 1 h.
26. Typical testing data for disposable bioreactors (as supplied by GE
Healthcare) would include
• Testing is performed on irradiated film (50 kGy):
• USP XXII plastic class VI and ISO 10993:
• ISO 10993-4 Hemolysis study in vivo extraction method
• ISO 10993-5 Cytotoxicity study using ISO elution method
• ISO 10993-6 Muscle implantation study in rabbit
• ISO 10993-10 Acute intracutaneous reactivity study in rabbit
• ISO 10993-11 Acute systemic toxicity in mouse
Appendix I: Use of International Standard
ISO-10993 “Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing”
Background
The biological evaluation of medical devices is performed to determine the
potential toxicity resulting from contact of the component materials of the
device with the body. The device materials should not either directly or
through the release of their material constituents: (i) produce adverse local
or systemic effects; (ii) be carcinogenic; or (iii) produce adverse reproduc-
tive and developmental effects. Therefore, the evaluation of any new device
intended for human use requires data from systematic testing to ensure that
the benefits provided by the final product will exceed any potential risks
