Publications

According to EN ISO 14683 and EN ISO 10993

Abich can test masks for biomedical use, according to EN ISO 14683 and EN ISO 10993, using the following assays:

– Determination of bacterial filtration efficiency (BFE)
– Resistance to breathing (Delta P)
– Bioburden (microbiological cleaniness of the mask)
– Biocompatibility (cytotoxicity, skin irritation and sensitization or bibliographic evaluation).

Method for Evaluation of Preinjection Skin Preparations

Regulatory reference:	According to ASTM ASTM E1173 – 15.
Claim:	Effectiveness of alcohol swabs
Application field:	Finished products.
Description of the test:	The test method is designed to measure the reduction of the microflora of the skin for Preinjection Skin Preparations. This test method is conducted on human subjects selected randomly from a group of subjects who, after refraining voluntarily from using topical and oral antimicrobials for at least two weeks (14 days), exhibit acceptably high normal flora counts on the skin sites to be used in testing.

Assessment of Antimicrobial Activity Using a Time-Kill Procedure

Regulatory reference:	According to ASTM E2315 – 16.
Claim:	Kills 99.99% of germs
Application field:	Finished products.
Description of the test:	Antimicrobial activity of specific materials is measured with this technique by measuring the changes in a population of aerobic microorganisms within a specified sampling time. This test can be used in particular for the hand sanitizers with the claim “kills 99.99% of germs”.

Regulatory reference:	According to OECD 456.
Claim:	No endocrin disruption
Application field:	Raw ingredients and finished products.
Description of the test:	The purpose of the test is identifying substances that interfere with 17-ß estradiol and testosterone production.

Regulatory reference:	ISO 24444:2019.
Claim:	Salt water resistant
Application field:	Finished sunscreen products.
Description of the test:	Test performed on 10 volunteers, by comparison of pre-wash and post-wash SPF. The treatment includes two washes, one in salt water, performed by irroration with 1M NaCl solution by a pressureless drop shower, and one in fresh water. If the reduction of protection is greater than than 50% the product isn’t considered to be “Salt Water Resistant”.

Regulatory reference:	ISO 24444:2019.
Claim:	Sand resistant
Application field:	Finished products.
Description of the test:	In vivo test on 10 subjects. Comparison between SPF of sun product and the reduction on protection cause of double sand static contact of 20 minutes in this sequence: contact, techanical cleaning, contact and final mechanical cleaning before the exposure to the solar multiport simulator. If the reduction of protection is mayor than 50% the product isn’t “sand resistant”.

Regulatory reference:	Proprietary method.
Claim:	Anti-aging and Reduces signs of aging
Application field:	Raw materials and finished products.
Description of the test:	In vitro evaluation of the synthesis of hyaluronic acid up to 48h following exposure to the sample, in several concentrations, on skin and dermal papillae fibroblasts.

Regulatory reference:	Proprietary method
Claim:	Antioxidant and Anti-pollution
Application field:	Raw materials and finished products.
Description of the test:	In vitro test for the evaluation of the protective effect against air pollution. The purpose of this test is to evaluate the efficacy of the sample in reducing ROS release in response to a mix of heavy metals and atmospheric dust particulate in a skin-derived cell model.

Regulatory reference:	FDA “guidelines for effectiveness testing of antiperspirant drug products”, CFR 21 protocol
Claim:	Anti-perspirant activity
Application field:	Active ingredients, mixtures or finished products.
Description of the test:	The test is carried out on 30 volunteers. Pre-treatment cycle of 17 days, treatment cycle with the anti-perspiration product for 4 days, exposure in acclimatized room for the times and in the conditions laid down according to the FDA normative at T 24 hours subsequently to the interruption of the anti-perspiration treatment. Gravimetrical reading with analytical balance at T 24 hours of the treated side against the high non-treated armpit. Report in English with Wilkoxon method statistical analysis.

Regulatory reference:	OECD n° 492
Claim:
Application field:	Chemicals and mixtures.
Description of the test:	Identification of chemicals and mixtures which do not require classification as (severe) eye irritants by the evaluation of their cytotoxic effect against an in vitro reconstituted corneal epithelium model. NOTE: If irritating, requires further testing to determine the degree of irritative action.