Examples of using Self-testing in English and their translations into Slovenian
{-}
-
Colloquial
-
Official
-
Medicine
-
Ecclesiastic
-
Financial
-
Computer
-
Official/political
-
Programming
To be proposed for self-testing:.
Self-testing and virtual testing requirements.
Overview table virtual and/or self-testing.
Self-testing is one of the strongest study techniques there is.
The instructions for use for devices intended for self-testing shall comply with all of the following principles:.
Devices for self-testing must, where reasonably possible, include a method of user control, i. e.
In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
For devices for self-testing, performances obtained by laypersons;
But no matter how long, your levels need to be regularly measured andthat's where INR self-testing is a great benefit.
Self-Sampling and Self-Testing are available in more and more European countries.
The starting date and scheduled duration for the evaluations and, in the case of devices for self-testing, the location and number of lay persons involved.
In the case of devices for self-testing, the information referred to in Annex III, section 6.1.
An accredited in-house technical service of a manufacturer may be designated only forcategory A activities with regard to technical requirements for which self-testing is allowed by a delegated act adopted pursuant to this Regulation.
Devices for self-testing must, where reasonably possible, include user control, i. e.
However, Annex VII applies to EU type-approvals granted under Regulation(EC) No 661/2009 which are based on UNECE regulations(i.e. incorporating new technologies, EU type-approved components and STUs,virtual testing and self-testing).
Medical devices for self-testing not included in List A or List B, andall other in vitro diagnostic medicinal devices.
(5)'device for near-patient testing'means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient;
By self-testing regularly, recording your results and reviewing them with your diabetes care team, you will learn to adjust your diabetes management to maintain your blood glucose levels within agreed targets.
In addition, the CARS 21 Group also identified one directive which could be repealed12 and 25 directives andUN/ECE Regulations in which self-testing and virtual testing could be introduced so as to reduce regulatory compliance costs for industry by making administrative procedures less costly and time-consuming.
Enhanced self-testing functions such as detection of a disconnected lamp, a converter check, and upper and lower limit alarms.
This point 6 also sets out topics for self-testing in accordance with the requirements in Article 64(1) of Regulation(EU) No 168/2013.
For all devices for self-testing other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, prior to the drawing up the EC declaration of conformity in Annex III, fulfill the supplementary requirements set out in Annex III, point 6.
To be designated as a technical service(‘self-testing'), and the possibility of using computer simulations instead of physical tests(‘virtual testing').
(72)“self-testing” means the performance of tests in his or her own facilities, the registration of the test results and the submission of a report, including conclusions, to the approval authority by a manufacturer who has been designated as technical service in order to assess the compliance with certain requirements;
CoaguChek® INRange is the new connected self-testing meter that gives you the freedom to test your PT/INR at home, on the go, or wherever you happen to be.
Devices for self-testing must be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in users' technique and environment.
The information must also specify that when the device for self-testing is used for the monitoring of an existing disease, the patient should only adapt the treatment if he has received the appropriate training to do so;
Device for‘near-patient testing': any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.
For devices covered by Annex II and for devices for self-testing, Member States may request to be informed of the data allowing identification together with the label and the instructions for use when such devices are placed on the market and/or put into service within their territory.