PASS ISO 10993-5
Tecoflex
EG-80A EG-85A EG93A EG-100A EG-60D EG-65D EG-72D
.
Tecothane
TT-1074A TT-1085A TT-1095A TT-1055D TT-1065D TT-1069D TT-1072D TT-1075D-M
.
Carbothane
PC-3575A PC-3585A PC-3895A PC-3555D PC-3572D
.
Tecoplast
TP-470-000
...............................................................
Biocompathbility and biostabilaty test results
|
|
Tecoflex
EG-80A
|
Tecoflex
EG-60D
|
Tecothane
TT-1085A
|
Carbothane
PC-3585A
|
|
Hom olysis
ISO 10993-4
|
PASS
|
PASS
|
PASS
|
PASS
|
|
Systemic Injection
ISO 10993-11
|
PASS
|
PASS
|
PASS
|
PASS
|
|
Intracutaneous Test
ISO 10993-10
|
PASS
|
PASS
|
PASS
|
PASS
|
|
Implantation-2 week
ISO 10993-6
|
PASS
|
PASS
|
PASS
|
PASS
|
|
Pyrogen
ISO 10993-11
|
PASS
|
PASS
|
PASS
|
PASS
|
|
In Vitro Hemocompatibility
ISO 10993-4
|
PASS
|
PASS
|
PASS
|
PASS
|
|
Physiochemical
USP 24
|
PASS
|
PASS
|
PASS
|
PASS
|
EN ISO 10993 Biological evaluation of medical devices:
EN ISO 10993-1:
Evaluation and testing
EN ISO 10993-2:
Animal welfare requirements
EN ISO 10993-3:
Tests for genotoxicity, carcinogenicity and reproductive toxicity
EN ISO 10993-4:
Selection of tests for interactions with blood
EN ISO 10993-5:
Tests for in vitro cytotoxicity
EN ISO 10993-6:
Tests for local effects after implantation
EN ISO 10993-7:1996
Ethylene oxide sterilization residuals
EN ISO 10993-8:2001
Part 8: Selection and qualification of reference materials for biological tests
EN ISO 10993-9:1999
Framework for identification and quantification of potential degradation products
EN ISO 10993-10:
Tests for irritation and delayed-type hypersensitivity
EN ISO 10993-11:
Tests for systemic toxicity
EN ISO 10993-12:2004
Sample preparation and reference materials
EN ISO 10993-13:1999
Identification and quantification of degradation products from polymeric medical devices
EN ISO 10993-14:2001
Part 14: Identification and quantification of degradation products from ceramics
EN ISO 10993-15:2001
Identification and quantification of degradation products from metals and alloys
EN ISO 10993-16:1997
Toxicokinetic study design for degradation products and leachables
EN ISO 10993-17:2002
Establishment of allowable limits for leachable substances
EN ISO 10993-18:
Chemical characterization of materials
EN ISO 10993-20:
Part 20: Principles and methods for immunotoxicology testing of medical devices
**All type grades conform to the requirements of. USP(U.S. Pharmacopoeia ) Class
VI and ISO 10993 tests
**Small ex-stock sell in USA...
