Übersetzung für "Single use device" in Deutsch

This medicine is a clear, colourless solution, provided in a single-use nasal spray device.

The hand-held device 100 is a single-use device, a so-called disposable.

Therefore the valve device 40 can also be referred to as a single use valve device.

Each of the above-described injection devices may be designed as a single-use device, either fully or in part.

As the materials for the single-use dispensing device, all feasible plastic materials can be utilized.

In addition to public health considerations, the reprocessing of single use medical device may raise ethical and liability concerns.

In this way, a particularly economic single-use dispensing device can be manufactured to which the sealing seams of the invention can easily be applied.

The nasal spray device is a single-use device that delivers a total of 28 mg of esketamine, in two sprays (one spray per nostril).

The reprocessor of a single-use device should be considered to be the manufacturer of the reprocessed device and should assume the obligations incumbent on manufacturers under this Regulation.

The reprocessing of such devices should ensure an equivalent level of safety and performance to that of the corresponding initial single-use device.

Based on the findings of the above mentioned consultations, and in addition to meetings with various stakeholders and fact finding missions both in single use medical device manufacturer premises and reprocessing facilities, the Commission services organised a workshop12 on 5th December 2008 with the aim to collect further data and get a clearer picture of the reprocessing practice, in particular on public health, economic and environmental aspects of the reprocessing of single use medical devices.

Therefore, even if the high price of a new single use medical device could lead to the assumption that the reprocessing is cost-effective, a variation in the price of this device due to an increase in the market competition could reverse completely this assumption.

Of special concern is the potential contamination with transmissible agents such as prions, for which elimination and inactivation is not possible, or the procedure is not compatible with the materials generally used for a single use medical device.

In the absence of quantitative data, it is not possible to quantify the risk associated with the use of reprocessed single use medical device.

The risk is highest when the reprocessed single use medical device is used in a critical procedure, i.e. when used for an invasive medical procedure.

This hazard which also occurs with devices designed for reprocessing and reuse, is characterised by the presence of contaminants of biological origin on the used single use medical device including proteins and micro-organisms such as bacteria and viruses.

It has been shown that a reprocessed single use medical device can be modified in its structure or functionality and may potentially cause some damage to the patient or health-care workers, e.g. mechanical failure of the device.

Inadequate cleaning, disinfection, and/or sterilisation during the reprocessing of single use medical devices introduces the hazard of persistence of a bioburden resulting in a risk of infection during subsequent use of the reprocessed single use medical device for patients and users, as a single use medical device is not designed to be reprocessed.

Some simulation studies and a few clinical studies have shown that reprocessing of single use medical devices may result in improper cleaning, disinfection and/or sterilisation leaving a bioburden on the reprocessed single use medical device, which introduces a risk of infection when using the reprocessed single use medical device.

In addition, these studies do not include a validation to ensure that, after the reprocessing, the reprocessed single use medical device presents an acceptable level of safety, in particular, on functionality and on biocontamination aspects.

The choice of the method of cleaning, disinfection, and/or sterilisation must depend on the chemical composition and nature of the single use medical device.

In addition, changes of the physical and chemical characteristics of the devices may occur which may eventually have an impact on the performance of the reprocessed single use medical device.

It must be noted that the SCENIHR expressed specific concern about the potential contamination with transmissible agents such as prions, for which elimination and inactivation is not possible, or the procedure is not compatible with the materials generally used for a single use medical device.

In order to identify and reduce potential hazards associated with reprocessing of a specific single use medical device, the whole reprocessing cycle starting with the collection of these single use medical devices after (first) use until the final sterilisation and delivery step, including its functional performance, needs to be evaluated and validated.

In order to identify and reduce potential hazards associated with the reprocessing of a specific single use medical device, the whole reprocessing cycle starting with the collection of these single use medical devices after (first) use until the final sterilisation and delivery step, including its functional performance, needs to be evaluated and validated.