publisherAmanda
time2023/03/31
Biocompatibility test basis for spunlace non-woven fabric (mask fabric)
The overall safety target of Proyons spunlace non-woven fabrics,
facial mask fabrics and other products is based on the test of DIN EN ISO10993
series standards (mandatory requirements for medical devices), which can
evaluate non-woven fabrics (including spunlace, spunbond and other
non-manufactured fabric product categories) ) compatibility with the skin,
mucous membranes and immune system.
(1) Cytotoxicity test according to DINEN ISO10993-5 to exclude
cell damage effects;
(2) According to DINEN ISO10993-5 and combined with the
literature published by wiegand, C. et al. in 2017 ("Biocompatibility test
optimization scheme for compression stockings and similar products in close
contact with skin in vitro", Textile Journal, volume 109 , No. 7,
891-902), cytotoxicity test on materials containing elastic fibers;
(3) According to DIN EN ISO 10993-10, use recognized screening
tests and animal substitution tests for sensitization tests to assess the
potential sensitization risks of the inspected products;
(4) Chicken Embryo Chorioallantoic Membrane Test (HET-CAM)
according to Method Abstract No. 96 of the Database of Alternative Methods for
Animal Testing (DB-ALM) is a recognized alternative method for rabbit eye
animal testing that meets the requirements of DINEN ISO10993-10, To exclude
chemical stimuli;
(5) Hazardous substances are tested according to OEKO-TEXR
STANDARD 100.
According to the certification requirements of different
customers, Proyons will implement comprehensive certification including
biocompatibility testing for products. For more details, please contact us!
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