QUALITY OF PRODUCTS
Our products are produced from the non-woven fabric. This fabric is suitable to EN ISO 13795 standard.This quality provides comfort to both users and patients and easy use for health conditions.These fabrics have the quality of liquid-absorbing and liquid -repellent and on these fabrics we use incision films and medical bands which do not give harm to skin. This quality protects the operation area during the operations and avoid of all kinds of liquid , blood and bacteria penetration. It is our quality princible to use raw material from the suppliers which has CE certificate in the very beginning of the production process. Also for the used raw material, the experiments of CYTOTOXICITY (the experiment of death- toxic on the cell), SENSITIZATION (the experiment of allergic reaction) and IRRITATION (the experiment of allergic reaction on skin) were applied. According to the results of these experiments, it is proved that our raw materials do not cause any reaction to the skin.
Our Surgical Mask production is also conforming with EN ISO 13485: 2016 quality standards, and it is put into use as TYPE II R class after passing the tests specified in EN 14683 standard.
In all processes, the production is analized to control the standards of EN ISO 10993. We prefer to choose the raw material of the suppliers who have CE Certificates and this brings the maximum quality to the product in the first level. Process of production is completed according to the procedures of the system. In our company , we have a cleanroom that compensate the conditions of Class 100.000 We have the capacity of improving our cleanroom accoring to Class 10.000 Our cleanroom’s validation values are constructed according to EN ISO 14644-1 standards.
The packing of our products are made in this cleanroom with the packing machine which its value of packet heat is determined. Medical devices' packing material is suitable for EN ISO 868-7 and it provides all the conditions to make EO gas permeable.
Due to the indicator on the medical device package, we can control the sterilization of the products. After packing the product, labelling is also done in the cleanroom.This labelling is done according to the graphics and symbols of EN ISO 15223-1 standard. Sterilization Process is done according to the conditions that EN 11135-1 standard determines. The sterilization process which is done with ethylene oxide gas, is made according to EN ISO 11135-1 standard. Our company can also make production according to the customers’ requests and needs. The direction signs on the labels and folding method, provides the products to be used as correctly and to be touched at minimum and also isolation from the environment infections for operation area. Ultrasonic sewed gowns protect surgeon and surgery team from the microorganisms grow out from patient infection and also provide confort with floaty texture. When compared with the textile drapes, they minimize the infection risk for patient and comfort and easy use for users. On the other hand if the energy and loss of labour for cleaning of the textile products as to make reusable them are considered, the products which are single use are more economical.
