Leakage is an action that should not be in particular in medical and medical devices, the leakage may manifest in a nature that leads to chemical intoxications that will produce many microbial releases. Some leaks may also prevent the right treatment, so the leaks can have fatal effects for the patient or the creature during the treatment process. We perform leakage tests of medical devices in our laboratory.
We do leak tests on some industrial products.
A safe product means products that do not pose a risk to consumers under normal use or whose risk is within acceptable limits. This definition also applies to medical devices. In the relevant legal regulations and domestic and foreign standards, medical devices are basically considered as three classes:
- General medical devices
- Active medical devices that can be implanted
- In vitro medical diagnostic equipment
Market surveillance and inspection activities are carried out for these devices in order to:
- Determining whether the product is manufactured in accordance with the relevant legal regulations
- To check whether it is safe for human health
- Ensuring that unsafe products are made secure
- Apply a sanction if necessary
Medical devices are defined in the relevant legal regulations as follows: medical devices are devices which, when used by humans, do not provide their primary function with pharmacological (drugs), immunological (immune system) or metabolic (chemical reactions in the body) effects, but which can be supported by these effects when performing its function.
In general, medical devices are used to diagnose and diagnose a disease, to prevent, monitor, treat or alleviate its effects. It is also used to diagnose, treat or mitigate the effects of injury and injury.
The responsibility of medical device manufacturers is to provide reliable products to the market at all times.
In general, some mechanical hazards encountered in all devices may be of a magnitude that threatens human health in medical devices. These hazards may vary depending on the structure of the medical device, the materials used and the auxiliary equipment used. Nevertheless, the main hazards encountered are: compression, impact, winding, scissors, falling, spraying and swelling. A leak can also be added to these hazards.
It is primarily the responsibility of the manufacturer to prevent the effects of these mechanical hazards on human health. Medical devices must be sufficiently stable under the intended operating conditions. It must be pressure-resistant in the prescribed operating environment and this durability shall continue throughout the life of the device, subject to the maintenance conditions specified by the manufacturer.
Medical gases and gasses belonging to devices are the most frequently encountered situation in hospitals and clinics. Such gases may present hazards as a result of accidents or misuse during use. In this case, gases leaking into the environment can cause high-pressure explosion, fire, poisoning or suffocation if inhaled, and burning as a result of contact with skin or eyes.
Leakage in medical devices involves different hazards depending on the chemical properties of the leaking gas. Therefore, the properties of medical gases should be well known and necessary precautions should be taken accordingly.
Persons working in the presence of medical gases must know and apply the properties, hazards, first aid and protection rules and briefly all safety rules related to the gases described by the manufacturer.
In the event of a leakage, medical gases are generally caustic, which pose a health risk to patients and employees. These gases are used in treatment units such as hospitals and clinics, laboratories, operating theaters, imaging and diagnostic centers, life support units and even ambulances, sometimes for treatment purposes and sometimes during the operation of some devices. For example, patients may be provided with oxygen, nitrogenprotoxide and medical compressed dry air. The medical gases used in the devices are ethylene oxide, pure acetylene gas, liquid nitrogen, gas nitrogen, helium, carbon dioxide and argon. These gases, which may leak from medical devices, may create health risks.
Our company provides leakage testing services for enterprises producing medical devices in detail with a strong technological infrastructure and staff.