How the safety of compression knitwear materials is checked

The safety of medical compression knitwear materials is assessed taking into account the composition of the product, the nature and duration of its contact with the skin. The verification includes analysis of documentation and studies according to a program developed for the specific product. Confirmed safety of materials does not replace individual selection: the purpose, compression class, duration, and wearing regimen depend on the clinical situation and are determined by the attending physician.

Why not only the fabric composition is checked

Compression stockings, socks, and tights come into direct contact with the skin. Therefore, when assessing safety, not only the main fibers but also other components are important: dyes, finishing substances, and fixing elements.

In Russian practice, information about the composition and quality of materials is considered together with the technical and operational documentation for the medical product. Toxicological studies include document analysis, sample identification, and their verification according to an approved program. VNIIMT of Roszdravnadzor.

What does GOST R 58236-2020 establish

GOST R 58236-2020 "Medical elastic compression products. General technical requirements. Test methods" applies, among other things, to medical compression hosiery products. It establishes requirements and methods for verifying characteristics that determine the product's performance: sizes, stretchability, strength, changes after washing, compression class, and pressure distribution. GOST R 58236-2020. For medical compression knitwear, this is crucial: the material must not only withstand use but also provide the specified compression characteristics. At the same time, testing according to GOST R 58236-2020 and the assessment of biological safety address different tasks. GOST R 58236-2020 is dedicated to the technical characteristics of compression products.

What properties of materials are assessed

Chemical characteristics

Specialists study what substances are included in the composition of materials and can be released from them under certain conditions. For specific studies, extracts are used - liquids into which the substances released by the sample transition. The results are considered in light of the properties of the detected components, their quantity, and the expected contact with the body. The detection of a substance does not itself indicate an unacceptable risk.

Biological action

When assessing the contact of a medical product with the skin, the potential damaging effect on cells, the ability to cause irritation, and allergic sensitivity are considered.

Assessment direction

What is studied

Cytotoxicity

Possible damaging effect of the material or its extract on cells in a laboratory system

Irritant action

Potential for local irritant reaction

Sensitizing action

Ability to cause the formation of allergic sensitivity

These are the directions for assessing biological action. The necessity for specific tests is determined within the framework of a justified program, taking into account the available data. GOST ISO 10993-1-2021.

Why the safety of materials does not replace proper selection

The tolerance of compression knitwear depends not only on the composition. On the website «Actual Phlebology», when discussing the use of compression in elderly patients, the condition of the skin, individual selection of size and model is emphasized. An unsuitable product can be accompanied by discomfort, and sensitive skin requires special attention from the physician.   This means that the assessment of materials and the assessment of tolerance by a specific patient complement each other. One symptom alone cannot determine whether discomfort is related to the material, fit, or skin condition.

The company «Ekoten» is one of the largest Russian manufacturers of medical compression knitwear. The Luomma Idealista line includes compression stockings, socks, tights, sleeves, and gloves. The range includes models for wide thighs, allowing for anatomical features during selection.

How materials and the medical purpose of the product are related

Medical compression knitwear is used to address specific clinical tasks. Russian clinical guidelines "Varicose veins of the lower extremities" consider compression treatment as part of the care for patients with venous diseases. Its use may be associated with a reduction in venous symptoms and swelling, as well as accompanying certain interventions. The specific task and compression parameters are determined by the physician. Clinical guidelines.

Therefore, when evaluating products, it is necessary to consider several components: medical status, safety of materials, confirmed compression characteristics, and the possibility of correct selection.

What documents are important for the medical organization and supplier

When working with compression knitwear, documents help verify whether the supplied products meet the declared characteristics.

Document or information

What they allow to verify

Registration certificate and registry entry

Medical status of the product, manufacturer, and compliance of the supplied version with the registered one

Instructions for use

Purpose, contraindications, limitations, rules for use and care

Materials for assessing biological safety

What samples and indicators were studied, to which products the results apply

Technical testing protocols

What methods were used to verify the declared characteristics, including compression

Labeling and size chart

Article, compression class, size, length, and features of execution

Registration information can be compared with the official registry of Roszdravnadzor. Documents regarding the Russian origin of the products and materials assessing their biological safety have different purposes. Inclusion in the Register of Russian industrial products does not replace registration documents and research results for the medical product.

The company «Ekoten» has been producing medical compression knitwear for over 17 years. All products have undergone clinical trials and have Registration Certificates, are included in the Register of Russian industrial products, and are marked with the "Made in Russia" certificate. Medical compression knitwear is produced in accordance with the requirements of GOST R 58236-2020 and GOST ISO 13485:2017. Any decisions regarding the appointment of compression products are made exclusively by the attending physician. This material is for informational purposes only. Follow our group on VKontakte.