Examples of using Reference laboratory in English and their translations into Croatian
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Colloquial
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Ecclesiastic
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Computer
Decision to establish a European Union reference laboratory.
The reference laboratory shall provide a scientific opinion within 30 days.
The MAH's offer of testing orre-testing antibody(AB) status in a reference laboratory.
The reference laboratory shall inform the notified body about its findings.
The identification and antimicrobial susceptibility tests on any such isolate must be repeated andif the result is confirmed the isolate sent to a reference laboratory.
The EU reference laboratory shall inform the notified body about its findings.
In one cycle of 2017 is planned to send samples with target values obtained in the reference laboratory only for tests in which there are defined reference systems.
The EU reference laboratory shall provide a scientific opinion within 60 days.
However, there is an increasing need for new methods to be developed andproposed for validation, which requires a reference laboratory of the Union for the validation of alternative methods to be established formally.
The reference laboratory shall inform the notified body about its findings Justification.
The detection method specificto Zea mays L., line 1507, as validated by the European Union reference laboratory as referred to in the Annex of Regulation(EC) No 1829/2003 shall be used for the purpose of inspection and control;
The Union Reference Laboratory may collect charges for the services it provides that do not directly contribute to the further advancement of replacement, reduction and refinement.
The frequency of samples of the manufactured devices orbatches of devices classified as class D to be sent to a reference laboratory designated under Article 78 in accordance with Section 5.7 of Annex VIII and Section 5.1 of Annex X, or.
A European Union reference laboratory shall be established where there is a recognised need to promote uniform practices in relation to the development or use of the methods referred to in point(a) of paragraph 1.
Where the changes could affect compliance with the CTS or with other solutions chosen by the manufacturer which were approved through the EU design-examination certificate,the notified body shall consult the reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained.
The EU reference laboratory in Weybridge, Britain, confirmed on Saturday the presence of the H5N1 strain in a dead swan found in Bulgaria's northwestern wetland region of Vidin, close to the Romanian border, and in three wild swans found near Thessaloniki, Greece.
Where notified bodies or Member States request scientific or technical assistance ora scientific opinion from an EU reference laboratory, they shall be required to pay fees to wholly cover the costs incurred by that laboratory in carrying out the requested task according to a set of predetermined and transparent terms and conditions.
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX.
Where notified bodies or Member States request scientific or technical assistance ora scientific opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to predetermined and transparent terms and conditions.
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX.
Where the changes could affect compliance with the CTS or with other solutions chosen by the manufacturer which were approved through the EU type-examination certificate,the notified body shall consult the reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained.
Final opinion: The EU reference laboratory shall then immediately consider that further evidence and adopt a final opinion within 90 days, and inform the natural or legal person requesting to reprocess the single-use device, its manufacturer and the Commission.
Communicate the name and address of each national reference laboratory to the Commission, the relevant European Union reference laboratory and other Member States;
Final opinion: The EU reference laboratory shall consider the original information from the manufacturer and the further evidence provided and adopt a final opinion within 90 days, and inform the natural or legal person requesting to reprocess the single-use device, the manufacturer and the Commission.
Further tests will be conducted at the EU reference laboratory in Weybridge, Britain, to determine whether the birds had the deadly H5N1 form of the virus.
In the event of the EU reference laboratory issuing a negative opinion and that the natural or legal person disagrees with it, the latter may, within 60 days following theadoption of the opinion, provide the concerned EU reference laboratory with further evidence that reprocessing the device will not put patient safety at risk.
Where notified bodies or Member States request scientific or technical assistance ora scientific opinion from an EU reference laboratory, they may shall be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to a set of predetermined and transparent terms and conditions. Am.
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and specificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established infection.
The Croatian case was confirmed by the EU reference laboratory for bird flu in Weybridge, Britain, which tested samples from the swans found last week in the nature park of Zdenci.
In the case of devices classified as class D,request a reference laboratory, where designated in accordance with Article 78, to verify compliance of the device with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.