Connection Security Tests

Connection Security Tests

Medical devices, especially the connections of medical equipment must be safe, some load and tensile strength should be high, the connections should not be separated in terms of possible fall, insertion or tension, other connection security is in the information technology room can be said as follows, we can perform the connection security of medical devices and medical equipment in our laboratory.

Medical devices are widely used in the field of medicine for the diagnosis and treatment of diseases and disabilities and have many different types and characteristics according to the place and working principles. Especially in parallel with the technological developments experienced in recent years, important developments have been made in medical devices. This is naturally an important factor in improving human health.

In spite of this importance, medical devices also carry serious risks for patients, employees and environmental conditions from time to time. Therefore, it is important to reduce the possible risks of the medical devices and systems used and to take necessary safety measures for human health and the natural environment. The importance of the measures to be taken against the risks of these devices is obvious, since people will be exposed to medical devices in their lives in some way.

The risks posed by medical devices and systems arise to a large extent with connection problems. If there is a connection problem due to the physical structure and the materials needed while working, this may create dangerous situations for human and environmental health. For example, chemicals may be spilled, oxidizing gases may be emitted, radioactive materials may be emitted or toxic gases may be emitted. Such unexpected situations may arise from careless behaviors of employees or they may arise as a result of an accident. In such cases, poisoning and skin burns may occur in patients and workers in the environment, they may be exposed to dangerous radiation or gas accumulation and explosions and fires.

In this respect, the connection security of medical devices and systems used in treatment units such as hospitals and clinics, laboratories, operating theaters, imaging and diagnostic centers, life support units and even ambulances is the most important issue.

The Medical Device Directive No. 1993 / 93 / EEC, published in 42 in European Union countries, divided medical devices into four groups as low-risk, near-risk, mid-risk and high-risk based on the danger situations arising from the design, manufacture and use of medical devices. In our country, the Medical Device Regulation was published by the Ministry of Health in 2011. The main purpose of this regulation is:

  • To determine the basic characteristics of medical devices and equipment
  • When using these devices and equipment, protect them against hazards that could compromise the health and safety of patients, employees, users, and third parties.

The Regulation specifies the principles for the design, classification, production, placing on the market, commissioning and inspection of medical devices and equipment for these purposes. In the annex of the regulation, the criteria that manufacturers should take into account in the design and production of these devices are given (Annex 1).

The connection safety tests of medical devices and systems performed by the competent authorities are based on both these regulations and the standards described by domestic and foreign organizations.

In the meantime, in accordance with the said regulation, medical devices which have been subjected to conformity assessment procedures in accordance with the principles of the regulation and which have CE marking on them have gained the right of free movement. In the conformity assessment process, which is the basis of CE marking studies, it is important that the companies have also performed connection safety tests.

The fact that the manufacturers of medical devices has established and operated the ISO 13485 Medical Devices Quality Management System shows that medical devices and related services are permanently provided in line with customer demands and legal regulations. ISO 13485 certified enterprises are those that manage and manage all kinds of risks, including connection security.

Our company provides connection security test services for enterprises producing and using medical devices in detail with a strong technological infrastructure and staff.