In years past, the Association for the Advancement of Medical Instrumentation (AAMI) standards have been on their toes to ensure that companies involved in the manufacture of medical devices, equipment and even personal protective equipment (PPE) work according to the regulatory standards of quality.
This, you can tell is a good way to curb the activities of unscrupulous manufacturers of half-baked medical devices and equipment in the industry.
With the activities of such unscrupulous manufacturers through the manufacturer of sub-standard equipment, it is very glaring the lives and safety of health workers and other people in health facilities will be highly endangered through exposure to infections.
More so, with the current rise in the spread of the most dreaded COVID-19 pandemic, it therefore becomes very important that health service providers and workers are protected from this deadly disease while trying to save the lives of others.
With all these facts and factors put into consideration, it therefore becomes mandatory for medical equipment such as isolation gowns from various manufacturers to be subjected to different level of test by the AAMI.
These test are usually unique to the type of isolation gown under test, as well as the level of protection in which such gowns and other PPE will provide to the person wearing the gown.
And for us here, in Wellmien Imp. & Exp. Trading Co., Ltd., we recently subjected our low level risk isolation gowns for level 2 test by the AAMI
With our isolation, which has been manufactured to provide barrier to the penetration of liquid materials either through soaking, fluid exposure or even through splatter, the level 2 AAMI test seems to be the most perfect test to certify. that our products meets the global regulatory standards for medical-devices.
In order to certify the conformity of our isolation gowns, two test are usually carried out to ascertain the level of protection of the gown. These test include;
a. Water impacting the surface of the gown material
b. Pressurizing the material
Test Standards
Also, as a way of ensuring that there is no bias in the test when carried out on any product, the medical-devices are usually tested against a well-laid out stand procedure for each level of protection.
So, for our low risk isolation gown, which were tested by the AAMI, the two test standards in which they were subjected to include;
1.Water Resistance-Impact Penetration Test AATCC42-2017;
2.Water Resistance-Hydrostatic Pressure Test AATCC127-2018;
Test Requirement
During the testing of our low risk isolation gown through level 2 test, some test requirements that are usually needed for the test include the following;
1.All critical zone A and B - Impact Penetration Test AATCC42≤1.0g;
2.All critical zone - Hydrostatic Pressure Test AATCC127≥20cm H2O
Applicability of our low risk isolation gowns
Our high-quality and high-durable low risk isolation gowns which were put through the level 2 AAMI test are specially manufactured for use in the following areas of application;
1. Blood draw from a vein
2. Suturing
3. Intensive care unit as well as the
4. Pathology lab
Contact us for high-quality Isolation gowns
At Wellmien Imp. & Exp. Trading Co., Ltd., we are known for the manufacture of the best and high-quality isolation gowns and other medical protective gears.
Kindly click here to contact us for any of our high-end medical products at an affordable price.
